FORM 00 STUDY VISIT STATUS · INR > 1.5, or history of heparin-induced thrombocytopenia? 1=Yes 2=No...

Study Visit Status v1.0 (11.24.14)

CREST-2 of 1

PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID SITE ID

FORM 00

STUDY VISIT STATUS

Instructions: Answering “No” to Question 3 and locking this form will disable all other forms at this study visit and

open forms for next study visit. 1. Visit date: __ __/ __ __/ __ __ __ __ MM DD YYYY

2. Study visit: ______________ 3. Was this study visit completed within the window specified by study guidelines (i.e., +/- 10 days for 1 month, 4 month, and 8 month visits and +/- 1 month for all remaining visits)? 1=Yes (Skip to Question 3.)

2=No (Complete a Protocol Deviation form [F22].) 3.A. If no, what was the reason for the missed study visit? (Check all that apply.)

1=Scheduling error or difficulties on the part of the study site 1=Scheduling error or difficulties on the part of the patient/caregiver 1=Illness 1=Weather 1=Transportation 1=Other

If other, specify: _______________________________________________

4. Coordinator Code: ___ ___ ___

Inclusion Criteria v1.0 (11.24.14)

CREST-2 Page 1 of 2

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 01 GENERAL INCLUSION CRITERIA

Instructions:

All inclusion criteria must be checked “Yes” or “NA” in order for a participant to be eligible.

1. Screening date: __ __ /__ __ /__ __ __ __ MM DD YYYY

2. Target artery: 1=Right 2=Left 3. Did the patient sign informed consent?

1=Yes

2=No

3.A. If yes, provide date consent signed: __ __ /__ __ /__ __ __ __ MM DD YYYY

4. Is the patient > 35 years old on day of enrollment?

1=Yes

2=No

5. Did the patient agree to comply with all protocol-specified follow-up appointments?

1=Yes

2=No

6. Does the patient have carotid stenosis, defined as:

≥ 70% by catheter angiography (NASCET Criteria);

OR

by DUS with ≥ 70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following: a) an end diastolic velocity ≥ 100 cm/s; or b) internal carotid/ common carotid artery peak systolic

velocity ratio ≥ 4.0; or c) CTA with ≥ 70% stenosis; or d) MRA with ≥ 70% stenosis.

6.A. If yes, was this stenosis defined by: 1= Catheter angiography 2=Ultrasound 3=Both

1=Yes

2=No

Inclusion Criteria v1.0 (11.24.14)

CREST-2 Page 2 of 2

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 01

GENERAL INCLUSION CRITERIA

Instructions:

All inclusion criteria must be checked “Yes” or “NA” in order for a participant to be eligible.

7. Is the patient’s carotid stenosis treatable with either CEA or CAS (or both procedures)?

1=Yes

2=No

8. Is the patient’s medical history free of stroke or TIA ipsilateral to the target lesion within 180 days of randomization?

1=Yes

2=No

9. Is the patient’s modified Rankin score 0 or 1 at the time of informed consent?

1=Yes

2=No

10. If the patient has bilateral carotid stenosis, did any potential treatment of the non-study internal carotid artery take place at greater than 30 days prior to randomization? If patient does not have bilateral carotid stenosis, select ‘N/A’.

1=Yes

2=No

3=NA

11. If patient is female of childbearing potential, was the pregnancy

test negative?

If patient is not of childbearing potential or is male, select ‘N/A’.

1=Yes

2=No

3=NA


General Exclusion Criteria v1.0 (11.24.14)

CREST-2 Page 1 of 5

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 02 GENERAL EXCLUSION CRITERIA

Instructions:

All exclusion criteria must be checked “No” in order for a patient to be eligible.


2. Does the patient have a known intolerance or allergic reaction to a planned study medication without a suitable management alternative?

1=Yes

2=No

3. Has the patient had a GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy?

1=Yes

2=No

4. Does the patient have severe dementia?

1=Yes

2=No

5. Has the patient experienced an intracranial hemorrhage within the past 12 months?

1=Yes

2=No

6. Does the patient have a current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke?

1=Yes

2=No

7. Does the patient object to future blood transfusions?

1=Yes

2=No

8. Does the patient have a platelet count < 100,000/l, uncorrected INR > 1.5, or history of heparin-induced thrombocytopenia?

1=Yes

2=No

9. Is the patient on anticoagulation therapy with Phenprocoumon (Marcumar®), warfarin, a direct thrombin inhibition, or anti-Xa agents?

1=Yes

2=No

10. Does the patient have chronic atrial fibrillation?

1=Yes

2=No


CREST-2 Page 2 of 5

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 02

GENERAL EXCLUSION CRITERIA

Instructions:

All exclusion criteria must be checked “No” in order for a patient to be eligible.

11. Has the patient had any episode of atrial fibrillation within the past 6 months (or a history of paroxysmal atrial fibrillation) that is deemed to require chronic anticoagulation?

1=Yes

2=No

12. Does the patient have other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass or known unrepaired PFO with prior paradoxical embolism?

1=Yes

2=No

13. Does the patient have unstable angina defined as rest angina with ECG changes that is not amenable to revascularization? (NOTE: Patients should undergo planned coronary revascularization at least 30 days before randomization.)

1=Yes

2=No

14. Does the patient have an ejection fraction < 30% or admission for heart failure in prior 6 months?

1=Yes

2=No

15. Does the patient have respiratory insufficiency with life expectancy < 4 years or FEV1< 30% of predicted value?

1=Yes

2=No

16. Does the patient have a known malignancy (other than non-melanoma skin cancer)? (NOTE: Those patients with prior treatment and no recurrence for >5 years are eligible for enrollment.)

1=Yes

2=No

17. Has the patient had any major surgery, major trauma, non-coronary revascularization procedure, or acute coronary syndrome within the past 30 days?

1=Yes

2=No


CREST-2 Page 3 of 5

PID1: __ __ __ - __ __ __ __ SITE ID


Instructions:

All exclusion criteria must be checked “No” in order for a participant to be eligible.

18. Is the patient’s serum creatinine ≥ 2.5 mg/dl or estimated GFR ≤ 50cc/min at screening?

1=Yes

2=No

19. Does the patient have any major (non-carotid) surgery or procedures planned within 3 months after enrollment?

1=Yes

2=No

20. Is the patient currently listed or being evaluated for major organ transplantation (e.g., heart, lung, liver, or kidney)?

1=Yes

2=No

21. Is the patient actively participating in another drug or device trial that has not completed follow-up?

1=Yes

2=No

22. Does the patient have an inability to understand and cooperate with study procedures or provide informed consent?

1=Yes

2=No

23. Does the patient have non-atherosclerotic carotid stenosis of the target artery (e.g., dissection, fibromuscular dysplasia, or stenosis following radiation therapy)?

1=Yes

2=No

24. Has the patient had previous CEA or CAS to the target artery?

1=Yes

2=No

25. Does the patient have an internal or common carotid artery occlusion of the target artery?

1=Yes

2=No

26. Does the patient have an intra-carotid floating thrombus?

1=Yes

2=No

27. Does the patient have an ipsilateral intracranial aneurysm > 5mm?

1=Yes

2=No


CREST-2 Page 4 of 5

PID1: __ __ __ - __ __ __ __ SITE ID


Instructions:


28. Is the patient classified as WHO Class III obesity (i.e., BMI > 40 kg/m2)?

1=Yes

2=No

29. Does the patient have a non-target common or non-target internal carotid artery occlusion?

1=Yes

2=No

30. Does the patient have coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized?

1=Yes

2=No

31. Does the patient have any of the following anatomical conditions:

radical neck dissection; surgically inaccessible lesions (e.g., above cervical spine level 2

(C2)); adverse neck anatomy that limits surgical exposure (e.g., spinal

immobility – inability to flex neck beyond neutral or kyphotic deformity, or short obese neck);

presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure

ipsilateral to the target vessel.

1=Yes

2=No

32. Does the patient have occlusive or critical ilio-femoral disease, including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch?

1=Yes

2=No

33. Does the patient have qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, in combination with elements that preclude safe sheath placement?

1=Yes

2=No


CREST-2 Page 5 of 5

PID1: __ __ __ - __ __ __ __ SITE ID


Instructions:


34. Does the patient have “string sign” of the target common or internal carotid artery?

1=Yes

2=No

35. Does the patient have angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries?

1=Yes

2=No


CEA Specific Exclusion Criteria v1.0 (11.24.14)

CREST-2 Page 1 of 1

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 03A CAROTID ENDARTERECTOMY (CEA) SPECIFIC EXCLUSION CRITERIA

Instructions:


NOTE: For age < 50 years, CAS is the favored procedure. However, the CREST results for asymptomatic patients showed wide confidence intervals about the point estimates comparing CAS and CEA. Accordingly, choice of CEA or CAS cannot be mandated; individual patient characteristics and preferences may supersede guidelines based upon patient age.


2. Does the patient have a known serious adverse reaction to anesthesia

that cannot be overcome by pre-medication?

1=Yes

2=No

3. Coordinator Code:___ ___ ___

CAS Specific Exclusion Criteria v1.0 (11.24.14)

CREST-2 Page 1 of 2

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 03B CAROTID ARTERY STENTING (CAS) SPECIFIC EXCLUSION CRITERIA

Instructions:


NOTE: For patients > 74 years of age, CEA is the favored procedure. However, the CREST results for asymptomatic patients showed wide confidence intervals about the point estimates comparing CAS and CEA. Accordingly, choice of CEA or CAS cannot be mandated; individual patient characteristics and preferences may supersede guidelines based upon patient age.


2. Does the patient have a known allergy to intravascular contrast dye

not amenable to pre-medication?

1=Yes

2=No

3. Does the patient have a known Type III, aortic arch anatomy?

1=Yes

2=No

4. Does the patient have a known angulation or tortuosity (≥ 90 degree)

of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement?

1=Yes

2=No

5. Does patient have a known severe angulation or tortuosity of the

internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent?

NOTE: Severe tortuosity is defined as 2 or more ≥ 90 degree angles

within 4 cm of the target stenosis.

1=Yes

2=No

6. Does the patient have a known proximal/ostial CCA, innominate

stenosis or distal/intracranial stenosis greater than target vessel?

1=Yes

2=No

7. Does the patient have a known excessive circumferential calcification

of the stenotic lesion, defined as > 3mm thickness of calcification seen in orthogonal views on fluoroscopy?

NOTE: Anatomic considerations such as tortuosity, arch anatomy,

and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).

1=Yes

2=No

CAS Specific Exclusion Criteria v1.0 (11.24.14)

CREST-2 Page 2 of 2

PID1: __ __ __ - __ __ __ __ SITE ID

FORM 03B CAROTID ARTERY STENTING (CAS) SPECIFIC EXCLUSION CRITERIA

Instructions:


8. Does the patient have target ICA vessel reference diameter < 4.0 mm or

> 9.0 mm? NOTE: Target ICA measurements may be made from angiography of

the non-target artery. The reference diameter must be appropriate for the devices to be used.

1=Yes

2=No

9. Does the site have inability to deploy or utilize an FDA-approved

Embolic Protection Device (EPD)?

1=Yes

2=No

10. Does the patient have non-contiguous lesions and long lesions (> 3 cm)?

1=Yes

2=No


Randomization v2.0 (01.27.15)

CREST-2 Page 1 of 4 PID1: __ __ __ - __ __ __ __ SITE ID

FORM 04

RANDOMIZATON


2. Target artery: 1=Right 2=Left

Instructions: Eligibility for randomization can be determined by ultrasound or catheter-based angiography.

3. Was a baseline protocol ultrasound performed on the target artery within the past 90 days? 1=Yes 2=No

NOTE: If baseline protocol ultrasound has not been completed, patient is not eligible for randomization.

3.A. If yes, provide date completed: __ __ /__ __ /__ __ __ __

MM DD YYYY

NOTE: Please provide a response to each of Questions 3.B., 3.C., 3.D. and 3.E. If eligibility for randomization is established by ultrasound, at least one of these questions must have a ‘Yes’ response. 3.B. Did the patient have an internal carotid artery peak systolic velocity of at least 230 cm/s plus an end diastolic velocity ≥ 100 cm/s? 1=Yes 2=No 3.C. Did the patient have an internal carotid artery peak systolic velocity on DUS of at least 230 cm/s plus an internal carotid/ common carotid artery peak systolic velocity ratio ≥ 4.0? 1=Yes 2=No 3.D. Did the patient have an internal carotid artery peak systolic velocity on DUS of at least 230 cm/s plus CTA confirmation of ≥ 70% stenosis within the past 90 days? 1=Yes 2=No If yes, please provide date of most current CTA: 3.D.1: Date of CTA: __ __ /__ __ /__ __ __ __ MM DD YYYY



FORM 04 RANDOMIZATON

3.E. Did the patient have an internal carotid artery peak systolic velocity on DUS of at least 230 cm/s plus MRA confirmation of ≥ 70% stenosis within the past 90 days? 1=Yes 2=No If yes, please provide date from the most current MRA: 3.E.1: Date of MRA: __ __ /__ __ /__ __ __ __ MM DD YYYY

4. Was catheter-based angiography performed on the target vessel within the past 90 days?

1=Yes 2=No If yes, please provide data from the most current catheter-based angiogram:

4.A. CBA Data: 4.A.1: Date of CBA: __ __ /__ __ /__ __ __ __ MM DD YYYY

4.A.2: CBA target lesion minimal residual lumen: __. __ mm (a)

4.A.3: CBA reference diameter (internal carotid distal to target lesion at point when

artery walls return to parallel): __ __. __ mm (c)

4.A.4: CBA target lesion % diameter stenosis: __ __ __ % [Formula: (1 – [ a/c]) x 100)] NOTE: Round answer down to the nearest whole percent. NOTE: If eligibility is established by CBA, stenosis must be >70%.


CREST-2 Page 3 of 4

PID1: __ __ __ - __ __ __ __ SITE ID


5. What was the symptomatic status of the target artery? 1=Lifelong asymptomatic (Skip to Question 6.) 2=Previous stroke/ TIA 5.A. If previous stroke/TIA, record date of most recent event: __ __/__ __/__ __ __ __ MM DD YYYY NOTE: Exact date is not required as long as the partial date definitively defines >180 days. NOTE: If the target artery was symptomatic and the recent symptoms are less than or equal to 180 days, the patient is not eligible for randomization. 6. Has the symptomatic status of the patient been confirmed by the CREST-2 Principal Investigator? 1=Yes 2=No 7. Is the patient eligible for randomization? 1=Yes 2=No

7.A. If ineligible, please provide reason: ____________________________________________ 8. In what trial is the patient being enrolled? (NOTE: This is the trial selection critical point.) 1=Carotid Endarterectomy (CEA) Form 03A must be completed and locked. 2=Carotid Artery Stenting (CAS) Form 03B must be completed and locked. 9. In the event that the patient is randomized to a procedure, has the availability of the surgeon or interventionalist been confirmed within the next two weeks? 1=Yes 2=No 9.A. If yes, scheduled procedure date: __ __ /__ __ /__ __ __ __ MM DD YYYY




10. Date patient randomized: __ __ /__ __ /__ __ __ __ MM DD YYYY

11. Coordinator Code: ___ ___ ___ Lock form to randomize patient and generate e-mail notification. Record PID2 and study arm from system message, if desired. 12. New PID (PID2) assigned: ___ ___ ___ ___ ___ ID

13. Patient randomized to the following study arm: 1=Procedure + Intensive Medical Management (IMM) 2=IMM alone

Demographics and Social Status v1.0 (11.24.14)

CREST-2 Page 1 of 3 PID1: __ __ __ - __ __ __ __ PID2: __ __ __ - __ __ __ __ __ SITE ID SITE ID

FORM 05 DEMOGRAPHICS AND SOCIAL STATUS

1. Visit date: __ __ /__ __ /__ __ __ __

MM DD YYYY

Instructions: Complete all questions, based on participant report.

2.A. Age: __ __ years 2.B. Year of birth: __ __ __ __ 3. Gender: (Select only one response.)

1=Male

2=Female 3=Unspecified 4=Unreported -9=Unknown

4. Race: (Select all that apply.)

1=American Indian / Alaska Native 1=Asian 1=Black / African-American 1=Caucasian / White 1=Native Hawaiian / Other Pacific Islander 1=Not reported 1=Unknown NOTE: If ‘Not reported’ or ‘Unknown’ is selected, none of the other categories can be selected.

5. Ethnicity: (Select the one category with which the patient most closely identifies.)

1=Hispanic or Latino 2=Not Hispanic or Latino 3=Not reported -9=Unknown




6. Education level: (Select the highest level attained.)

0=Never attended/ Kindergarten only

1=1st grade

2=2nd grade

3=3rd grade

4=4th grade

5=5th grade

6=6th grade

7=7th grade

8=8th grade

9=9th grade

10=10th grade

11=11th grade

12=12th grade, no diploma

13=High school graduate

14=GED or equivalent

15=Some college, no degree

16=Associate degree: occupational/technical/vocational program

17=Associate degree: academic program

18=Bachelor's degree (e.g., BA, AB, BS, BBA)

19=Master's degree (e.g., MA, MS, MEng, MEd, MBA)

20=Professional school degree (e.g., MD, DDS, DVM, JD)

21=Doctoral degree (e.g., PhD, EdD)

-9=Unknown




7. What is the language that the patient speaks most often? (Select only one response.)

1=English

2=Spanish

3=French

4=German

5=Chinese languages

6=Sign languages

7=Other, specify: _________________________________________________________

8. Is the patient fluent enough in English to complete the cognitive assessment and communicate with INTERVENT counselors?

1=Yes 2=No


Baseline Medical History v1.0 (11.24.14)

CREST-2 Page 1 of 5

PID1: __ __ __ - __ __ __ __ PID2: __ __ __ - __ __ __ __ __ SITE ID SITE ID

FORM 06

BASELINE MEDICAL HISTORY Instructions: Does the patient have (or has had) any of the following?

1. Visit date: __ __ /__ __ /__ __ __ __ MM DD YYYY

2. Migraine(s)

1 = Yes

2 = No

-9 = Unknown

2.A. If yes, migraines with aura:

1 = Yes

2 = No

-9 = Unknown

3. Contralateral carotid endarterectomy

1 = Yes 2 = No -9 = Unknown

4. Contralateral carotid artery stenting


5. Epilepsy/ seizure disorder


6. Dementia


7. Current clinical depression


8. Coronary artery disease


9. Myocardial infarction


10. Angina


11. Valvular heart disease


12. Cardiac surgery

12.A. If yes, indicate type(s):



CREST-2 Page 2 of 5


FORM 06 BASELINE MEDICAL HISTORY

12.A.1.Coronary artery bypass graft (CABG)


12.A.2. Cardiac valve surgery, including

non-open surgery


12.A.3. Other

12.A.3.1 If yes, specify: ________________________


13. Artificial valve


14. Coronary stent or PTCA


15. Congestive heart failure


16. Congenital heart disease


17. Peripheral arterial disease


18. Hypertension


19. Diabetes mellitus

1 =Yes 2 = No -9 = Unknown

19.A. If yes, record the complication(s) of diabetes: (Select all that apply.) 1=No complications 1=Nephropathy 1=Neuropathy 1=Retinopathy

1=Other (specify): ___________________________________________________________

19.B. If yes, record treatment(s) for diabetes: (Select all that apply.) 1=No treatment 1=Diet 1=Oral Medication 1=Insulin


CREST-2 Page 3 of 5



20. High blood cholesterol/

hypercholesterolemia 1 = Yes 2 = No -9 =Unknown

20.A. If yes, indicate treatment(s): (Choose all that apply.)

1=No treatment 1=Diet 1=Statins 1=Other medicines

21. Hypertriglyceridemia

1 = Yes 2 = No -9 =Unknown

22. Sleep apnea 1 = Yes 2 = No -9 =Unknown

22.A. If yes, specify type of sleep apnea: _______________________________________________

23. Is there presence of left ventricular

hypertrophy by electrocardiogram (ECG) or echocardiogram (ECHO)?

1 = Yes 2 = No 3 = ECG not done

24. Ischemic stroke

1 = Yes

2 = No

-9 = Unknown

24.A. If yes, what side was involved?

24.B. If yes, date of ischemic stroke:

__ __ / __ __ / __ __ __ __ MM DD YYYY

Check all that apply: 1 = Right carotid 1 = Left carotid 1 = Vertebrobasilar 1 = Unknown

25. Transient ischemic attack (TIA)

1 = Yes

2 = No

-9 = Unknown

25.A. If yes, what side was involved?

25.B. If yes, date of TIA: __ __ / __ __ / __ __ __ __ MM DD YYYY

Check all that apply: 1 = Right carotid 1 = Left carotid 1 = Vertebrobasilar 1 = Unknown

26. When was the stenosis of the target artery first identified? __ __ / __ __ / __ __ __ __ MM DD YYYY

26.A. What was the degree of stenosis at that time? 1 = 50 – 69% (or your local lab equivalent) 2 = 70 – 99% (or your local lab equivalent)


CREST-2 Page 4 of 5



27. Current tobacco use? (Regular use of cigarettes, cigars, chewing tobacco or pipes within past year.)


28. Past tobacco use? (Regular use of cigarettes, cigars, chewing tobacco or pipes prior to the past year.)

1 = Yes 2 = No -9 = Unknown 29. Current smoking status: (Select only one.)

1 = I never smoked. 2 = I smoke now, and I don’t intend to quit within the next 6 months. How many cigarettes do you smoke a day? __ __ cigarettes

3 = I smoke now, but I have been thinking of quitting soon. How many cigarettes do you smoke a day? __ __ cigarettes

4 = I’m trying to quit, but I have frequent slips. How many cigarettes do you smoke a day? __ __ cigarettes

5 = I quit smoking 1-6 months ago and have stayed quit.

6 = I quit smoking 7 or more months ago and have stayed quit.

30. How often do you have a drink containing alcohol? 1=Never 2=Monthly or less 3=2 to 4 times a month 4=2 to 3 times a week 5=4 or more times a week -9=Unknown


CREST-2 Page 5 of 5


FORM 06

BASELINE MEDICAL HISTORY

31. Current physical activity status: (Choose only one.) This form will help your health care provider understand your level of physical activity. Please read the entire form and then choose the ONE number below that best describes your current level of physical activity or your readiness to do more physical activity. Do not include activities you do as part of your job. “Vigorous” exercise includes activities like jogging, running, fast cycling, aerobics classes, swimming laps, singles tennis, and racquetball. Any activity that makes you work as hard as jogging and lasts 20 minutes at a time should be counted. These types of activities usually increase your heart rate, and make you sweat, and you get out of breath. (Do not count weight lifting.) Regular vigorous exercises is done for at least 20 minutes at a time and at least 3 days a week. “Moderate” exercise includes activities like brisk walking, gardening, slow cycling, dancing, doubles tennis, or hard work around the house. Any activity that makes you work as hard as brisk walking and that lasts at least 10 minutes at a time should be counted. Regular moderate exercise is done at least 30 minutes a day and at least 5 days a week. 1 = I don’t do regular vigorous or moderate exercise now, and I don’t intend to start in the

next 6 months. 2 = I don’t do regular vigorous or moderate exercise now, but I have been thinking of

starting in the next 6 months. 3 = I’m trying to start doing vigorous or moderate exercise, but I don’t do it regularly (i.e weekly). 4 = I’m doing vigorous exercise regularly but less than 3 times per week (or) moderate exercise regularly but less than 5 times per week. 5 = I’ve been doing 30 minutes a day of moderate exercise 5 or more days per week for the

last 1-5 months. 6 = I’ve been doing 30 minutes a day of moderate exercise 5 or more days per week for the

last 6 months or more. 7 = I’ve been doing vigorous exercise 3 or more days per week for the last 1-5 months. 8 = I’ve been doing vigorous exercise 3 or more days per week for the last 6 months or more.


Baseline Vital Signs v1.0 (11.24.14)

CREST-2 Page 1 of 2 PID1: __ __ __ - __ __ __ __ PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID SITE ID

FORM 07

BASELINE VITAL SIGNS


CREST-2 BP MEASUREMENT PROTOCOL INSTRUCTIONS: 1. No caffeine or tobacco within prior 60 minutes. 2. Sitting position; “selected” arm relaxed and supported at level of the heart after 15 minutes of sitting quietly. 3. Select correct cuff size:

Omron cuff size Fits arm circumference small 7-9 inches regular 9-13 inches large > 13 inches

4. Minimize physical contact during measurement. 5. Take three readings separated by > 2 minutes. 6. Record the reading using the Omron electronic device. 7. Orthostatic (standing) measurements obtained after sitting BPs are measured, as indicated.

2. Patient position (protocol is sitting): 1=Sitting 2=Standing 3=Lying (Note: Measure all 3 blood pressures with patient in the same position.)

3. From what arm was blood pressure taken? 1=Right 2=Left (Note: Right arm preferred.) 4. Reading taken with (protocol is study device):

4.A. 1=Study device 2=Manual Cuff 3=Other, specify: ______________________ (Omron)

4.B. 1st reading, mmHg: / systolic diastolic

4.C. 2nd reading, mmHg: / systolic diastolic

4.D. 3rd reading, mmHg: / systolic diastolic

4.E. Mean of 3 readings, mmHg: / systolic diastolic (Note: Round down to nearest whole digit for the mean of 3 readings.)

Baseline Vital Signs v1.0 (11.24.14)

CREST-2 Page 2 of 2 PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID SITE ID

FORM 07 BASELINE VITAL SIGNS

5. Heart rate: beats/min (Note: Record lowest heart rate reading from the above 3 blood pressure recordings.)

6. Standing blood pressure reading, mmHg: / systolic diastolic

7. Was the study risk factor physician advised of above readings on the same day as the visit?

1 = Yes 2 = No

7.A. If no, provide reason: ____________________________________________________________

8. Are the blood pressure medications being changed as a result of this baseline visit?

1 = Yes 2 = No If yes, make the appropriate changes to the Medications form (F08). If the medication change was a diuretic or ACE inhibitor, the patient should have safety labs (potassium and creatinine) in 30 days. 8.A. If no and average SBP is >=140, provide reason: (Check all that apply.)

1=SBP drop of > 15 when standing 1=Side-effects (Complete Adverse Event form [F26].)

1=Non-compliance 1=Other If other, specify reason: __________________________

9. Height:

9.A. Unit: 1= Inches 2=Centimeters 9.B. Height: . . (e.g., 6 feet recorded as 072.0 inches)

10. Weight:

10.A. Unit: 1= Pounds 2=Kilograms 10.B. Weight: .


Medications v1.0 (11.24.14)

CREST-2 Page ____ of ____ PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID SITE ID

FORM 08 MEDICATION FORM

Start Date Stop Date

#___. ___ ___ ___ ________ ________ _____ _____ Medication Code MM DD YYYY MM DD YYYY Dose Units Route Frequency Text for Rx that does not have a code:__________________________________ Text for other unit, route, frequency:____________ Start Date Stop Date




#___. ___ ___ ___ ________ ________ _____ _____ Medication Code MM DD YYYY MM DD YYYY Dose Units Route Frequency Text for Rx that does not have a code:__________________________________ Text for other unit, route, frequency:____________


CREST-2 Page 1 of 2


FORM 08 MEDICATIONS FORM


2. Visit: 1=Scheduled ___________________ 2=Unscheduled 3=Dosage change adjustment 9=Other If “Other”, specify: _____________________________________________ 3. Is the patient taking aspirin and/or prescription medications? 1=Yes 2=No 4. Coordinator Code: ___ ___ ___

5. Medication code: ___ ___ ___ (Note: If medication is not included in coding list, enter 999.) 5.A. If medication not included in coding list, specify:___________________________________ (Note: Please provide generic name where possible.)

5.B. Is the start date known? 1=Yes 2=No 5.B.1. If yes, enter start date: __ __ /__ __ /__ __ __ __ MM DD YYYY

(Note: If start date unknown, enter 99/99/9999.) 5.C. Is the subject still taking the medication? 1=Yes 2=No 5.C.1. If no, please indicate stop date: __ __ /__ __ /__ __ __ __ MM DD YYYY

(Note: If end date unknown, enter 99/99/9999.) 5.D. Total daily dose: __ __ __ __ __ . __ __ OR 1=Other Dose If “Other”, specify:___________________________________


CREST-2 Page 2 of 2


FORM 08

MEDICATIONS FORM

5.E. Dose units: (Select ONLY one.) 1=g 2=mg 3=g 4=Application 5=IU 9=Other 5.E.1. If “Other”, specify: __________________________________________ 5.F. Frequency: (Select ONLY one.) 1=Every day (QD) 2=Twice daily (BID) 3=Three times daily (TID) 4=Four times daily (QID) 5=Every hour 6=One time only (X1) 7=As occasion requires (PRN) 9=Other 5.F.1. If “Other”, specify: _________________________________________ 5.G. Route: (Select ONLY one.) 01=Oral 02=Sublingual 03=Subcutaneous 04=Intramuscular 05=Transdermal 06=Intravenous 07=Rectal 08=Intra-arterial 09=Intra-thecal 99=Other 5.G.1. If “Other”, specify: _________________________________________



FORM 08 MEDICATIONS FORM

1. Visit date: __ __/ __ __/ __ __ __ __ 2. Visit: _______________________ MM DD YYYY

3. Is the patient taking any daily prescription medications or aspirin at the time of this visit? 1=Yes 2=No


Instructions: At enrollment, list all medications (aspirin and prescription drugs) that patient is taking. For medication codes, see list in the MOP. Update form at each patient contact. A dosage change or restarting a previously stopped medication should be recorded as a new medication. When page 2 is filled, add an additional page. Do not record procedural required medications. If start date is not known enter all 99/99/9999. Dose Units 1 = g 2 = mg 3 = µg; 4 = Application 5 = IU

9 = Other (specify on other unit, route and frequency line)

Route 1 = Oral 2 = Sublingual 3 = Subcutaneous 4 = Intramuscular 5 = Transdermal

6 = Intravenous 7 = Rectal 8 = Intraarterial 9 = Intrathecal 99 = Other (specify on other unit, route and frequency line)

Frequency 1 = Every day (QD) 2 = Twice daily (BID) 3 = three times daily (TID) 4 = four times daily (QID)

5 = every hour 6 = one time only (X1) 7 = As occasion requires (PRN) 99 = Other (specify on other unit, route and frequency line)


CREST-2 Page 2 of ___ PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID SITE ID

FORM 08 MEDICATION FORM

Start Date Stop Date

1. ___ ___ ___ ________ ________ _____ _____ Medication Code MM DD YYYY MM DD YYYY Dose Units Route Frequency Text for Rx that does not have a code:__________________________________ Text for other unit, route, frequency:____________ Start Date Stop Date




5. ___ ___ ___ ________ ________ _____ _____ Medication Code MM DD YYYY MM DD YYYY Dose Units Route Frequency Text for Rx that does not have a code:___________________________________ Text for other unit, route, frequency:____________

Modified Rankin Score v1.0 (11.24.14)

CREST-2 Page 1 of 1


FORM 09

MODIFIED RANKIN (mRS) SCALE

1. Was the Modified Rankin Scale completed? 1=Yes 2=No

1.A. If yes, date completed: __ __ /__ __ /__ __ __ __

MM DD YYYY

If no, skip remainder of form and complete a Protocol Deviation form (F22). 2. Study visit: __________

SCORE

3. Score:

0 = No symptoms at all.

1 = No significant disability despite symptoms; able to carry out all usual duties and activities.

2 = Slight disability; unable to carry out all previous activities but able to

look after own affairs without assistance.

3 = Moderate disability requiring some help, but able to walk without assistance.

4 = Moderate severe disability; unable to walk without assistance and

unable to attend to own bodily needs without assistance.

5 = Severe disability; bedridden, incontinent, and requiring constant nursing care and assistance.

6 = Dead.

____


SCORE 3.A. Level of Consciousness (LOC) 0=Alert 1=Drowsy 2=Stuporous 3=Coma

_____

3.B. LOC Questions 0=Both correct 1=One correct 2=Both incorrect

_____

3.C. LOC Commands 0=Obeys both correctly 1=Obeys one correctly 2=Both incorrect

_____

4. Best Gaze 0=Normal 1=Partial gaze palsy 2=Forced evaluation

_____

5. Visual 0=No visual loss 1=Partial hemianopia 2=Complete hemianopia 3=Bilateral hemianopia

_____

6. Facial palsy 0=Normal facial movement 1=Minor paresis 2=Partial paresis 3=Complete palsy

_____

7.A. Motor Arm-Left 0=No drift (Elevate extremity 90° and score 1=Drift drift/movement) 2=Some effort against gravity 3=No effort against gravity 4=No movement 9=UN (amputation or joint fusion) Explain: ________________________

_____


FORM 10 NIH STROKE SCALE (NIHSS)

1. Was the NIH Stroke Scale completed? 1=Yes 2=No


MM DD YYYY

If no, skip remainder of form and complete a Protocol Deviation form (F22).

2. Study visit: __________

NIH Stroke Scale v1.0 (11.24.14)



SCORE 7.B. Motor Arm-Right 0=No drift (Elevate extremity 90° and 1=Drift score drift/movement) 2=Some effort against gravity 3=No effort against gravity 4=No movement 9=UN (amputation or joint fusion) Explain: ________________________

_____

8.A. Motor Leg-Left 0=No drift (Elevate extremity 30° and 1=Drift score drift/movement) 2=Some effort against gravity 3=No effort against gravity 4=No movement 9=UN (amputation or joint fusion) Explain: ________________________

_____

8.B. Motor Leg-Right 0=No drift (Elevate extremity 30° and 1=Drift score drift/movement) 2=Some effort against gravity 3=No effort against gravity 4=No movement 9=UN (amputation or joint fusion) Explain: ________________________

_____

9. Limb Ataxia 0=Absent (Finger-nose, heel down shin) 1=Present in upper or lower 2=Present in both 9=UN (amputation or joint fusion) Explain: ________________________

_____

10. Sensory 0=Normal (Pin prick to face, arm, trunk, 1=Partial loss and leg; compare side to side) 2=Dense loss

_____

11. Best language 0=No aphasia (Name items, describe a picture and 1=Mild-moderate aphasia read sentences) 2=Severe aphasia 3=Mute

_____

12. Dysarthria 0=Normal articulation (Evaluate speech clarity by patient 1=Mild-moderate slurring repeating listed words) 2=Severe, nearly intelligible or worse 9=UN (intubated or other physical barrier) Explain: ________________________

_____

13. Extinction and Inattention 0=No neglect (Use information from prior testing 1=Partial neglect to identify neglect or double 2=Profound neglect simultaneous stimuli testing)

_____

NIH Stroke Scale TOTAL: (Do not include scores of ‘9’ in total) _____




14. RATER MUST BE CERTIFIED IN ADMINISTRATION OF NIH STROKE SCALE. 14.A. Rater’s name: _______________________________________ 14.B. Rater’s code: ___ ___ ___

PLEASE SKIP QUESTIONS 15 AND 16 AT THE BASELINE VISIT; COMPLETE THESE QUESTION AT ALL FOLLOW-UP VISITS: 15. Last NIHSS score: __ __ 16. In comparison to the patient’s last NIHSS score, did the patient have a 2-point (or more) increase in one or more items (Questions 3.A. – 13)?

1=Yes 2=No If yes, initiate stroke endpoint review process.


Baseline Questionnaire for Verifying Stroke-Free Status v1.0 (11.24.14)

CREST-2 Page 1 of 1


FORM 11

BASELINE QUESTIONNAIRE FOR VERIFYING STROKE-FREE STATUS (QVSS) Instructions:

This form is to be used for the CREST-2 baseline visit only.

Complete all items, selecting only one response for Questions 2-9. 1. Was the baseline QVSS completed? 1=Yes 2=No


MM DD YYYY


2. Were you ever told by a physician that you had a

stroke?

1=Yes

2=No

-9=Unknown

3. Were you ever told by a physician that you had a TIA, mini-stroke, or transient ischemic attack?

1=Yes

2=No

-9=Unknown

4. Have you ever had sudden painless weakness on one

side of your body?

1=Yes

2=No

-9=Unknown

5. Have you ever had sudden numbness or a dead

feeling on one side of your body?

1=Yes

2=No

-9=Unknown

6. Have you ever had sudden painless loss of vision in

one or both eyes?

1=Yes

2=No

--9=Unknown

7. Have you ever suddenly lost one half of your vision?

1=Yes

2=No

-9=Unknown

8. Have you ever suddenly lost the ability to understand what people were saying?

1=Yes

2=No

-9=Unknown

9. Have you ever suddenly lost the ability to express yourself verbally or in writing?

1=Yes

2=No

--9=Unknown


Follow-Up Questionnaire for Verifying Stroke-Free Status v1.0 (11.24.14)

CREST-2 Page 1 of 2


FORM 12

FOLLOW-UP QUESTIONNAIRE FOR VERIFYING STROKE-FREE STATUS (QVSS)

Instructions:

This form is to be used during the CREST-2 follow-up visits, either in person or by telephone.

Remind respondent of last contact.

Complete all items, selecting only one response for questions 4-11.

If any of the questions 4-11 are answered “Yes”, follow procedures for a stroke; that is, complete the Stroke/TIA Event form (F27), Cranial Nerve Palsy Event form (F28), NIH Stroke Scale (F10), etc.

1. Was the follow-up QVSS completed? 1=Yes 2=No

1.A. If yes, date completed: __ __ /__ __ /__ __ __ __ MM DD YYYY


2. Study visit: ____________

3. Form completed: 1=In person 2=By phone

4. Since the last routine CREST-2 contact by phone or in the clinic, have you been told by a physician that you have had a stroke?

1=Yes

2=No

-9=Unknown

5. Since the last routine CREST-2 contact by phone or in the clinic, were you ever told by a physician that you had a TIA, mini-stroke, or transient ischemic attack?

1=Yes

2=No

-9=Unknown

6. Since the last routine CREST-2 contact by phone or in the clinic, have you ever had sudden painless weakness on one side of your body?

1=Yes

2=No

-9=Unknown

Follow-Up Questionnaire for Verifying Stroke-Free Status v1.0 (11.24.14)

CREST-2 Page 2 of 2


FORM 12

FOLLOW-UP QUESTIONNAIRE FOR VERIFYING STROKE-FREE STATUS (QVSS)

7. Since the last routine CREST-2 contact by phone or in the clinic, have you had sudden numbness or a dead feeling on one side of your body?

1=Yes

2=No

-9=Unknown

8. Since the last routine CREST-2 contact by phone or in the clinic, have you had sudden painless loss of vision in one or both eyes?

1=Yes

2=No

-9=Unknown

9. Since the last routine CREST-2 contact by phone or in the clinic, have you ever suddenly lost one half of your vision?

1=Yes

2=No

-9=Unknown

10. Since the last routine CREST-2 contact by phone or in the clinic, have you ever suddenly lost the ability to understand what people were saying?

1=Yes

2=No

-9=Unknown

11. Since the last routine CREST-2 contact by phone or in the clinic, have you ever suddenly lost the ability to express yourself verbally or in writing?

1=Yes

2=No

-9=Unknown


Follow-Up Vital Signs and Medical History v1.0 (11.24.14)


FORM 13 FOLLOW-UP VITAL SIGNS AND MEDICAL HISTORY

1. Visit date: __ __ /__ __ /__ __ __ __ 1.A. Visit: ___________

MM DD YYYY

2. Was this form completed at this visit? 1=Yes 2=No

2.A. How was information obtained for this visit? 1=In-person 2=Telephone (Note: If telephone, skip to Question 12.)

VITAL SIGNS

CREST-2 BP MEASUREMENT INSTRUCTIONS: 1..No caffeine or tobacco within prior 60 minutes 2. Sitting position is protocol; “selected” arm relaxed and supported at level of the heart after 15 minutes of sitting quietly. 3.Select correct cuff size:


4. Minimize physical contact during measurement. 5. Take three readings separated by > 2 minutes. 6. Record the reading using the Omron electronic device 7. Orthostatic (standing) measurements obtained after sitting BPs are measured as indicated.


4. From what arm was blood pressure taken (right preferred)? 1=Right 2=Left

5. Reading taken with (protocol is study device): (Attach print out from study device.)

5.A. 1=Study device 2=Manual Cuff 3=Other, specify: _________________________ (Omron)




5.E. Mean of 3 readings, mmHg: / systolic diastolic

(Note: Round down to the nearest whole digit for the mean of 3 readings.)




6. Heart rate: beats/min Note: Record lowest heart rate reading from the above 3 blood pressure recordings.

7. Standing blood pressure reading (if required), mmHg: / systolic diastolic Required at the following time points: 1. if patient reports orthostatic symptoms (reports lightheadedness on standing); and/or 2. If standing BP dropped > 15 mmHg at last visit.

8. Was the study risk factor physician advised of above readings on the same day as the visit?

1 = Yes 2 = No 8.A. If no, specify:______________________________________________________________________

9. Are the blood pressure medications being changed at this visit? 1 = Yes 2 = No If yes, make the appropriate changes to the Medications form (F08). If the medication change was a diuretic or ACE inhibitor, the patient should have safety labs (potassium and creatinine) in 30 days. 9.A. If no and SBP is >140, provide reason:

1=SBP drop of > 15 when standing 2=Side-effects (Complete AE form [F26].)

3=Non-compliance 4=Other If other, specify reason: ____________________________

10. Is an extra BP visit necessary in 30 days to re-evaluate blood pressure?

1 = Yes 2 = No NOTE: Additional visit required by protocol if mean systolic is ≥ 140 mmHg. 10.A. If yes, scheduled visit date: __ __ /__ __ /__ __ __ __ MM DD YYYY

11. Weight:

11.A. Unit: 1= Pounds 2=Kilograms 11.B. Weight: .




LIFESTYLE INTERVENTION

12. Is the patient still being counseled by INTERxVENT? 1 = Yes 2 = No 12.A. If no, indicate reason: 1 = Patient refused 2 = Unable to contact 3 = Other Specify:_____________________________________________________________

13. Current tobacco use? (Regular use of cigarettes, cigars, chewing tobacco or pipes within past year.)


14. Past tobacco use? (Regular use of cigarettes, cigars, chewing tobacco or pipes prior to the past year.)


15. Current smoking status: (Select only one response.)

1 = I never smoked.

2 = I smoke now, and I don’t intend to quit within the next 6 months. 15.B.1. How many cigarettes do you smoke a day? _____ cigarettes

3 = I smoke now, but I have been thinking of quitting soon. 15.C.1 How many cigarettes do you smoke a day? _____ cigarettes

4 = I’m trying to quit, but I have frequent slips. 15.D.1. How many cigarettes do you smoke a day? _____ cigarettes

5 = I quit smoking 1-6 months ago and have stayed quit.

6 = I quit smoking 7 or more months ago and have stayed quit. 16. How often do you have a drink containing alcohol? 1=Never 2=Monthly or less 3=2 to 4 times a month 4=2 to 3 times a week 5=4 or more times a week -9=Unknown




17. Current physical activity status: (Select only one response.) This form will help your health care provider understand your level of physical activity. Please read the entire form and then choose the ONE number below that best describes your current level of physical activity or your readiness to do more physical activity. Do not include activities you do as part of your job. “Vigorous” exercise includes activities like jogging, running, fast cycling, aerobics classes, swimming laps, singles tennis, and racquetball. Any activity that makes you work as hard as jogging lasts 20 minutes at a time should be counted. These types of activities usually increase your heart rate, and make you sweat, and you get out of breath. (Do not count weight lifting.) Regular vigorous exercises is done for at least 20 minutes at a time and at least 3 days a week. “Moderate” exercise includes activities like brisk walking, gardening, slow cycling, dancing, doubles tennis, or hard work around the house. Any activity that makes you work as hard as brisk walking and that lasts at least 10 minutes at a time should be counted. Regular moderate exercise is done at least 30 minutes a day and at least 5 days a week.

1 = I don’t do regular vigorous or moderate exercise now, and I don’t intend to start in the

next 6 months.

2 = I don’t do regular vigorous or moderate exercise now, but I have been thinking of starting in the next 6 months.

3 = I’m trying to start doing vigorous or moderate exercise, but I don’t do it regularly (i.e. weekly).

4 = I’m doing vigorous exercise regularly but less than 3 times per week (or) moderate exercise regularly but less than 5 times per week.

5 = I’ve been doing 30 minutes a day of moderate exercise 5 or more days per week for the last 1-5 months.

6 = I’ve been doing 30 minutes a day of moderate exercise 5 or more days per week for the last 6 months or more.

7 = I’ve been doing vigorous exercise 3 or more days per week for the last 1-5 months.

8 = I’ve been doing vigorous exercise 3 or more days per week for the last 6 months or more.




INTERVAL MEDICAL HISTORY

Has the patient had any of the following since the last CREST-2 contact by phone or in person?

18. Has the patient been newly diagnosed with hypertension?

(If yes at 1-month visit, complete an Adverse Event form [F26].)

1 = Yes 2 = No

19. Has the patient been newly diagnosed with diabetes mellitus?


1 = Yes 2 = No

20. Has the patient been newly diagnosed with hyperlipidemia?


1 = Yes 2 = No

21. Has the patient been newly diagnosed with atrial fibrillation?


1 = Yes 2 = No

22. Has the patient reported to the Emergency Department for any

reason? (If yes, complete an Adverse Event form [F26], if needed.)

1 = Yes 2 = No

23. Has the patient been hospitalized?

(If yes, complete an Adverse Event form [F26], if needed.)

1 = Yes 2 = No

24. Has a physician told the patient that s/he had a heart attack?


1 = Yes 2 = No

25. Has the patient had any cardiac revascularizations, including

catheterization? (If yes at 1-month visit, complete an Adverse Event form [F26].)

1 = Yes 2 = No

26. Has a physician told the patient that s/he had a stroke?

(If yes, complete an Adverse Event form [F26] and a Stroke/TIA Event form [F27].)

1 = Yes 2 = No




INTERVAL MEDICAL HISTORY (cont.)

27. Has the patient had a new brain CT or MRI?

(if yes, complete a Site Parenchymal Imaging form [F19].) 27.A. If yes, indicate new tests done: (Check all that apply.)

27.B. Did the test(s) show a new infarct or hemorrhage?

1 = Yes

1 = CT

1 = Yes

2 = No

1 = MRI

2 = No

28. Has the patient had any new focal neurologic symptoms? (If yes, complete an Adverse Event form [F26] and a Stroke/TIA Event form [F27].)

1 = Yes

2 = No

29. Has the patient had any carotid revascularizations?

(If yes, complete an Adverse Event form [F26] and a Carotid Revascularization form [F31].)

1 = Yes

2 = No

30. Has the patient had any symptoms of postural hypotension or

syncope? (If yes, check standing blood pressure and record on Question 6 of this form; complete an Adverse Event form [F26].)

1 = Yes

2 = No

31. Has the patient had any other symptoms attributable to blood

pressure medications? 31.A. If yes, specify:_____________________________________ (If yes, complete an Adverse Event form [F26].)

1 = Yes 2 = No

32. Has the patient had any myopathic symptoms?

(If yes, complete an Adverse Event form [F26].)

1 = Yes 2 = No

33. Any other new adverse events to report since the last visit?

33.A. If yes, specify: _______________________________________ (If yes, complete an Adverse Event form [F26].)

1 = Yes

2 = No


Carotid Artery Stent Procedure v2.0 (01.27.15)

CREST-2 Page 1 of 13


FORM 14 CAROTID ARTERY STENT (CAS) PROCEDURE

Instructions:

Please complete this form for each patient randomized to undergo carotid stenting.

1. Date of form completion: __ __ /__ __ /__ __ __ __ MM DD YYYY

PROCEDURAL DETAILS

2. Target artery: 1= Right 2=Left

3. Was a CAS procedure initiated? 1=Yes 2=No

3.A. If yes, date of procedure: ___ ___ /___ ___ /___ ___ ___ ___ MM DD YYYY

3.B. If no, select one and END FORM:

1=Patient refuses assigned treatment after randomization.

2=Other Specify: ___________________________________________________

4. If a CAS procedure was initiated, was a stent placed? 1=Yes 2=No

(NOTE: The reasons for not placing the stent will be queried on the form below.)

ANGIOGRAPHY FINDINGS

5. Was an angiogram preformed as part of the CAS procedure? 1=Yes 2=No

5.A. If yes, date of angiogram: ___ ___ /___ ___ /___ ___ ___ ___ MM DD YYYY





6. Target lesion minimal residual lumen: ___ . ___mm (a)

7. Reference diameter (internal carotid distal to target lesion at point when artery walls return to parallel): ___ ___ . ___mm (c)

8. Target lesion % diameter stenosis: ___ ___ ___ % Formula: (1 – [a/c]) x 100. Round answer down to the nearest whole percent.

9. Target lesion length: ___ ___ mm

Lesion Treatment

10. Based on the angiogram, was a decision made to continue with stenting? 1=Yes 2=No

If yes,

10.A. Time procedure began (arterial puncture): ___ ___ : ___ ___ (24 hr. format)

10.B. Time of embolic protection device placement: ___ ___ : ___ ___ (24 hr. format)

(NOTE: Enter 99:99 if no embolic protection device was used.)

10.C. Time of embolic protection device removal: ___ ___ : ___ ___ (24 hr. format)

(NOTE: Enter 99:99 if no embolic protection device was used.)

10.D. Time procedure ended (last cath removed): ___ ___ : ___ ___ (24 hr. format)

10.E. Total fluoroscopy time: ___ ___ (minutes)





If no,

10.F. Provide primary reason to not continue with stenting: (Select one)

1=Degree of carotid stenosis was below 70% and deemed not appropriate for stenting. 2=Angiographic evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries. 3=Type III, aortic arch anatomy. 4=Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement.

5=Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis. 6=Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than stenosis of index lesion. 7=Excessive circumferential calcification of the stenotic lesion defined as > 3mm thickness of calcification seen in orthogonal views on fluoroscopy. 8=Target ICA vessel reference diameter < 4.0 mm or > 9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used. 9=Ipsilateral internal or common carotid artery occlusion. 10=Intra-carotid floating thrombus. 11=Ipsilateral intracranial aneurysm > 5mm. 12=Contralateral common or internal carotid artery occlusion. 13=Non-contiguous lesion and long lesions > 3 cm. 14=Inability to deploy or utilize a FDA-approved Embolic Protection Device (EPD).

15=Other, Specify: ________________________________________________

If the answer to Question 10 is “No” and Question 10.F has been completed, do not complete the rest of this form.

Follow patient per protocol and submit all other baseline and follow-up forms.





11. Was patient on daily Aspirin at least 2 days prior to the procedure? 1=Yes 2=No

If yes,

11.A. Indicate dosage: ___ ___ ___ mg/day (Skip to Question 12.)

If no,

11.B. Did patient receive a loading dose of Aspirin (325 mg) at least 4 hours pre-procedure?

1=Yes 2=No

12. Was patient on an antiplatelet other than Aspirin at least 2 days prior to the procedure?

1=Yes 2=No

If yes,

12.A. Select one antiplatelet from the list below and provide dosage:

1=Clopidogrel Dosage: ___ ___ mg/day

2=Ticlopidine Dosage: ___ ___ ___ mg/day

3=Prasugrel Dosage: ___ ___ mg/day

4=Ticagrelor Dosage: ___ ___ ___ mg/day

5=Other Specify: Dosage: ___________ Unit: ____________ If no,

12.B. Did patient receive a loading dose of an antiplatelet other than Aspirin at least 4 hours pre- procedure? 1=Yes 2=No

If yes,

12.B.1. Select one antiplatelet from the list below and provide the loading dose:

1=Clopidogrel Loading dose: ___ ___ ___ mg

2=Ticlopidine Loading dose: ___ ___ ___ mg

3=Prasugrel Loading dose: ___ ___ ___ mg

4=Ticagrelor Loading dose: ___ ___ ___ mg

5=Other Specify: _______ Dosage: ________ Dosage: _________ Unit: ________

NOTE: Note: Patients must be on pre-treatment aspirin (Q.11), or have an aspirin loading dose (Q.11.B), or have an antiplatelet treatment (Q.12), or an antiplatelet loading dose (Q.12.B). If no to all of these questions, please complete a Protocol Deviation form (F22).





13. Was patient given an extra loading dose (80 mg) of atorvastatin or equivalent dose of other statin within 24 hours prior to the procedure?

1=Yes 2=No

14. Was dilation with a balloon angioplasty required prior to embolic protection device placement?

1=Yes 2=No

15. Was an embolic protection device placed? 1=Yes 2=No

If yes,

15.A. Name of device?

1=RX Accunet filter 2= Emboshield Nav6 filter 3= FilterWire EZ Embolic Protection 4= ANGIOGUARD™ Emboli Capture Guidewire 5= Mo.Ma Ultra Proximal Cerebral Device

15.A.1 Total number of embolic protection devices opened: 1=1 2= 2

If no, select a reason below:

15.B. Inability to safely cross the lesion with a protection device? 1=Yes 2= No

15.C. Other reason? 1=Yes 2= No

If yes, specify: _________________________________

15.D Embolic Protection Device Packaging: (Enter device information from package labels.)

Embolic Protection Device One

15.D.1 Name of Embolic Device: _______________________________________ 15.D.2 Serial #: _____________________________________________________ 15.D.3 Ref #: _______________________________________________________ 15.D.4 Diameter: ___ . ___ mm 15.D.5 Was device opened, but not used? 1=Yes 2=No




FORM 14 CAROTID ARTERY STENT ( CAS) PROCEDURE

Embolic Protection Device Two

15.D.6 Name of Embolic Device:________________________ 15.D.7 Serial #: ______________________________________ 15.D.8 Ref #: _______________________________________ 15.D.9 Diameter: ___ . ___ mm 15.D.10 Was device opened, but not used? 1=Yes 2=No

16. Was the embolic protection device used during the entire procedure? 1=Yes 2=No

If yes, skip to Question 17.

If no, select all that apply AND complete an Embolic Protection Device and Stent Treatment Failure form (F29):

1=Failure to deliver stent over the embolic protection device

1= Filter thrombosis

1= Arterial dissection

1= Other Specify: _______________________________________________________________

17. Was dilation with balloon angioplasty required prior to stent deployment? 1=Yes 2=No

Stent Deployment

18. Total number of stents opened: 1=1 2=2 3=3

18.A. Was a stent successfully deployed? 1=Yes 2=No

If no, complete Embolic Protection Device and Stent Treatment Failure Form (F29), and skip to Question 29.





STENT ONE

18.B. Name of Stent: ______________________________________

18.C. Serial #: ___________________________________________

18.D. Ref #: _____________________________________________ 18.E. Length (mm): 20=20 30=30 40=40

18.F. Diameter (mm):

5= 5 6=6 7=7 8=8 9= 9 10=10 68= 6-8 Taper 710=7-10 Taper

18.G. Was a second stent used? 1=Yes 2=No If no, skip to Question 19.

If yes, select all that apply:

18.G.1. 1=First stent was opened, but not used

1=Stent was not correctly positioned

1=Entire lesion was not covered by the stent

1=Stent malfunctioned

1=Other Specify:





STENT TWO

18.H. Name of Stent: ______________________________________ 18.I. Serial #: ___________________________________________ 18.J. Ref #: _____________________________________________ 18.K. Length (mm): 20=20 30=30 40=40 18L. Diameter (mm): 5=5 6=6 7=7 8=8 9= 9 10=10 68= 6-8 Taper 710=7-10 Taper 18.M. Location of second stent: 1=Proximal to stent #1 2=Distal to stent #1 18.N. Relationship to stent #1: 1=Tandem with overlap 2=Abutting 3=Separate (<5mm) 18.O. Was a third stent used? 1=Yes 2=No If no, skip to Question 19. If yes, select all that apply: 18.O.1. 1=Second stent was opened, but not used 1=Stent was not correctly positioned 1=Entire lesion was not covered by the stent 1=Stent malfunctioned 1=Intentional use for long lesion 1=Stabilize dissection/lesion due to stent #1 1=Other Specify:





STENT THREE

18.P. Name of Stent: ______________________________________ 18.Q. Serial #: ___________________________________________ 18.R. Ref #: _____________________________________________ 18.S. Length (mm): 20=20 30=30 40=40 18.T. Diameter (mm):

5=5 6=6 7=7 8=8 9= 9 10=10 68= 6-8 Taper 710=7-10 Taper

18.U. Location of third stent: 1=Proximal to stent #1 and #2 2=Distal to stent #1 and #2

18.V. Relationship to stent #1 and #2: 1=Tandem with overlap 2=Abutting 3=Separate (<5mm) 18.W. Did the third stent malfunction? 1=Yes 2=No 19. Post-stent balloon dilation performed? 1=Yes 2=No

20. Final target lesion minimal residual lumen (RL): ___ . ___ mm (a) (RL post procedure refers to narrowest diameter within stent.)





21. Final reference diameter (internal carotid distal to target lesion at point when artery walls return to parallel): ___ ___ . ___ mm(c) 22. Target lesion final % diameter stenosis: ___ ___ ___% (Formula: (1 – [ a/c]) x 100) NOTE: Round answer down to the nearest whole percent. 23. Final TICI (Thrombolysis in Cerebral Infarction) flow: 0=TICI 0 1=TICI 1 2=TICI 2a 3=TICI 2b 4=TICI 3 24. Total length of stented segment: ___ ___ mm

TICI Flow:

TICI 0 – No perfusion. TICI 1 – Perfusion past the initial obstruction, but limited distal branch filling with little or slow distal perfusion. TICI 2a – Partial perfusion of less than ½ of the vascular distribution of the occluded artery (i.e., filling and perfusion in 1 M2 division). TICI 2b – Partial perfusion of ½ or greater of the vascular distribution of the occluded artery (i.e., filling and perfusion in 2 or more M2 segments). TICI 3 – Full perfusion with filling of all distal branches.

25. Did patient have hypotension during the procedure requiring pharmacologic treatment?

1=Yes 2=No

POST PROCEDURAL DETAILS 26. Did patient receive IV antihypertensives within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No

27. Did patient have hypotension requiring pharmacologic treatment within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No

28. Did the patient have a wound complication (e.g., significant bleeding requiring blood transfusion or return to the operating room or both, significant hematoma requiring blood transfusion or return to the operating room or both) within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No If yes, complete an Adverse Event Form (F26) and a Bleeding/ Vascular Complication Form (F30).





POST PROCEDURAL DETAILS (cont.) 29. Did patient demonstrate a new neurologic deficit(s) within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No

If yes, complete an Adverse Event form (F26) and a Stroke/TIA Event Form (F27).

30. Did patient return to procedure room in this admission? 1=Yes 2=No

30.A. If yes, reason for return: (Select all that apply.)

1=Post-operative stroke/TIA

1=Operative site bleeding

1=Other Specify:

If yes, complete an Adverse Event form (F26) AND a Stroke/TIA Event form (F27) OR a Bleeding Vascular Complication form (F30).

31. Did the patient develop any other complication (e.g., myocardial infarction, congestive heart failure, respiratory infection, respiratory failure, renal insufficiency, death) within 24 hours after the procedure or time of discharge if earlier than 24 hours)?

1=Yes 2=No

If yes, complete an Adverse Event form (F26).

32. Type of procedural anticoagulation used: (NOTE: Required for procedure; select all that apply, but must select at least one.) 1=Heparin dose: ___ ____ ___ ___ ___ IU

If heparin was used, please also provide:

32.A Maximum ACT during procedure: Time: ___ ___ : ___ ___ (24 hr) Value: ___ ___ ___ (sec)

1=Angiomax (Bivalirudin) dose: Bolus ___ ___ ___mg OR Infusion ___ ___ ___ mg

1=Other Specify: Dose: _______________ Unit: _________

(NOTE: If no procedural anticoagulation is selected, please complete a Protocol Deviation form [F22].)





33. Was atropine used during the procedure? 1=Yes 2=No

34. Did patient require pacing during the procedure? 1=Yes 2=No

If yes,

34.A. Temporary pacemaker? 1=Yes 2=No

34.B. Permanent pacemaker? 1=Yes 2=No

35. Did patient require pacing post procedure (within 12 hours of the procedure)?

1=Yes 2=No

If yes, answer questions below and complete an Adverse Event form (F26). 35.A. Temporary pacemaker 1=Yes 2=No

35.B. Permanent pacemaker 1=Yes 2=No

36. Intraoperative complications? 1=Yes 2=No

If yes, complete an Adverse Event form (F26).

36.A. If yes, select all that apply:

1=Pacemaker 1=Blood transfusion 1=Arterial dissection 1=Arterial thrombosis 1=Primary stent thrombosis 1=Primary anti-embolic protection device malfunction (Complete an Embolic Protection Device and Stent Failure form [F29].)

1=Stent malfunction (Complete an Embolic Protection Device and Stent Failure form [F29].)





Post-Procedure Monitoring

37. Was a thrombolytic agent IIb/IIIa antagonist used? 1=Yes 2=No

NOTE: These agents are prohibited except for bail-out.

38. Blood Pressure Monitoring

38.A. Did the patient have hypertension requiring treatment (within 12 hours of the procedure)?

1=Yes (Complete an Adverse Event form [F26].) 2=No -9=Unknown

38.B. Did the patient have hypotension requiring treatment (within 12 hours of the procedure)?

1=Yes (Complete an Adverse Event form [F26].) 2=No -9=Unknown

39. Print name of interventionalist : ________________________________________________

39.A. Interventionalist Code: ___ ___ ___

Carotid Endarterectomy Procedure v1.0 (11.24.14)


FORM 15 CAROTID ENDARTERECTOMY (CEA) PROCEDURE

Instructions:

Please complete this form for each patient randomized to undergo carotid endarterectomy.


2. Target artery: 1=Right 2=Left

3. Was lesion treated with CEA? 1=Yes 2=No

If yes, skip to Question 4. If no, please complete a Protocol Deviation form (F22) and answer question 3.A. 3.A. Check one reason: 1=Patient refuses assigned treatment after randomization. 2=Patient determined to be ineligible for CEA after randomization. Specify why ineligible: _____________________________________________

3=Other Specify: _____________________________________________________

If answer to Question 3 is “No” and Question 3.A. has been completed,

do not complete the rest of this form. Follow patient per protocol and submit all other required follow-up forms.

4. Was patient on daily Aspirin at least 2 days prior to the procedure? 1=Yes 2=No

If yes,

4.A. Indicate dosage: __ __ __ mg/day (Skip to Question 5.)

If no,

4.B. Did patient receive a loading dose of Aspirin (325 mg) at least 4 hours pre-procedure?

1=Yes 2=No


CREST-2 Page 2 of 6


FORM 15 CAROTID ENDARTERECTOMY (CEA) PROCEDURE

PRE-PROCEDURAL DETAILS

5. Was patient on an antiplatelet other than Aspirin at least 2 days prior to the procedure?

1=Yes 2=No

If yes,

5.A. Select one antiplatelet from the list below and provide dosage:

1=Clopidogrel Dosage: ___ ___ mg/day 2=Ticlopidine Dosage: ___ ___ ___ mg/day 3=Prasugrel Dosage: ___ ___ mg/day 4=Ticagrelor Dosage: ___ ___ ___ mg/day 5=Other Specify: Dosage: _________ Unit: _________

If no,

5.B. Did patient receive a loading dose of an antiplatelet other than Aspirin at least 4 hours pre-procedure? 1=Yes 2=No

If yes,

5.B.1. Select one antiplatelet from the list below and provide the loading dose:

1=Clopidogrel Loading dose: ___ ___ ___ mg 2=Ticlopidine Loading dose: ___ ___ ___ mg 3=Prasugrel Loading dose: ___ ___ ___ mg 4=Ticagrelor Loading dose: ___ ___ ___ mg 5=Other Specify: Dosage: _________ Unit: _______

Note: Patients must be on pre-treatment aspirin (Q.4), or have an aspirin loading dose (Q.4.A), or have an antiplatelet treatment (Q.5), or an antiplatelet loading dose (Q.5.A). If no to all of these questions, please complete a Protocol Deviation form (F22).



FORM 15 CAROTID ENDARTERECTOMY PROCEDURE

PRE-PROCEDURAL DETAILS (continued)

6. Was patient given an extra loading dose (80 mg) of atorvastatin or equivalent dose of other statin within 24 hours prior to procedure?

1=Yes 2=No

PROCEDURAL DETAILS

7. Date of procedure: __ __ /__ __ /__ __ __ __ MM DD YYYY

8. Time procedure began (incision time): ___ ___ : ___ ___ (24 hr. format)

9. Time procedure ended (skin closure time): ___ ___ : ___ ___ (24 hr. format)

10. Indicate type of anesthesia given: 1=General 2=Regional Block 11. Type of procedural anticoagulation used: (Required for procedure; please select all that apply, but

at least one must be selected.) 1=Heparin dose: ___ ___ ___ ___ ___ IU 1=Angiomax (Bivalirudin) dose: ___ ___ ___ mg 1=Other Specify: Dose: Unit: ____________

Note: If no anticoagulation was used, please complete a Protocol Deviation form (F22).

12. Was anticoagulation reversed at the end of the case? 1=Yes 2=No 12.A. If yes, Protamine: ___ ___ ___ mg

13. Type of endarterectomy performed:

1=Anterior arteriotomy

2=Eversion

3=Other Specify (e.g., interposition graft):


CREST-2 Page 4 of 6



PROCEDURAL DETAILS (continued)

14. Was a patch used? 1=Yes 2=No

14.A. If yes, check the one response that applies:

1=Prosthetic Dacron patch

2=Prosthetic PTFE patch

3=Saphenous vein patch

4=Neck vein patch

5=Other Specify: _________________________________________________________

15. Was a shunt used? 1=Yes 2=No

16. Was cerebral collateral circulation assessed? 1=Yes 2=No

16.A. If yes, check all that apply:

1=Patient awake (e.g., squeeze toy, verbal communication)

1=Evoked potentials

1=Back bleeding from ICA

1=ICA stump pressure

1=EEG

1=Other Specify: __________________________________________________________

17. Were intraoperative antihypertensives administered? 1=Yes 2=No

18. Were intraoperative pressors administered? 1=Yes 2=No

19. Was intraoperative blood transfusion administered? 1=Yes 2=No

20. Did the patient have intraoperative assessment of the repair? 1=Yes 2=No

20.A. If yes, check all that apply.

1=Angiography

1=Duplex ultrasound

1=Other Specify: __________________________________________________________


CREST-2 Page 5 of 6



POST PROCEDURAL DETAILS 21. Did patient receive IV antihypertensives within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No

22. Did patient have hypotension requiring pharmacologic treatment within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No

23. Did the patient have a wound complication (e.g., significant bleeding requiring blood transfusion or return to the operating room or both, significant hematoma requiring blood transfusion or return to the operating room or both) within 24 hours after the procedure or time of discharge (if earlier than 24 hours)?

1=Yes 2=No

If yes, complete Adverse Event form (F26) AND Bleeding/Vascular Complication form (F30).

24. Did patient demonstrate a new neurologic deficit(s) within 24 hours after the procedure or time of discharge (if earlier than 24 hours)? 1=Yes 2=No

24.A. If yes, new neurologic deficits: (Check all that apply.)

1=Potential stroke/TIA

1=Cranial nerve palsy (Check all that apply.)

1=Hypoglossal

1=Vagus

1=Glossopharyngeal

1=Other Specify: _________________________________________________________

If yes, complete the Adverse Event form (F26) AND the Stroke/TIA Event form (F27) OR the Cranial Nerve Palsy form (F28).

25. Did patient return to operating room in this admission? 1=Yes 2=No

25.A. If yes, reason for return: (Check all that apply.)

1=Post-operative stroke/TIA

1=Operative site bleeding

1=Other Specify:

If yes, complete the Adverse Event form (F26) AND the Stroke/TIA Event Form (F27) OR the Bleeding/Vascular Complication Form (F30).


CREST-2 Page 6 of 6



POST PROCEDURAL DETAILS (continued)

26. Did the patient develop any other complication (e.g., myocardial infarction, congestive heart failure, respiratory infection, respiratory failure, renal insufficiency, death) within 24 hours after the procedure or time of discharge (if earlier than 24 hours)?

1=Yes 2=No

If yes, complete an Adverse Event Form (F26).

27. Print name of surgeon: ______________________________________________________________

27.A. Surgeon Code: ___ ___ ___

Post-Procedure Hospital Discharge v1.0 (11.24.14)

CREST-2 Page 1 of 1

PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ____ ____ ____ ____ ____

SITE ID SITE ID

FORM 16

POST- PROCEDURE HOSPITAL DISCHARGE

1. Date of hospital admission: __ __ /__ __ /__ __ __ __

MM DD YYYY

2. Date of hospital discharge: __ __ /__ __ /__ __ __ __ MM DD YYYY

3. Patient was discharged to: (Select one.) 1=Home 2=Rehabilitation 3=Skilled nursing facility 4=Assisted living facility 5=Death 9=Other Specify: ___________________________________________________________

4. Was the NIH Stoke Scale completed 12-36 hours post-procedure?

1 =Yes

2 = No

5. Was the medication form updated with discharge

medications?

1 =Yes

2 = No

6. Has the 30-day visit been scheduled?

1 =Yes

2 = No

_____________________________________________ Signature of Principal Investigator (PI)

7. PI Code: ___ ___ ___

8. Signature date: __ __ /__ __ /__ __ __ __ MM DD YYYY

Site Duplex Ultrasound v1.0 (11.24.14)

CREST-2 Page 1 of 4 PID1: ___ ___ ___ - ___ ___ ___ ___ SITE ID

PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID

FORM 17 SITE DUPLEX ULTRASOUND

Instructions: This form is to be completed by the clinical center vascular lab. The associated images of the duplex ultrasound study must be transferred electronically to the Vascular Imaging Core Laboratory at the University of Maryland using their File Transfer Protocol (FTP) site or must be saved on a CD/DVD and mailed to them.

1. Visit date: __ __ /__ __ /__ __ __ __

MM DD YYYY

2. Visit:

1 = Baseline 2 = 1 year follow-up 3 = 2 year follow-up 4 = 3 year follow-up 5 = 4 year follow-up

Unscheduled visit: 6 = Post-stroke 7 = Post re-intervention 9 = Other Specify: __________________________________________________

3. Was an ultrasound performed? 1=Yes 2=No

3.A. If yes, date performed: __ __ /__ __ /__ __ __ __ MM DD YYYY

4. Ultrasonographer Code: ___ ___ ___

5. Name of machine: ________________________________________________

5.A. Transducer type (e.g., L9-3): __________ MHz

6. Target Artery: 1=Right 2=Left



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID

FORM 17 SITE DUPLEX ULTRASOUND FORM

7. For each location, mark whether Doppler waveforms were evaluated and recorded. Please provide

the highest result for each of the following measures for both the right and left internal carotid artery (ICA) and common carotid artery (CCA) for each location.

RIGHT

VELOCITY LOCATIONS

LEFT

Doppler waveform evaluated

and recorded

Peak Systolic Velocity (cm/s)

End Diastolic Velocity (cm/s)

Doppler waveform

evaluated and recorded

Peak Systolic Velocity (cm/s)

End Diastolic Velocity (cm/s)

=1 __ __ __ __ __ __ Distal ICA =1 __ __ __ __ __ __

=1 __ __ __ __ __ __ Middle ICA =1 __ __ __ __ __ __

=1 __ __ __ __ __ _ Proximal ICA =1 __ __ __ __ __ __

=1 __ __ __ __ __ __ Distal CCA =1 __ __ __ __ __ __

=1 __ __ __ __ __ __ Middle CCA =1 __ __ __ __ __ __

=1 __ __ __ __ __ __ Proximal CCA =1 __ __ __ __ __ __

ICA/CCA Ratio __ __ . __ 00.1-20.0 ICA/CCA Ratio __ __ . __

Stenosis category: __ __ __- __ __ __% Enter hyphen with no spaces.

0-100% Stenosis category: __ __ __- __ __ __ % Enter hyphen with no spaces.

7.A. If Doppler waveforms were NOT evaluated and recorded, please indicate at which location (s) AND the reason for each: ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________________________________ 7.B. Are angles 60° or 0°?

1=Yes 2=No Specify reason:_____________________________________________________________



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID


8. Did patient receive a stent? 1=Yes 2=No

If this is a baseline visit or patient did not receive a stent, skip to Question 9.

If yes, please provide location (from to) of stent:

8.A.1. From: 1=Distal CCA 2=Proximal ICA 8.A.2. To: 1=Proximal ICA

2=Mid ICA 3=Distal ICA

8.B. Were Doppler waveforms for proximal, middle, and distal stent documented? 1=Yes 2=No If no, specify reason: _____________________________________

9. Was a longitudinal view of the plaque recorded in: 9.A. B-mode? 1=Yes 2=No If no, specify reason: ___________________________ 9.B. Color Flow Mode? 1=Yes 2=No If no, specify reason: ___________________________ 9.C. Power Doppler? 1=Yes 2=No If no, specify reason: ___________________________ (or equivalent mode)

10. Additional Comments: 1=Yes 2=No _________________________________________________________________________________ _________________________________________________________________________________

__________________________________________________________________________________ __________________________________________________________________________________ ___________________________________________________________________________________



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID


11. Please select method of image transfer to University of Maryland:

1= File transfer protocol site 11.A. Date of transfer: __ __ /__ __ /__ __ __ __

MM DD YYYY

2= Courier service 11.B. Specify courier: ________________________________________ 11.C. Date of shipment: __ __ /__ __ /__ __ __ MM DD YYYY

11.D. Tracking number: _________________________

Laboratory Results v2.0 (01.27.15)


FORM 18 LABORATORY RESULTS

Schedule of Protocol-Required Laboratory Tests: Baseline: Creatinine, Potassium, AST/ALT, HgA1c, CK, Total Cholesterol, HDL, LDL, Triglycerides 1 month visit: Total Cholesterol, HDL, LDL, Triglycerides 12, 24, 36, 48 month visits: Creatinine, Potassium, Total Cholesterol, HDL, LDL , Triglycerides

Results obtained within 90 days prior to randomization, +/- 7 days of the 1-month visit, +/- 30 days of the 4-

month visit, +/- 60 days of the 8- through 48-month visits are acceptable. 1. Visit date: __ __ /__ __ /__ __ __ __

MM DD YYYY

2. Visit: _______________

3. Was the blood for all laboratory tests drawn on the same date?

1 =Yes 2 = No 3 = No labs done 3.A. If yes, record date: __ __ /__ __ /__ __ __ __

MM DD YYYY

If yes, do NOT record dates for each individual laboratory test. If no, record individual dates for each laboratory test. If visit-specific labs not done (see above and page 4), complete a Protocol Deviation form (F22).

BLOOD TEST RESULTS

4. Creatinine: 1=Done 2=Not Done

4.A. . mg/dl OR . mmol/L 4.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY

5. Potassium: 1=Done 2=Not Done

5.A. . mEq/L OR . mmol/L 5.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY

6. AST (SGOT): 1=Done 2=Not Done

6.A. IU/L OR . µkat/L 6.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY



FORM 18 LABORATORY RESULTS BLOOD TEST RESULTS (cont.)

7. ALT (SGPT): 1=Done 2=Not Done

7.A. U/L OR . µkat/L 7.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY

8. CK: 1=Done 2=Not Done

8.A. U/L OR . µkat/L 8.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY

9. Total Cholesterol: 1=Done 2=Not Done

9.A. mg/dL OR . mmol/L 9.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY

10. HDL: 1=Done 2=Not Done


11. LDL: 1=Done 2=Not Done


12. VLDL: 1=Done 2=Not Done


13. Triglycerides: 1=Done 2=Not Done





BLOOD TEST RESULTS (cont.)

14. Was patient fasting for at least 8 hours prior to the lipid profile?


15. Hemoglobin A1c: 1=Done 2=Not Done

15.A. . mmol/L OR mmol/mol 15.B. Date of draw: __ __ /__ __ /__ __ __ __ MM DD YYYY

16. Were any changes to medications made based on the above laboratory results?

1 =Yes 2 = No

If yes, which medication(s) was (were) changed? If yes to any below, update Medications form (F08).

16.A. Lipid lowering therapy 1 =Yes 2 = No

16.B Hypertension therapy 1 =Yes 2 = No

16.C. Diabetic therapy 1 =Yes 2 = No

16.D. Other 1 =Yes 2 = No If “Other”, specify: ___________________________________________________





Schedule of Laboratory Tests Required for Intensive Medical Management

Laboratory Test* Scheduled PRN

Creatinine (Cr) Potassium (K)

• Baseline • Annually

If on ACE inhibitor: Cr and K 30 days after starting or

changing dose If on diuretic:

K 30 days after starting or changing doseIf on spironolactone:

K 30 days after starting or changing dose Local Lipid • Baseline (within 90 days prior to

enrollment) • 30 days • Annually

- If not in target at 30 day repeat at 4 month visit

AST/ALT • Baseline • If > 3x normal, repeat in 1 wk • As clinically indicated

CK • Baseline • If patient develops symptoms of statin toxicity

HgA1c┼

• Baseline (all patients) • Every 6 months┼ (only if diabetic)

• If patient not meeting treatment goals or if change in therapy

- quarterly

*All tests may be performed at any qualified laboratory. With the exception of the hemoglobin A1c, all tests should be ordered by study physician managing the patient’s blood pressure and statin medications. ┼Study physician should ensure that patient’s primary care physician or diabetologist are following these ADA recommendations for evaluating the HgA1c.

Site Parenchymal Imaging v1.0 (11.24.14)


PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID

FORM 19

SITE PARENCHYMAL IMAGING Instructions: Please complete one form per imaging modality.

1. Date of study: __ __ /__ __ /__ __ __ __ 1.A. Time of study: : (24 hr format) MM DD YYYY

2. Date study sent to Mayo (Rochester) for review: __ __ /__ __ /__ __ __ __ MM DD YYYY

3. Imaging technician code: ___ ___ ___

4. Imaging modality: 1=MRI 2=CT

5. Chronic infarct: 1=Present 2=Equivocal 3=Absent

6. Acute infarct: 1=Present 2=Equivocal 3=Absent

7. Hemorrhage: (Select all that apply.)

1=None 1=Subarachnoid hemorrhage 1=Intraparenchymal 1=Intraventricular 1=Epidural 1=Acute subdural 1=Chronic subdural 1=Hemosiderin foci/chronic microbleeds

8. Hydrocephalus: 1=Present 2=Equivocal 3=Absent

9. Additional findings: (Select all that apply.)

1=None 1=Vasogenic edema 1=Focal mass lesion 1=Aneurysm 1=Arteriovenous malformation 1=Other Specify: _________________________________________________________________

Central Parenchymal Imaging v1.0 (11.24.14)


PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID

FORM 20 CENTRAL PARENCHYMAL IMAGING

Instructions: Please complete one form per imaging modality. Refer to the key on page 6 for Questions 4 and 7.

1.A. Date of study: __ __ /__ __ /__ __ __ __ 1.B. Time of study: : (24 hr format) MM DD YYYY

2. Date study interpreted: __ __ /__ __ /__ __ __ __

MM DD YYYY

3. Imaging modality: 1=MRI 2=CT

4. Infarction: (Refer to key on page 6 for brain region, side, and hemorrhage classification.)

1=Yes 2=No (Skip to Question 6.)

4.A. If yes, total number of infarctions: ___ ___

Infarction

1=Acute, 2=Chronic

Brain

Region Side

Maximum Diameter (mm)

Hemorrhage

1=Yes, 2=No

Hemorrhage

Classification


CREST-2 Page 2 of 6 PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ___ ___ ___ ___ ___

SITE ID SITE ID


5. ASPECT Score (for acute infarction)

Segmental assessment of the following MCA territory:

5.A. C = caudate: 1=Yes 2=No

5.B. L = lentiform: 1=Yes 2=No

5.C. IC = internal capsule: 1=Yes 2=No

5.D. I = insular ribbon: 1=Yes 2=No

5.E. M1= anterior MCA cortex: 1=Yes 2=No

5.F. M2 = MCA cortex lateral to insular ribbon: 1=Yes 2=No

5.G. M3 = posterior MCA cortex: 1=Yes 2=No

5.H. M4 = anterior superior to M1, rostral to basal ganglia: 1=Yes 2=No

5.I. M5 = lateral superior to M2 rostral to basal ganglia: 1=Yes 2=No

5.J. M6 = posterior superior to M3, rostral to basal ganglia: 1=Yes 2=No Total Score: ___ ___ (Sum of items checked ‘Yes’ in 5.A. - 5.J above; range is 00 – 10.)

6. Leukoaraiosis:

Manolio White Matter Grade:

0 = No white matter findings

1 = Discontinuous periventricular rim with minimal dots of subcortical disease

2 = Thin, continuous periventricular rim with a few patches of subcortical disease

3 = Thicker, continuous periventricular rim with scattered patches of subcortical disease

4 = Thicker, shaggier periventricular rim with mild subcortical disease may have minimal

confluent periventricular lesions

5 = Mild periventricular confluence surrounding the frontal and occipital horns

6 = Moderate periventricular confluence surrounding the frontal and occipital horns

7 = Periventricular confluence with moderate involvement of the centrum semiovale

8 = Periventricular confluence involving most of the centrum semiovale

9 = Findings more remarkable than grade 8



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID


7. Intraparenchymal hematoma: (Refer to key on page 6 for brain region and side.)

1=Yes 2=No

7.A. If yes, number of intraparenchymal hematomas: ___ ___

Brain Region Side Maximum Diameter (mm)

8. Number of CT spot signs

0=None

1=1

2=2

3=3

4=N/A (not CT exam)

9. Microbleeds

0 = None

1 = 1 to 3

2 = 3 to 10

3 = Greater than 10



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID


10. Intraventricular hemorrhage (IVH) present: 1=Yes 2=No (If no, skip to Question 12.)

If yes, complete Graeb IVH Scale:

10.A. Right lateral ventricle score:

1 = Trace amount of blood or mild bleeding

2 = < Half of the ventricle filled with blood

3 = > Half of the ventricle filled with blood

4 = Ventricle expanded and filled with blood

10.B. Left lateral ventricle score:

1 = Trace amount of blood or mild bleeding

2 = < Half of the ventricle filled with blood

3 = > Half of the ventricle filled with blood


10.C. Third ventricle score:

1 = Blood present without dilatation


10.D. Fourth ventricle score:

1 = Blood present without dilatation


Total score: ___ ___ (Sum of scores 10.A. – 10.D.; range is 04-12.)

11. Intraventricular blood volume: ___ ___ cc

12. Subarachnoid hemorrhage (SAH) present: 1=Yes 2=No



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID


13. Modified Fisher Scale:

1=Grade 0: No SAH or IVH

2=Grade 1: SAH less than 1 mm thick, no IVH

3=Grade 2: SAH less than 1 mm thick, with IVH

4=Grade 3: SAH more than 1 mm thick, no IVH

5=Grade 4: SAH more than 1 mm thick, with IVH

14. Subdural hematoma present: 1=Yes 2=No (If no, skip to Question 15.)

If yes,

14.A. Type: 1=Mixed 2=Acute 3=Chronic

14.B. Location: 1=Right 2=Left 3= Bilateral

14.C. Thickness: ___ ___ mm

15. Epidural hematoma present: 1=Yes 2=No (If no, END FORM.)

If yes,

15.A. Location: 1=Right 2=Left 3=Bilateral

15.B. Thickness: ___ ___ mm



PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID


KEY FOR COMPLETING QUESTIONS 4 AND 7: Brain Regions

1 = Frontal lobe 2 = Parietal lobe 3 = Temporal lobe 4 = Occipital lobe 5 = Insula 6 = Cerebellum 7 = Pons 8 = Midbrain 9 = Medulla 10 = Corona radiata 11 = Anterior limb of the internal capsule 12 = Posterior limb of the internal capsule 13 = Caudate 14 = Globus pallidus 15 = Putamen 16 = Thalamus

Side 1= Right 2 = Left 3 = Midline

Hemorrhagic Transformation Classification 1 = None 2 = Laminar necrosis 3 = H1-1 (Hemorrhagic infarct type 1: small petechiae along the margins of the infarct) 4 = H1-2 (Hemorrhagic infarct type 2: more confluent petechiae within the infarct area but without space occupying effect) 5 = PH-1 (Primary intracerebral hemorrhage type 1: blood clot(s) NOT exceeding 30% of the infarct area with some mild space occupying effect) 6 = PH-2 (Primary intracerebral hemorrhage type 2: blood clots exceeding 30% of the infarct area with substantial space occupying effect) 7 = RPH-1 (Remote primary intracerebral hemorrhage type 1: small or medium sized blood clots located remote from the actual infarct; a mild space occupying effect could be present) 8 = RPH-2 (Remote primary intracerebral hemorrhage type 2: large confluent dense blood clots in an area remote from the actual infarct; substantial space occupying effect might be present) 9 = SAH (Subarachnoid hemorrhage) 10 = IVH (Intraventricular hemorrhage)

Blood Pressure Revisit v1.0 (11.24.14)


FORM 21

BLOOD PRESSURE REVISIT


CREST-2 BP MEASUREMENT PROTOCOL INSTRUCTIONS: 1. No caffeine or tobacco within prior 60 minutes. 2. Sitting position; “selected” arm relaxed and supported at level of the heart after 15 minutes of sitting quietly. 3. Select correct cuff size:


4. Minimize physical contact during measurement. 5. Take three readings separated by > 2 minutes. 6. Record the reading using the Omron electronic device. 7. Orthostatic (standing) measurements obtained after sitting BPs are measured, as indicated.


3. From what arm was blood pressure taken? 1=Right 2=Left (Note: Right arm preferred.) 4. Reading taken with (protocol is study device):

4.A. 1=Study device 2=Manual Cuff 3=Other, specify: ________________________ (Omron)




4.E. Mean of 3 readings, mmHg: / systolic diastolic (Note: Round down to nearest whole digit for the mean of 3 readings.)

Blood Pressure Revisit v1.0 (11.24.14)


FORM 21 BLOOD PRESSURE REVISIT

5. Heart rate: beats/min (Note: Record lowest heart rate reading from the above 3 blood pressure recordings.)

6. Standing blood pressure reading, mmHg: / systolic diastolic

Required at the following time points: 1. if patient reports orthostatic symptoms; and/or 2. if standing BP dropped > 15 mm Hg at last visit.

7. Was the study risk factor physician advised of above readings on the same day as required by the protocol?

1 = Yes 2 = No

7.A. If no, provide reason: ____________________________________________________________

8. Are the blood pressure medications being changed as a result of this visit?

1 = Yes 2 = No If yes, make the appropriate changes to the Medications form (F08). If the medication change was a diuretic or ACE inhibitor, the patient should have safety labs (potassium and creatinine) in 30 days. 8.A. If no and average SBP is >140, provide reason: (Check all that apply.)

1=SBP drop of > 15 when standing 1=Side-effects (Complete Adverse Event form [F26].)

1=Non-compliance 1=Other If other, specify reason: __________________________ 9. Coordinator Code: ___ ___ ___

Protocol Deviation v1.0 (11.24.14)


FORM 22 PROTOCOL DEVIATION

NOTE: Protocol deviations that are reportable within 24 hours are those that result in harm to the participant or have a > 50% likelihood of harming future participants. 1. Report date: __ __ / __ __ / __ __ __ __ MM DD YYYY

2. Protocol deviation date: __ __ / __ __ / __ __ __ __ MM DD YYYY

2.B. Visit:______________________________

3. This deviation is being reported because it could result in harm to the patient or has more than a 50% likelihood of harming future patients.

1=Yes

2=No

4. Did the deviation result in an Adverse Event?

1=Yes

2=No

If yes, complete an AE/ SAE form (F26).

5. Did the deviation result in a subject termination of study follow-up?

1=Yes

2=No

If yes, complete Study Termination/ Closeout form (F25).

6. Brief deviation description: _______________________________________________________________ _________________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________

Protocol Deviation v1.0 (11.24.14)

CREST- 2 Page 2 of 2 PID1: ___ ___ ___ - ___ ___ ___ ___ PID2: ___ ___ ___ - ___ ___ ___ ___ ___ SITE ID SITE ID

FORM 22 PROTOCOL DEVIATION

7. Deviation category:

(Choose primary category. Choose “Other” only if the deviation cannot be classified as any of the given category choices.)

1=Required procedure not performed 2=Required procedure performed outside

of scheduled window 3=Required procedure performed

incorrectly/ not according to protocol 4=Deviation relates to subject eligibility 5=Deviation relates to informed consent process 6=Deviation relates to patient confidentiality or

privacy 7=Deviation relates to general study operations or

procedures 9=Other If other, specify:

8. Reason for deviation: (Choose primary reason. Choose “Other” only if the deviation reason cannot be classified as any of the given choices.)

1=Subject illness 2=Subject unable to comply 3=Subject refusal 4=Study team error 5=Investigator/study decision 6=To eliminate an apparent immediate hazard 9=Other If other, specify:

9. Describe steps taken to resolve or avoid recurrence of the deviation: __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________

Printed name of person completing form: ______________________________________________________ Signature of person completing form: _________________________________________________________ 10.A. Coordinator Code: ___ ___ ___ 10.B. Signature date: ___ ___ / ___ ___ / ___ ___ ___ ___ MM DD YYYY

Additional Comments v1.0 (11.24.14)

CREST-2 Page 1 of 1


FORM 23 ADDITIONAL COMMENTS SHEET

Instructions:

This form is to be used as a continuation of a CRF.

Use one Additional Comments Sheet per CRF item.

NOTE: THIS FORM IS NOT TO BE USED IN LIEU OF REQUIRED CASE REPORT FORMS. NO DIAGNOSIS OR EVENT SHOULD BE REPORTED ON THIS FORM WITHOUT ALSO BEING REPORTED ON THE APPROPRIATE FORM.

1. Date: ___ ___ /___ ___ /___ ___ ___ ___ MM DD YYYY 2. Visit: ______________ This is a continuation sheet for:

3. CRF number: ___ ___

4. CRF page number: ___ ___

5. CRF item number: ___ ___ . ___ . ___ . ___

(NOTE: Complete item number, including periods, must be entered. Enter 99.9.9.9 if no item number.)

6. Comments: __________________________________________________________________________________

________________________________________________________________________________________________

________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________ 7. Coordinator Code: ___ ___ ___

Patient Transfer: Transferring Clinic v1.0 (11.24.14)


FORM 24A

PATIENT TRANSFER: TRANSFERRING CLINIC Instructions: When a patient moves from the original clinic area, the original clinic should notify the SDCC at UAB. The SDCC, the CCC and the original clinic will determine if the patient can be transferred to another CREST-2 site. See the Manual of Procedures for details. All forms from previous visits must be entered and locked before the transfer can occur. Please send a copy of this form with copies of other CREST-2 forms (up to and including last protocol visit) and medical records to the new clinic by overnight courier.

1. Date form completed: __ __ /__ __ /__ __ __ __

MM DD YYYY

2. What was the last visit that your site was responsible for this patient? Visit: ____________

3. Receiving clinic site number: ___ ___ ___

4. Were forms and medical information forwarded to the receiving clinic? 1=Yes 2=No

4.A. If yes, date transferred: __ __ /__ __ /__ __ __ __ MM DD YYYY 4.A.1 Method of transfer: 1=FAX 2=Courier 3=Other Specify: __________________________________________ (Answer Questions 4.A.1.1 and 4.A.1.2 only if method of transfer is ‘Courier’.) 4.A.1.1 Specify courier: 1=FedEx 2=UPS 3=Other Specify: ________________ 4.A.1.2 Tracking number: ______________________________________________________ 4.B. If no, specify reason: _______________________________________________________________


Patient Transfer: Receiving Clinic v1.0 (11.24.14)

CREST-2 Page 1 of 1


FORM 24B

PATIENT TRANSFER: RECEIVING CLINIC

Instructions: Complete this form for each participant transferred to your clinic.

1. Date form completed: __ __ /__ __ /__ __ __ __ MM DD YYYY

2. Were forms and medical information received from the transferring clinic? 1=Yes 2=No 2.A. If yes, date received: __ __ /__ __ /__ __ __ __ MM DD YYYY

2.B. If no, specify reason: _______________________________________________________________

3. Transferring clinic site number: ___ ___ ___

4. Anticipated first protocol visit at your site: _____________


Study Closeout/Termination v1.0 (11.24.14)

TERMINATION REASON CODE

4. Select the reason that best describes why the patient’s participation in the study has been terminated. (Choose only one reason.)

4.A. Completed all study visits =1

4.B. Terminated early due to study closeout

=2

4.C. Terminated early due to death =3

4.D. Terminated early due to lost to follow-up =4

4.E. Terminated early due to refused continued follow up =5

4.E.1. Specify reason (s): __________________________________________________________

4.F. Terminated early due to other reason =6

4.F.1. Specify reason (s): __________________________________________________________

NOTE: IF REASON SELECTED IS 4.D., 4.E., OR 4.F., THIS FORM CANNOT BE LOCKED UNTIL APPROVAL IS PROVIDED BY DR. BROTT. ENTER CODE PROVIDED: ___ ___ ___ ___ Update Medications form (F08), if possible, when patient is terminated from study.



FORM 25 STUDY TERMINATION/ CLOSEOUT

1. Date of patient’s study termination/completion: __ __ /__ __/__ __ __ __

MM DD YYYY 2. Date of last direct communication with patient: __ __ /__ __/__ __ __ __

MM DD YYYY

3. Participant’s last study visit: _____________

Adverse Event/ Serious Adverse Event v1.0 (11.24.14)


FORM 26 ADVERSE EVENT AND OTHER REPORTABLE EVENTS FORM

(includes non-serious Adverse Event [AEs], Serious Adverse Event [SAEs] and other events reportable to the IRB)

Instructions: Complete this form for any new Adverse Event (AE), Serious Adverse Event (SAE) or other events reportable to the IRB. Do not duplicate an ongoing AE, SAE, or other reportable event. Report updates to an ongoing AE, SAE or other reportable event on the initial eCRF on which the event was documented.


ADVERSE AND SERIOUS ADVERSE EVENTS 2. AE/ SAE category: ___ ___ (Select one from the list below.)

SURGICAL WOUND COMPLICATION CARDIAC/VASCULAR01 = Hematoma requiring treatment 10 = Myocardial InfarctionBLEEDING EVENTS 11 = Hypertension02 = Transfusion required 12 = Hypotension03 = Hematoma requiring treatment 13 = Bradycardia-requiring permanent pacemaker04 = Retroperitoneal hemorrhage 14 = Bradycardia-Atropine or no treatment 05 = Bleeding moderate OTHERS 06 = Bleeding minor 15 = Femoral Artery Complications, non-hemorrhagicNEUROLOGICAL 16 = Carotid revascularization07 = Ischemic Stroke 17 = Cranial nerve palsy08 = Hemorrhagic Stroke 18 = Other, specify: 09 = Transient Ischemic Attack

3. AE/ SAE onset date: __ __ /__ __/__ __ __ __ 3.B. Visit:_____________________________________ MM DD YYYY

4. Description of AE/ SAE: _________________________________________________________________

_______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________

5. Severity of AE/ SAE: (Select only one.)

Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Moderate; minimal, local or noninvasive intervention indicated. Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Life-threatening consequences; urgent intervention indicated. Death related to AE/ SAE.

1=Mild 2=Moderate 3=Severe 4=Life-threatening/ Disabling 5=Fatal/ Death




(includes non-serious Adverse Event [AEs], Serious Adverse Event [SAEs] and events reportable to the IRB) 6. Does this event qualify as an unanticipated

event (any risk not mentioned in the protocol or consent form)?

1=Yes 2=No

7. Is this a Serious Adverse Event (SAE) (items

listed in 7.A. determined if the event is a SAE)?

7.A. If yes, specify: (Check all that apply and PI must sign; see Question 19.)

1=Yes 2=No

1 = Death 7.B. Date of death: __ __ /__ __ /__ __ __ __ MM DD YYYY

1 = Life-threatening event 1 = In-patient hospitalization/prolongation of

present hospitalization 1 = Persistent or significant disability/incapacity 1 = Required intervention to prevent

impairment/ damage 1 = Congenital anomaly/birth defect

8. Was further treatment required? (Check all that apply.)

1 = No further treatment required 1 = Medication

Specify: ______________________________ (Update Medications form [F08].)

1 = Surgical Specify: _____________________________

1 = New hospitalization Specify:______________________________

1 = Prolonged hospitalization Specify:_______________________________

1 = Other Specify: ______________________________

9. Is the AE/ SAE related to treatment in the study?

(Select only one.)

9.A. If Possible, Probable, or Definite, specify the related treatments: (Check all that apply.)

1 = Unrelated 2 = Unlikely 3 = Possible (>50% likelihood) 4 = Probable 5 = Definite

1 = Carotid artery stent procedure 1 = Carotid endarterectomy procedure 1 = Device 1 = Blood pressure medication 1 = Statin


CREST-2 Page 3 of 4



(includes non-serious Adverse Event [AEs], Serious Adverse Event [SAEs] and events reportable to the IRB)

10. Is the event considered by the investigator to be

an Unanticipated Adverse Device Effect (UADE) (i.e., outside of the risks listed in the Instructions for use for the device)?

1 = Yes 2 = No

10.A. If yes, specify: _________________________

__________________________________________

__________________________________________

11. Is this an event that may require a change to the

protocol and/or informed consent?

1 = Yes 2 = No

OTHER REPORTABLE EVENTS 12. Are you reporting new information (including

publications or sponsor report) that indicates a change to the risks or potential benefits of the research may be necessary?

1 = Yes 2 = No

13. Are you reporting a breach of confidentiality

(e.g., loss of study data or compromised computer system)?

1 = Yes 2 = No

14. Are you reporting an event that may indicate a

need to change labeling or withdrawal from marketing for safety reasons of a drug or device used in the research protocol?

1 = Yes 2 = No

15. Are you reporting incarceration of a patient?

1 = Yes 2 = No

16. Are you reporting a complaint by a patient that

indicates unexpected risk or cannot be resolved by the research team?

1 = Yes 2 = No

17. Does the site PI feel there is a meaningful change in the risk/benefits for enrolled patients? If the response to Question 16 is ‘Yes’, but Question 17 is answered ‘No’, please explain why changes in research are not needed.

1 = Yes 2 = No

17.A. Specify: ______________________________ ___________________________________________ ___________________________________________


CREST-2 Page 4 of 4



(includes non-serious Adverse Event [AEs], Serious Adverse Event [SAEs] and events reportable to the IRB)

18. Event outcome: (Select only one.)

18.A. If resolved, stop date: __ __ /__ __/__ __ __ __ MM DD YYYY

1 = Resolved 2 = Resolved with sequelae 3 = Ongoing

19. For AEs that are deemed SAEs, review by the Principal Investigator (PI) must be documented with the the PI signature, date of the review and the PI code; please complete below: PI Signature: ___________________________________________________ 19.A. Date of SAE review: __ __ /__ __ /__ __ __ __ MM DD YYYY

19.B. PI Code: ___ ___ ___

20. Provide additional Iinformation about the AE/SAE that the study team would like to bring to our attention: ___________________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________ ____________________________________________________________________________________ ____________________________________________________________________________________

Stroke/ TIA Event v1.0 (11.24.14)

CREST-2 Page 1 of 5


FORM 27 STROKE/ TIA EVENT

Stroke Event Type

1. Date of suspected event: __ __ /__ __ /__ __ __ __ MM DD YYYY

2. Time of suspected event: __ __ : __ __ (24 hr format)

3. Type of neurological event: (Select one response.)

1=Asymptomatic / incidental cerebral infarct noted on imaging only 2=TIA (hemispheric) 3=Cerebral infarct on imaging with symptoms/signs lasting less than 24 hours 4=Cerebral infarction with symptoms/signs lasting longer than 24 hours 5=Monocular blindness 6=Spinal cord infarct 7=Asymptomatic intracranial hemorrhage (details of hemorrhage below) 8=Symptomatic intracranial hemorrhage (details of hemorrhage below)

3.A. Briefly summarize nature of event: __________________________________________________________________________________________

4. Method of diagnosis of neurological event (Check all that apply.)

4.A. 1 = CT scan (Complete Parenchymal Imaging Site [F19] form and send copy of imaging.) 4.A.1. Date of CT: __ __ /__ __ /__ __ __ __ 4.A.2 Time of scan (if available): __ __ : __ __ (24 hr format) MM DD YYYY

4.B. 1 = MRI scan (Complete Parenchymal Imaging Site [F19] form and send copy of imaging.) 4.B.1. Date of MRI: __ __ /__ __ /__ __ __ __ 4.B.2 Time of scan (if available): __ __ : __ __ (24 hr format)

MM DD YYYY

4.C. 1 = Death Certificate (Complete Death form [F32].) 4.C.1. Date of death: __ __ /__ __ /__ __ __ __ MM DD YYYY

4.D. 1=Clinical symptoms (Submit clinical information.)


CREST-2 Page 2 of 5


FORM 27 STROKE/ TIA EVENT

Neurological Event Information 5. Documentation of resolution of

symptoms. 1 =Yes

2 = No

-9 = Unknown

5.A. If yes, date of resolution of symptoms: __ __ /__ __ /__ __ __ __ MM DD YYYY

6. Occurred during catheterization/surgery? 1 =Yes 2 = No

-9 = Unknown

7. Occurred after catheterization/surgery but related to procedure? 1 =Yes 2 = No

-9 = Unknown

8. Related to anticoagulation? 1 =Yes 2 = No

-9 = Unknown

9. Were coagulation tests done after the neurological event?

(If No or Unknown, skip to Q.10.) 1 =Yes 2 = No

-9 = Unknown

If yes, answer each sub-question below, using laboratory data closest to onset of event: 9.A. ACT Test Performed: 1 =Yes

2 = No If yes, value: ___ ___ ___ sec

Date of Test __ __ /__ __ /__ __ __ __ MM DD YYYY

Time of Test __ __ : __ __

(24 hr format)

9.B. PT Test Performed: 1 =Yes 2 = No If yes, value: ___ ___ . ___ sec


Time of Test __ __ : __ __

(24 hr format)

9.C. INR Test Performed: 1 =Yes 2 = No If yes, value: ___ ___ . ___


Time of Test __ __ : __ __

(24 hr format)

9.D. aPTT Test Performed: 1 =Yes 2 = No If yes, value: ___ ___ . ___ sec


Time of Test __ __ : __ __

(24 hr format)

10. Medications at the time of the neurological event: (Please record all anti-thrombotic medications taken within 24 hours of the event.)

10.A. Aspirin 1 =Yes 2 = No -9 = Unknown 10.B. Aggrenox 1 =Yes 2 = No -9 = Unknown 10.C. Clopidogrel 1 =Yes 2 = No -9 = Unknown 10.D. Ticlopidine 1 =Yes 2 = No -9 = Unknown 10.E. Coumadin 1 =Yes 2 = No -9 = Unknown 10.F. Low molecular weight heparin 1 =Yes 2 = No -9 = Unknown 10.G. Unfractionated heparin 1 =Yes 2 = No -9 = Unknown 10.H. Persantine 1 =Yes 2 = No -9 = Unknown 10.I. Dabigatran 1 =Yes 2 = No -9 = Unknown 10.J. Rivaroxaban 1 =Yes 2 = No -9 = Unknown 10.K. Apixaban 1 =Yes 2 = No -9 = Unknown 10.L. Other antithrombotic medication(s) (specify) : _________________________

1 =Yes

2 = No

-9 = Unknown


CREST-2 Page 3 of 5


FORM 27 STROKE/ TIA EVENT FORM

11. Diagnosis: (Answer all questions below.) 11.A. Ischemic Stroke (If No or Unknown, skip to Q. 11.B.)

1 =Yes

2 = No

-9 = Unknown

11.A.1. Symptoms related to ischemic stroke

1 =Yes

2 = No

-9 = Unknown

11.A.2. If 11.A. yes, indicate localization: (Check all that apply.) 1=In the distribution of the target carotid artery territory 1=In the distribution of the non-target carotid artery territory 1=In the vertebrobasilar territory 1=Multiple vascular territories 1=Unknown 11.A.3. If 11.A. yes, indicate pathogenesis: (Select the one most likely pathogenesis.) 1=Large artery atherosclerosis - index ICA (list artery and stenosis) _________________________________________________________________________ 2=Large artery atherosclerosis-not in distribution of index ICA (list artery and stenosis) ________________________________________________________________________ 3=Cardioembolic (list cardiac source) ___________________________________________ 4=Small artery occlusion (lacunar) 5=Other etiology Specify:_____________________________________________________ 6=Related to carotid procedure 7=Other Specify: ____________________________________________________________ -9=Unknown

11.B. TIA (symptoms < 24 hours, does not include monocular symptoms) (If No or Unknown, skip to Q. 11.C.)

1 =Yes, without cerebral infarct on imaging

2 = Yes, with cerebral infarct on imaging

3 = No

-9 = Unknown

11.B.1. If 11.B. yes, indicate localization: (Check all that apply.) 1=In the distribution of the target carotid artery territory 1=In the distribution of the non-target carotid artery territory 1=In the vertebrobasilar territory 1=Multiple vascular territories 1=Unknown

11.C. Monocular blindness (If No or Unknown, skip to Q. 11.D.)

1 =Yes

2 = No

-9 = Unknown

11.C.1. If 11.C. yes, indicate: In the distribution of the target carotid?

1 = Yes

2 = No

-9 = Unknown

11.C.2. If 11.C. yes, did symptoms last longer than 24 hours?

1 =Yes

2 = No

-9 = Unknown


CREST-2 Page 4 of 5



11.D. Spinal cord infarction

1 =Yes

2 = No

-9 = Unknown

11.E. Intracerebral hemorrhage (If No or Unknown, skip to Q. 11.F.)


11.E.1. Symptoms related to intracerebral hemorrhage

1 =Yes

2 = No

-9 = Unknown

11.E.2. If 11.E yes, indicate localization: (Check all that apply.) 1=In the distribution of the target carotid artery territory 1=In the distribution of the non-target carotid artery territory 1=In the vertebrobasilar territory 1=Multiple vascular territories 1=Intraventricular 1=Unknown 11.F. Subarachnoid Hemorrhage (If Q.11.E. and Q.11.F. No or Unknown, skip to Q. 12.)

1 =Yes

2 = No

-9 = Unknown

11.F.1. Symptoms related to subarachnoid hemorrhage

1 =Yes

2 = No

-9 = Unknown

11.F.2. If 11.E. (intracerebral hemorrhage) OR 11.F. (subarachnoid hemorrhage) yes, indicate pathogenesis: (Check all that apply.) 1=Intracranial saccular aneurysm 1=Intracranial vascular malformation 1=Hypertension 1=Intra-operative 1=Anti-coagulant 1=Amyloid angiopathy 1=Other, specify: __________________________ 1=Unknown

12. Subdural hematoma (If No or Unknown, skip to Q. 13.)

1 =Yes

2 = No

-9 = Unknown

12.A.1. Symptoms related to subdural hematoma

1 =Yes

2 = No

-9 = Unknown

13. Epidural hematoma

1 =Yes

2 = No

-9 = Unknown


CREST-2 Page 5 of 5



14. Emergency intervention (If No or Unknown, skip to Q. 15.)

1 =Yes

2 = No

-9 = Unknown

14.A. If Q. 14 yes, indicate type, date, and time of intervention: (Check all that apply.) 1=Carotid Endarterectomy 1=Carotid Artery Stent 1=Intracranial endovascular recanalization procedure 1=Intravenous Thrombolytics 1=Heparin 1=GP IIb/IIIa agent 1=Other, specify: ______________________________________ 14.B. Date of intervention: __ __ /__ __ /__ __ __ __

MM DD YYYY

14.C. Time of intervention: __ __ : __ __ (24 hr format)

Please enter Additional Comments Form (F23) with additional information, if necessary

(including summary of relevant vascular imaging). Please submit all related (deidentified) source documents to the

Events and Adjudication Committee. Please see MOP for submission details.

____________________________________________________ Signature of Principal Investigator

15. Date: __ __ /__ __ /__ __ __ __ MM DD YYYY

16. Code: ___ ___ ___

Cranial Nerve Palsy Event v1.0 (11.24.14)


FORM 28 CRANIAL NERVE PALSY (CNP) EVENT

Instructions:

Complete this form only if patient has CNP event following initial procedure. Per protocol, cranial nerve injury must be re-assessed at 1 and 4 month visits. If CNP has not resolved by 4 month visit, it must be re-checked at 1 year. Complete an Adverse Event form (F26) if one has not been completed for this event.


2. Visit interval:

1=Post-procedure (Complete Questions 3-5.) 2=1 month (Skip to Question 6.) 3=4 month (Skip to Question 6.) 4=12 month (Only required if symptoms have not resolved by 4 month visit. Skip to Q.6.


4. Date CNP symptom(s) began: __ __ /__ __ /__ __ __ __ MM DD YYYY

5. Cranial nerve(s) affected:

5.A. VII (Facial) 1 =Yes 2 = No -9 = Unknown

5.A.1. Side affected 1 =Right 2 = Left 3 = Both

5.A.2. If yes, what symptoms: (Check all that apply.)

1 = Mild weakness

1 = Severe weakness (difficulty in controlling saliva and closing eye)

5.B. IX (Glossopharyngeal) 1 =Yes 2 = No -9 = Unknown

5.B.1. Side affected 1=Right 2 = Left 3 = Both

5.B.2. If yes, what symptoms: (Check all that apply; 3 oz swallow test strongly recommended to test severity)

1 = Mild dysphagia (swallow test passed)

1 = Severe dysphagia (swallow test failed)

1 = Hypogeusia (loss of taste in the posterior third of the tongue)

5.B.3. In the investigator’s opinion is the dysphagia related to the index procedure?




FORM 28

CRANIAL NERVE PALSY (CNP) EVENT

5.C. X (Vagus) 1 =Yes 2 = No -9 = Unknown

5.C.1. Side affected 1=Right 2 = Left 3 = Both

5.C.2. If yes, what symptoms: (Check all that apply.)

1 = Hoarse or nasal voice

1 = Vocal cord paralysis

1 = Dysphagia

1 = Nasal reflux

5.D. XII (Hypoglossal) 1 =Yes 2 = No -9 = Unknown

5.D.1. Side affected 1=Right 2 = Left 3 = Both

5.D.2. If yes, what symptoms: (Check all that apply.)

1 = Dysphagia, clumsiness with mastication

1 = Dysphagia (mild)

1 = Tongue deviated to side of palsy when protruded

5.E. Cervical (Cutaneous) 1 =Yes 2 = No -9 = Unknown

5.E.1. Side affected 1=Right 2 = Left 3 = Both

5.E.2. If yes, what symptoms: (Check all that apply.)

1 = Numbness over ear and angle of jaw

1 = Paresthesia over the relevant dermatome

5.F. Horner Syndrome 1 =Yes 2 = No -9 = Unknown

5.F.1. Side affected 1=Right 2 = Left 3 = Both

5.F.2. If yes, check what symptoms: (Check all that apply.)

1 = Ptosis

1 = Pupil asymmetry (miosis)


CREST-2 Page 3 of 3


FORM 28

CRANIAL NERVE PALSY (CNP) EVENT

NOTE: Skip Question 6 if visit interval is post-procedure.

6. Have all symptoms resolved? 1 =Yes 2 = No -9 = Unknown

NOTE: Once the symptoms have resolved, this form does not need to be completed at future visits. 6.A. If no, indicate current symptoms: _________________________________________

_________________________________________________________________________

_________________________________________________________________________

Please enter Additional Comments form (F23) with additional information, if necessary.

Please submit all related (deidentified) source documents to the Events and Adjudication Committee.

Please see MOP for submission details.

__________________________________________________ Signature of Principal Investigator

7. Date signed: __ __ /__ __ /__ __ __ __ MM DD YYYY

8. Code: ___ ___ ___

Embolic Device/Stent Failure Form v1.0 (11.24.14)

CREST-2 Page 1 of 2

PID1: __ __ __ - __ __ __ __ PID2: __ __ __ - __ __ __ __ __

SITE ID SITE ID

FORM 29 EMBOLIC PROTECTION DEVICE AND STENT TREATMENT FAILURE

Instructions: Please complete one form for each date and event (or events) that occurred.

1. Date form completion: __ __ /__ __ /__ __ __ __ MM DD YYYY

2. Was there failure to deliver or recover the embolic protection device?

1=Yes 2=No 3=NA If yes, answer each item:

2.A. Never able to cross lesion with guidewire 1=Yes 2=No 2.B. Never able to cross lesion with device 1=Yes 2=No 2.C. Unable to reach lesion 1=Yes 2=No 2.D. Unable to access common carotid 1=Yes 2=No 2.E. Adverse event during pre-treatment 1=Yes 2=No 2.F. Unable to recover the embolic protection system 1=Yes 2=No 2.G. Deterioration in patient’s clinical status 1=Yes 2=No If any response to 2.A. through 2.G. is “Yes”, please complete appropriate Adverse Event forms.

2.H. Other Specify: _________________________ 1=Yes 2=No

3. Was there failure to deliver stent? 1=Yes 2=No

If yes, answer each item:

3.A. Never able to cross lesion with guidewire 1=Yes 2=No 3.B. Never able to cross lesion with device 1=Yes 2=No 3.C. Unable to reach lesion 1=Yes 2=No 3.D. Unable to access common carotid 1=Yes 2=No 3.E. Adverse event during pre-treatment 1=Yes 2=No 3.F. Deterioration in patient’s clinical status 1=Yes 2=No

If any response to 3.A. through 3.F. is “Yes”, please complete appropriate Adverse Event forms.

3.G. Other Specify: _________________________ 1=Yes 2=No

Embolic Device/Stent Failure Form v1.0 (11.24.14)

CREST-2 Page 2 of 2


FORM 29 EMBOLIC PROTECTION DEVICE AND STENT TREATMENT FAILURE

4. Was further percutaneous or surgical revascularization attempted at this site?

1=Yes 2=No If yes, complete a separate Adverse Event form (F26) and Carotid Revascularization form (F31) for EACH revascularization.

Please enter Additional Comments Form (F23) explaining failure.

Please submit all related (deidentified) source documents to the Events and Adjudication Committee. Please see MOP for submission details.

Name of person completing form:_________________________________________



Bleeding/Vascular Complication Form v1.0 (11.24.14)


FORM 30 BLEEDING/ VASCULAR COMPLICATION

Instructions: Please complete one form for each date and event (or events) that occurred.


2. Did the patient experience a complication at a catheterization site? 1=Yes 2=No

If no, skip to Question 3.

If yes,

2.A. Did the patient have a hematoma that required treatment? 1=Yes 2=No

If no, skip to Question 2.B. If yes, answer Questions 2.A.1 – 2.A.4.

2.A.1 Date event diagnosed: __ __ /__ __ /__ __ __ __ MM DD YYYY

2.A.2 Ultrasound compression: 1=Yes 2=No

2.A.3 Surgical repair: 1=Yes 2=No

2.A.4 Transfusion: 1=Yes 2=No

2.B. Did the patient have a false aneurysm? 1=Yes 2=No

If no, skip to Question 2.C. If yes, answer Questions 2.B.1 – 2.B.4.

2.B.1 Date event diagnosed: __ __ /__ __ /__ __ __ __ MM DD YYYY

2.B.2 Ultrasound compression: 1=Yes 2=No

2.B.3 Surgical repair: 1=Yes 2=No

2.B.4 Transfusion: 1=Yes 2=No

2.C. Did the patient have an AV fistula? 1=Yes 2=No

If no, skip to Question 2.D. If yes, answer Questions 2.C.1 – 2.C.4.

2.C.1 Date event diagnosed: __ __ /__ __ /__ __ __ __ MM DD YYYY

2.C.2 Ultrasound compression: 1=Yes 2=No

2.C.3 Surgical repair: 1=Yes 2=No

2.C.4 Transfusion: 1=Yes 2=No




2.D. Did the patient have a retroperitoneal bleed? 1=Yes 2=No

If no, skip to Question 2.E. If yes, answer Questions 2.D.1 – 2.B.4.

2.D.1 Date event diagnosed: __ __ /__ __ /__ __ __ __ MM DD YYYY

2.D.2 Ultrasound compression: 1=Yes 2=No

2.D.3 Surgical repair: 1=Yes 2=No

2.D.4 Transfusion: 1=Yes 2=No

2.E. Did the patient experience a peripheral limb ischemia/nerve injury? 1=Yes 2=No

If no, skip to Question 3. If yes, answer Questions 2.E.1 – 2.E.4.

2.E.1 Date event diagnosed: __ __ /__ __ /__ __ __ __ MM DD YYYY

2.E.2 Surgical repair: 1=Yes 2=No

3. Did the patient experience a complication at the surgical incision? 1=Yes 2=No

If no, skip to Question 4. If yes, provide information below and complete an Additional Comments form (F23).

3.A. Date event occurred: __ __ /__ __ /__ __ __ __

MM DD YYYY

3.B. Required further treatment: 1=Yes 2=No

4. Did the patient require a transfusion for any reason? 1=Yes 2=No

If no, skip to Question 5. If yes, answer Questions 4.A. - 4.C. 4.A. Date/time of first transfusion: __ __ /__ __ /__ __ __ __ ___ ___ : ___ ___ MM DD YYYY 24 Hour

4.A.1 Transfusion related to catheterization complications? 1=Yes 2=No 4.B. Excessive bleeding at catheterization site requiring transfusion? 1=Yes 2=No 4.B.1 Total number of units of blood transfused? ___ ___ 4.B.2 Total number of units of platelets transfused? ___ ___ 4.C. Adverse event related to transfusion? 1=Yes 2=No

Please complete an Adverse Event (F26) and Additional Comments (F 23) forms if transfusion occurred within 30 days of procedure (or within 30 days of randomization if patient did not receive assigned treatment) or if the transfusion was potentially study-related.


CREST-2 Page 3 of 3

PID1: __ __ __ - __ __ __ __ PID2: __ __ __ - __ __ __ __ __

SITE ID SITE ID


5. Did the patient experience a vessel complication? 1=Yes 2=No

If no, skip to Question 6. If yes, answer Question 5.A.

5.A. Vessel perforation? 1=Yes 2=No If no, skip to Question 6. If yes, answer Question 5.A.1 – 5.A.3.

5.A.1 Date/time of complication: __ __ /__ __ /__ __ __ __ ___ ___ : ___ ___ MM DD YYYY 24 Hour

5.A.2 Required emergency surgery? 1=Yes 2=No 5.A.3 Carotid artery dissection? 1=Yes 2=No If no, skip to Question 6. If yes, answer Questions 5.A.3.A – 5.A.3.C and complete an Additional Comments form (F23). 5.A.3.A. Date event diagnosed: __ __ /__ __ /__ __ __ __

MM DD YYYY

5.A.3.B. Surgical repair? 1=Yes 2=No 5.A.3.C. Endovascular repair? 1=Yes 2=No

Please enter Additional Comments Form (F23) explaining revascularization. Please submit all related (deidentified) source documents to the Events and Adjudication Committee.

Please see MOP for submission details.

__________________________________________________ Signature of Principal Investigator


7. PI Code: ___ ___ ___

Repeat Carotid Revascularization v1.0 (11.24.14)

CREST-2 Page 1 of 2


FORM 31 CAROTID REVASCULARIZATION

Instructions:

Complete this form for each revascularization procedure after the index procedure or any revascularization procedure other than the procedure to which patient was randomized.


2. Lesion site revascularized: 1=Right 2=Left


4. Revascularization anatomy: (Answer both below.)

4.A. Involves target artery 1=Yes 2=No

4.B. Involves non-target artery 1=Yes 2=No

5. Type of revascularization: 1=Percutaneous 2=Surgical

If percutaneous, complete Questions 5.A. – 5.E. If surgical, skip to Question 5.F.

5.A. Time procedure began (arterial puncture): ___ ___: ___ ___ (24 hr format) 5.B. Time procedure ended (last cath removed): ___ ___ : ___ ___ (24 hr format) If time procedure began or ended is unknown, enter 99:99. 5.C. Indicate device(s) used:

5.C.1 Balloon 1=Yes 2=No

5.C.2 Stent 1=Yes 2=No

5.C.3 Other 1=Yes 2=No

If other, specify: __________________________ 5.D. Indicate urgency of procedure: 1=Elective 2=Urgent 5.E. Was revascularization successful? 1=Yes 2=No

If yes, skip to end of form for signature, date, and date code. If no, please complete Additional Comments form (F23), explaining why revascularization was not successful.

Repeat Carotid Revascularization v1.0 (11.24.14)

CREST-2 Page 2 of 2


FORM 31 CAROTID REVASCULARIZATION

If surgical, complete Questions 5.F. – 5.J.:

5.F. Operating room procedure duration (defined as anesthesia start time to anesthesia end time):

___ ___ : ___ ___ (hr:min)

5.G. Indicate urgency of surgery: 1=Elective 2=Urgent

5.H. Was CEA successful? 1=Yes 2=No

5.I. Was a patch used? 1=Yes 2=No

If yes, specify:

5.I.1. Prosthetic 1=Yes 2=No

5.I.2. Saphenous Vein Graft 1=Yes 2=No

5.I.3. Neck Vein Graft 1=Yes 2=No

5.I.4. Other 1=Yes 2=No

If other, specify:

5.J. Shunts: 1=Yes 2=No

If yes,

5.J.1. Total occlusion time: ___ ___ : ___ ___ (hr:min)

If CEA was successful, continue to end of form for signature, date and code. If CEA was not successful, please complete Additional Comments form (F23), explaining why revascularization was not successful. Signature of Operator or Surgeon: __________________________________________

6. Date reviewed: __ __ /__ __ /__ __ __ __ MM DD YYYY

7. Operator or Surgeon Code: ___ ___ ___

Death v1.0 (11.24.14)


FORM 32 DEATH

1. Date of death: __ __ /__ __ /__ __ __ __ 1.A.Time of death: __ __ : __ __ (24 hr format)

MM DD YYYY Instructions: This form does not take the place of the appropriate event form or Study Termination/Closeout form (F25). Please submit all source documents to Events and Adjudication Committee as soon as data are obtained. See MOP for details.

2. Primary cause of death as judged by the site PI: (Select one answer.)

1=Ischemic stroke (Please complete Stroke/TIA Event form.) 2=Intracerebral hemorrhage (Please complete Stroke/TIA Event form.) 3=Subarachnoid hemorrhage (Please complete Stroke/TIA Event form.) 4=Coronary disease/Myocardial infarction 5=Congestive heart failure 6=Pulmonary embolism 7=Respiratory disease (not pulmonary embolism) 8=Cancer 9=Sudden death of uncertain cause 10=Other Specify: ____________________________________________________________

3. Contributing cause(s) of death as judged by the site PI: (Check all that apply.)

1=Ischemic stroke (Please complete Stroke/TIA Event form.) 1=Intracerebral hemorrhage (Please complete Stroke/TIA Event form.) 1=Subarachnoid hemorrhage (Please complete Stroke/TIA Event Form.) 1=Coronary disease/Myocardial infarction 1=Congestive heart failure 1=Pulmonary embolism 1=Respiratory disease (not pulmonary embolism) 1=Cancer 1=Sudden death of uncertain cause 1=Other Specify: _____________________________________________________________

4. Data used to document cause of death: (Check all that apply and submit documentation per MOP.)

1=Medical record 1=Physician letter 1=Death certificate 1=Autopsy 1=Other Specify: ____________________________________________________________

Death v1.0 (11.24.14)


FORM 32 DEATH

5. Was the death related to the index procedure? 1=Yes 2=No 3=N/A -9=Unknown

6. Was the death related to the study device? 1=Yes 2=No 3=N/A -9=Unknown

6.A. If yes, indicate which device(s): 1=Stent 2=Embolic Protection Device 3=Both -9=Unknown

7. Was an autopsy performed? (If yes, please submit copy of autopsy report to Events and Adjudication Committee.)

1=Yes, available 2=Yes, not available at this time 3=No -9=Unknown

8. Please give a brief narrative of circumstances surrounding death and attach the appropriate

documentation (e.g., MD’s note at death, resuscitation record, discharge summary):

________________________________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

___________________________________________ Principal Investigator Signature

9. Date: __ __ /__ __ /__ __ __ __

MM DD YYYY

10. Principal Investigator Code: ___ ___ ___

CREST-2 Page 1 of 2


FORM 34 PATIENT CONTACT INFORMATION

1. Study visit: ____ 2. Call ID: ____


4. Will clinic call SRU for Cognitive Assessment to be conducted? 1=Yes 2=No

4.A. If no, enter date assessment to be completed: __ __ /__ __ /__ __ __ __ MM DD YYYY 4.B. If no, time: __ __ :__ __ (24 hr format)

1=Newfoundland 2=Atlantic 3=Eastern 4=Central 5=Mountain 6=Pacific

5. Has any of the contact information changed since the last visit? 1=Yes 2=No 6. Patient Name

___________________ ____ ______________________ First M.I. Last

7. Address _________________________________________________________

Street

_________________________________________________________ City

Country: 1=United States 2=Canada

____________________________ ___________________ State/Province Postal/Zip Code

8. Phone (Enter with hyphens and no spaces. Enter 999-999-9999 if a number is not available.)

9. Best Time to Call

__ __ __ - __ __ __ - __ __ __ __ 1=Home 2=Mobile 3=Work

__ __ __ - __ __ __ - __ __ __ __ 1=Home 2=Mobile 3=Work

1=Morning 2=Afternoon 3=Evening

10. Social Security/ Insurance Number

__ __ __ __ __ __ __ __ __ (Enter without hyphens or spaces. (If patient refuses, enter 999999999.)

11. Date of Birth

__ __ /__ __ /__ __ __ __ MM DD YYYY

12. Email Address

__________________________________

Patient Contact Information v2.0 (01.27.15)

CREST-2 Page 2 of 2


13. Does the patient have an Alternate Contact? 1=Yes 2=No

14. Name

___________________ ____ ______________________ First M.I. Last

15. Relationship to Patient 1=Spouse 2=Child 3=Parent 4=Other, specify _________


__ __ __ - __ __ __ - __ __ __ __ 1=Home 2=Mobile 3=Work

__ __ __ - __ __ __ - __ __ __ __ 1=Home 2=Mobile 3=Work

17. Does the patient have a Second Alternate Contact? 1=Yes 2=No

18. Name

___________________ ____ ______________________ First M.I. Last

19. Relationship to Patient 1=Spouse 2=Child 3=Parent 4=Other, specify _________


__ __ __ - __ __ __ - __ __ __ __ 1=Home 2=Mobile 3=Work

__ __ __ - __ __ __ - __ __ __ __ 1=Home 2=Mobile 3=Work

Primary Care Physician Contact Information

21. Name ________________ _____________________ First Last


__ __ __ - __ __ __ - __ __ __ __

23. Address _________________________________________________________

Street

_________________________________________________________ City

Country: 1=United States 2=Canada

____________________________ ___________________ State/Province Postal/Zip Code

24. Does the patient have medication insurance? 1=Yes 2=No


Patient Contact Information v2.0 (01.27.15)

FORM 00 STUDY VISIT STATUS · INR > 1.5, or history of heparin-induced thrombocytopenia? 1=Yes 2=No...

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Transcript of FORM 00 STUDY VISIT STATUS · INR > 1.5, or history of heparin-induced thrombocytopenia? 1=Yes 2=No...