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![Page 1: Pre-stent plaque modification in complex, calcified coronary artery lesions AngioSculpt® A New Scoring Balloon Ehud Grenadier M.D Cardiac catheterization.](https://reader033.fdocuments.net/reader033/viewer/2022051216/5697bfad1a28abf838c9c3c8/html5/thumbnails/1.jpg)
Pre-stent plaque modification in complex, calcified coronary
artery lesions
Pre-stent plaque modification in complex, calcified coronary
artery lesions
AngioSculpt®A New Scoring Balloon
Ehud Grenadier M.DEhud Grenadier M.D
Cardiac catheterization LabsCardiac catheterization LabsHaifa;Herzlia Haifa;Herzlia
ISRAEL ISRAEL
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Why is Lesion Why is Lesion
Preparation Preparation
EssentialEssential??
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MSD as percent of RLD
MSD as a percentage of RLD following stent deployment. Optimum stent deployment : (MSD 90% RLD).
Patients not achieving criteria with the stent delivery system (71%)
Brodie B. et al POSTIT Trial, Cath. Card. Int. 2003: 59,184-192.
Per
cen
t o
f P
op
ula
tio
n
40 50 60 70 80 90 100 120 130
Patients who did not achieve optimal stent deployment with SDS
POSTIT TrialPOSTIT Trial : when using only the stent delivery balloon : when using only the stent delivery balloon over 70% of the pts. did not achieve optimal stent deploymentover 70% of the pts. did not achieve optimal stent deployment..
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++++++
++ ++++
++++
++++
+
++++ ++++ +
++xx x
xxxxxxxx
xxx
x xx
xxx
xxx
xxxx x
x
++
xxxx
2.5 3.0 3.5 4.0 4.5
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Manufacturer’s Predicted MSD (mm)
IVU
S M
eas
ure
d M
SD
(m
m) Nominal S
tent Size
Manufacturer AManufacturer BManufacturer CManufacturer Dx
+
Costa et al, Am J Cardiol 2005:96,74-78
Manufacturer’s Predicted Minimal Stent Diameter Manufacturer’s Predicted Minimal Stent Diameter (MSD) is Usually Not Achieved With the Original (MSD) is Usually Not Achieved With the Original
Stent BalloonStent Balloon
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IVUS guidance may result in more effective
stent expansion and results in 44% reduction
in TVR
Only 22% of patients that experience SAT have an optimum PCI result as assessed by
IVUS
CRUISE study: Peter J. Fitzgerald et.al. “Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study”
Circulation 2000 102:523-530
.Cheneau Study: Edouard Cheneau,et al. “Predictors of Subacute Thrombosis. Results
of a Systematic Intravascular Ultrasound Study.” Circulation 2003; 108:43-47
T
V
R
S
A
T
Non-uniform stent strut distribution and
malapposition may result in more intimal
hyperplasia after stenting
MSA and stent under expansion
are major predictors of
stent thrombosis
RESTENOSIS
Takebayastri Study: Hideo Takebayastri et al. “Non-uniform Strent Strut Distribution
Correlates with More Neointimal Hyperplasia after Sirolimus-Elluting Stent Implantation”
Circulation 2004;110:3430-3434
B.Brodie. Adjunctive balloon post dilatation after stent deployment. J Interven Cardiol
2006;19:43-50
THROBOSIS
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Benefit of the AngioSculpt Benefit of the AngioSculpt for Pre-dilatation of DESfor Pre-dilatation of DES
Benefit of the AngioSculpt Benefit of the AngioSculpt for Pre-dilatation of DESfor Pre-dilatation of DES
Group I (n=145)Group II (n=117)
Group III (n=37)
p value
MSD/PSD76% ± 10%76% ± 13%88% ± 18%<0.001
MSA/PSA67% ± 16%70% ± 23%88% ± 22%<0.001
Final stent CSA < 5.0mm226.2%25.6%10.8%0.03
Costa et al, AHA 2006
Group I = direct stenting
Group II = pre-dilatation with POBA
Group III = pre-dilatation with AngioSculpt
CSA = cross sectional area, MSA = minimum stent area, MSD = minimum stent diameter,
PSA = predicted stent area, PSD = predicted stent diameter
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AngioSculpt Scoring Balloon AngioSculpt Scoring Balloon CatheterCatheter
Semi-compliant balloon with an Semi-compliant balloon with an external external
nitinol shape memory helical scoring nitinol shape memory helical scoring edgeedge
Semi-compliant balloon with an Semi-compliant balloon with an external external
nitinol shape memory helical scoring nitinol shape memory helical scoring edgeedge
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Centrally Located Within the Arterial Lumen
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The AngioSculpt is The AngioSculpt is Comprised ofComprised of : :
A - Rapid exchange or OTW semi-compliant A - Rapid exchange or OTW semi-compliant balloonballoon
B - Laser cut nitinol scoring elementB - Laser cut nitinol scoring element
A B
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Acute histopathology specimen of a patient post conventional
balloon angioplasty demonstrating extensive dissection and laceration
(yellow arrows)
Post-AngioSculpt scoring of porcine ISR (yellow arrows)
Histopathology of the AngioSculpt vs. Histopathology of the AngioSculpt vs. POBAPOBA
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Use of the Angiosculpt for Pre-dilation of Use of the Angiosculpt for Pre-dilation of Challenging Coronary Lesions Prior to Challenging Coronary Lesions Prior to
Stenting Stenting
Personal ExperiencePersonal Experience
Use of the Angiosculpt for Pre-dilation of Use of the Angiosculpt for Pre-dilation of Challenging Coronary Lesions Prior to Challenging Coronary Lesions Prior to
Stenting Stenting
Personal ExperiencePersonal Experience Ehud Grenadier, Arthur Kerner, Nabeel
Makhoul, Luis Gruberg, Ariel Roguin
Herzliya & Rambam Med. Ctrs. Herzliya & Haifa, ISRAEL
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Aims of the StudyAims of the Study
To evaluate the Deliverability, Efficacy, and Safety of the
AngioSculpt Scoring Balloon Catheter
in patients with challenging and calcific CAD
To evaluate the Deliverability, Efficacy, and Safety of the
AngioSculpt Scoring Balloon Catheter
in patients with challenging and calcific CAD
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Study Design
Two-center, prospective, consecutive, non-randomized single operator registry
Inclusion criteria: pts with single or multi-vessel coronary artery disease scheduled to undergo PCI
Population: 221 consecutive pts enrolled at 2 sites
Follow-up: outpatient visits, telephone interviews and re-catheterization if clinically indicated
Two-center, prospective, consecutive, non-randomized single operator registry
Inclusion criteria: pts with single or multi-vessel coronary artery disease scheduled to undergo PCI
Population: 221 consecutive pts enrolled at 2 sites
Follow-up: outpatient visits, telephone interviews and re-catheterization if clinically indicated
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I.V.U.S - VirtualI.V.U.S - Virtual HistologyHistology
Evaluated in 60/221 [ 27.1 %] pts. 76/279 [ 27.2 %] lesions
“Volcano Therapeutics” IVG - 3 / S-5
Eagle Eye Gold IVUS catheter
Evaluated in 60/221 [ 27.1 %] pts. 76/279 [ 27.2 %] lesions
“Volcano Therapeutics” IVG - 3 / S-5
Eagle Eye Gold IVUS catheter
Performed in 111/221 [ 49.7 % ] pts. 154/279 [ 55.2 % ] lesionsPerformed in 111/221 [ 49.7 % ] pts. 154/279 [ 55.2 % ] lesions
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AngioSculpt AngioSculpt Relative ContraindicationsRelative Contraindications
Unprotected left main diseaseUnprotected left main disease
Non-calcified SVG lesionNon-calcified SVG lesion
Thrombotic lesionThrombotic lesion
Unprotected left main diseaseUnprotected left main disease
Non-calcified SVG lesionNon-calcified SVG lesion
Thrombotic lesionThrombotic lesion
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Primary Performance Primary Performance EndpointEndpoint
Procedural Success
Final diameter stenosis ≤10% in all AngioSculpt treated lesions following completion of the interventional procedure (including adjunctive stenting when used) without in-hospital major adverse cardiac events (MACE)
Procedural Success
Final diameter stenosis ≤10% in all AngioSculpt treated lesions following completion of the interventional procedure (including adjunctive stenting when used) without in-hospital major adverse cardiac events (MACE)
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Primary Safety Primary Safety EndpointEndpoint
Clinical Success
Successful PCI and freedom from MACE at 30 day follow-up
MACE is defined as death, Q wave or non-Q wave MI, CABG or TLR of the index lesion
Clinical Success
Successful PCI and freedom from MACE at 30 day follow-up
MACE is defined as death, Q wave or non-Q wave MI, CABG or TLR of the index lesion
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Secondary Secondary EndpointsEndpoints
Flow limiting dissectionFlow limiting dissection
Vessel perforationVessel perforation
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Patient Patient DemographicsDemographics
221 pts, 279 lesions221 pts, 279 lesions Age: 63.8±19.4 yrs (range 34 – 88)Age: 63.8±19.4 yrs (range 34 – 88) Males: 72%Males: 72% Severe Angina (CCS class 3-4): 56%Severe Angina (CCS class 3-4): 56% Prior PCI: 43%Prior PCI: 43% Prior MI: 34%Prior MI: 34% Prior CABG: 6%Prior CABG: 6%
Age: 63.8±19.4 yrs (range 34 – 88)Age: 63.8±19.4 yrs (range 34 – 88) Males: 72%Males: 72% Severe Angina (CCS class 3-4): 56%Severe Angina (CCS class 3-4): 56% Prior PCI: 43%Prior PCI: 43% Prior MI: 34%Prior MI: 34% Prior CABG: 6%Prior CABG: 6%
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Risk Factors
0
10
20
30
40
50
60
70
Hypercholesterolemia Diabetes Family history of CAD
5.7%5.7%
NIDDMNIDDM
58.7%58.7%
35.8%35.8%
41.2%41.2%%%
IDDMIDDM
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Vessel DistributionVessel Distribution
2
36
4
1715
30
0
5
10
15
20
25
30
35
40
LM protected LAD Diagonal LCx LCxM RCA
%
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Lesion CharacteristicsLesion Characteristics
ISR: 51/279 [18%], De-Novo: 228/279 [82%] Bifurcation: 69/279 [25%] Eccentric: 117/279 [42%] Ulcerated: 31/279 [11%] >30° angulation: 154/279[55%]
Mean lesion angulation: 34.3±17˚
ISR: 51/279 [18%], De-Novo: 228/279 [82%] Bifurcation: 69/279 [25%] Eccentric: 117/279 [42%] Ulcerated: 31/279 [11%] >30° angulation: 154/279[55%]
Mean lesion angulation: 34.3±17˚
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Lesions Classification (AHA/ACC)
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Calcification Severity Calcification Severity
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Pre-Procedure QCAPre-Procedure QCA
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Pre-Procedure Lesion Pre-Procedure Lesion Measurements (QCA)Measurements (QCA)
Length(mm)
MLD(mm)
RVD [d](mm)
17.1+11.40.26±0.292.69±0.35
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Primary Endpoint Primary Endpoint ResultsResults
Procedural Success: 96.0% [268/279]
Clinical Success: 94.6% [209/221]
Procedural Success: 96.0% [268/279]
Clinical Success: 94.6% [209/221]
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AngioSculpt “Only” Procedural Success
Diameter stenosis <50%: 224/279 [80%]
Diameter stenosis ≤20%: 158/279 [57%]
Final failure to cross with the AngioSculpt occurred in 8/279 lesions [2 .9%], all occurred in severe, calcified
lesions with pronounced vessel/lesion angulation
Diameter stenosis <50%: 224/279 [80%]
Diameter stenosis ≤20%: 158/279 [57%]
Final failure to cross with the AngioSculpt occurred in 8/279 lesions [2 .9%], all occurred in severe, calcified
lesions with pronounced vessel/lesion angulation
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QCA ResultsQCA ResultsDiameter StenosisDiameter Stenosis)%( )%(
Pre-ASCPre-ASCPost-ASCPost-ASCPost-StentPost-Stent
82.982.9++11.11.2 2 23.523.5++13.613.65.95.9++4.4 4.4
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QCA Results (cont’d)QCA Results (cont’d)Minimum Luminal Diameter Minimum Luminal Diameter
(mm)(mm)
Pre-ASCPre-ASCPost-ASCPost-ASCPost-Post-StentStent
0.260.26++0.20.299
2.072.07++0.680.682.432.43++0.70.722
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IVUS Results IVUS Results MLD (mm) and MLD (mm) and CSA (mmCSA (mm22))
MLD, CSA Ref. Vessel
(d)
MLD, CSA Pre-
dilatation
MLD, CSAPost-ASC
P-Value*MLD, CSAPost-stent
P-Value*
2.99±0.587.1±2.9
1.7±0.142.57±0.45
2.1±0.353.86±1.0
8
p<0.0001
p<0.0001
2.82±1.15.5±2.03
p<0.002p<0.000
1
*Paired t-Test
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IVUS ResultsIVUS ResultsLesion CharacteristicsLesion Characteristics
Mod-Severe Ca++Eccentric
Post-ASC “Controlled” Dissections
72.4 %39.1%82.7 %
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AngioSculpt Dimensions & AngioSculpt Dimensions & Inflation PressuresInflation Pressures
ASC Diameter(mm)
ASC Length(mm)
Inflation Pressure(atm)
2.51+0.3416.4+3.315.1+2.4
range: 10-18
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Reduction in Usage Reduction in Usage of NC Balloonsof NC Balloons
Usage of NC Balloons Pre-ASC
Usage of NC Balloons in ASC
Study
Reduction in Usage of NC
Balloons
89% 43% 46%
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AngioSculpt CrossabilityAngioSculpt Crossability
Planned POBA Pre-
ASC
Successful Primary
ASC
POBA Pre-dilatation
After Primary ASC Failure to
Cross
Failure to Cross with ASC
After POBA Pre-dilatation
Predicted Failure to
Cross (ASC not
attempted)
113/279[40.5%]
104/279[37.3%]
31/279[11.1%]
8/279[2.9%]
1/279 [0.4%]
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Device SlippageDevice Slippage
Device slippage was observed in 4/271 [1.5 %] of ASC treated lesions
Device slippage was observed in 4/271 [1.5 %] of ASC treated lesions
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Double Wire TechniquesDouble Wire Techniques
In 11/279 [3.9 %] lesions the additional use of a buddy wire resulted in successful crossing of 6/11 lesions
The anchor wire [LCA] was used in 5/279 [1.8%] lesions resulting in successful crossing in 3/5 lesions
In 11/279 [3.9 %] lesions the additional use of a buddy wire resulted in successful crossing of 6/11 lesions
The anchor wire [LCA] was used in 5/279 [1.8%] lesions resulting in successful crossing in 3/5 lesions
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Stent Types Used in the StudyStent Types Used in the Study
21%
33%17%
15%14%
Cypher Taxus Endeavor Titan Other stents
Stents were implanted in 264/279 [94.6%] lesions Stents were implanted in 264/279 [94.6%] lesions
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Distal Left Main and Proximal LCx Lesions
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ANGIOSCULPT 2.0 x 15 mm
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POST-DES INSERTION
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IVUS Demonstrates Optimal Stent Apposition
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Angiogram and IVUS Pre-Intervention
MLD = 1.2mmMLA = 1.5mm²
Plaque area = 5.72mm²Plaque burden = 83%
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Angiogram and IVUS Post-AngioSculpt
MLD = 1.4 mm
MLA = 3.1 mm²
Plaque area = 4.8 mm²
Plaque burden = 63%
Yellow arrows indicate “scoring marks”
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Angiogram and IVUS Post-Stent
MLD = 2.6 mm
MSA = 5.2 mm²
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Severe calcified Lcx LesionSevere calcified Lcx Lesion
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Angiosculpt DilationAngiosculpt Dilation
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Final Angiographic ResultFinal Angiographic Result [ Post Taxus Stent Insertion ] [ Post Taxus Stent Insertion ]
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Distal long RCA lesion
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Pre dilated RCA lesion - Q.C.A Analysis
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3.0/20 mm and 3.5/15 3.0/20 mm and 3.5/15 mm Angiosculpt mm Angiosculpt
PredilationPredilation
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3.53.5 mm Endeavor Stent Insertionmm Endeavor Stent Insertion
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FINAL Angiographic RESULTFINAL Angiographic RESULT
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Cumulative MACE @ 30 day F/U Cumulative MACE @ 30 day F/U 215/221 [97.2%] pts215/221 [97.2%] pts
ComplicationRateTotal MACE6/221 [2.7 %]
Death at day 10 [ non cardiac ] Sepsis ? P.E ?
0.4% (1/221)
M.I (Q or Non-Q wave)0.9% (2/221)
Procedural complications (VF)0.4% (1/221)Chest pain, Re-cath, TIMI-2 , Patent0.4% (1/221)
Re-Hospitalization2.3 % (5/221)
Re-Catheterization2.3 % (5/221)
TLR
TLR- PCI0.9% (2/221)Vessel and Aortic Root - Dissection 0.4% (1/221)
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Procedural ComplicationsProcedural Complications(per lesion)(per lesion)
Procedural ComplicationsProcedural Complications(per lesion)(per lesion)
Perforation0/279
Distal embolism 5/279 [1.8%]
Moderate side branch occlusion
10/279 [3.6%]
Thrombus formation1/279 [0.36%]
Dissections (> type C), no flow limiting dissection.
6/271 [2.2%]
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Cumulative MACE @ 19.2±11.2 mon. 187/221 [84.6%] pts.
ComplicationComplicationRateRate
Total MACETotal MACE4.9 % (11/221)4.9 % (11/221)
Death at day 10. Death at day 10.
non cardiac.non cardiac.0.4% (1/221)0.4% (1/221)
MI (Q or Non-Q wave)MI (Q or Non-Q wave)0.9% (2/221)0.9% (2/221)
Re-HospitalizationRe-Hospitalization18.6% (41/221)18.6% (41/221)
Re-CatheterizationRe-Catheterization15.4% (36/221)15.4% (36/221)
CABG [>6 months]CABG [>6 months]0.9% (2/221) [5.6%]0.9% (2/221) [5.6%]
Re-TLR/TVR - PCIRe-TLR/TVR - PCI2.7% (5/221) 2.7% (5/221) [13.8%][13.8%]
Vessel and aortic Vessel and aortic dissectiondissection
0.4% (1/221)0.4% (1/221)
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The The ‘AngioSculpt’‘AngioSculpt’ is highly is highly effectiveeffective for for the treatment of a the treatment of a broad spectrumbroad spectrum of of challenging challenging coronary artery lesionscoronary artery lesions
It is very useful to It is very useful to avoidavoid ““geographic geographic miss”miss” due to due to device slippagedevice slippage
A surprisingly low rate of TVR, A surprisingly low rate of TVR, no CARDIAC no CARDIAC relatedrelated DEATHDEATH and and no Late Stent no Late Stent THROMBOSISTHROMBOSIS was observed during long was observed during long term F/U in this study term F/U in this study
The The ‘AngioSculpt’‘AngioSculpt’ is highly is highly effectiveeffective for for the treatment of a the treatment of a broad spectrumbroad spectrum of of challenging challenging coronary artery lesionscoronary artery lesions
It is very useful to It is very useful to avoidavoid ““geographic geographic miss”miss” due to due to device slippagedevice slippage
A surprisingly low rate of TVR, A surprisingly low rate of TVR, no CARDIAC no CARDIAC relatedrelated DEATHDEATH and and no Late Stent no Late Stent THROMBOSISTHROMBOSIS was observed during long was observed during long term F/U in this study term F/U in this study
Conclusions IConclusions I
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NC balloonNC balloon usage was usage was reducedreduced by by 46%46% inin the lesions in whichthe lesions in which the the AngioSculptAngioSculpt was was successfully deployedsuccessfully deployed
Difficulty in device deliverability may be Difficulty in device deliverability may be anticipated in anticipated in severe, calcified lesions severe, calcified lesions associated with pronounced associated with pronounced vessel/lesion angulation vessel/lesion angulation (or when the (or when the IVUS catheter was unable to cross the IVUS catheter was unable to cross the lesion) lesion)
Deliverability enhancements including Deliverability enhancements including an improved crossing profile and an improved crossing profile and lubricious coating are in developmentlubricious coating are in development
NC balloonNC balloon usage was usage was reducedreduced by by 46%46% inin the lesions in whichthe lesions in which the the AngioSculptAngioSculpt was was successfully deployedsuccessfully deployed
Difficulty in device deliverability may be Difficulty in device deliverability may be anticipated in anticipated in severe, calcified lesions severe, calcified lesions associated with pronounced associated with pronounced vessel/lesion angulation vessel/lesion angulation (or when the (or when the IVUS catheter was unable to cross the IVUS catheter was unable to cross the lesion) lesion)
Deliverability enhancements including Deliverability enhancements including an improved crossing profile and an improved crossing profile and lubricious coating are in developmentlubricious coating are in development
Conclusions II