Mesh-Covered Stents for Carotid Intervention: Rationale ... · Mesh-Covered Stents for Carotid...

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Mesh-Covered Stents for Carotid Intervention: Rationale, Device Designs, Imaging, and Data to Date Piotr Musialek, MD DPhil Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland

Transcript of Mesh-Covered Stents for Carotid Intervention: Rationale ... · Mesh-Covered Stents for Carotid...

Page 1: Mesh-Covered Stents for Carotid Intervention: Rationale ... · Mesh-Covered Stents for Carotid Intervention: Rationale, Device Designs, Imaging, and Data to Date Piotr Musialek, MD

Mesh-Covered Stents for Carotid Intervention: Rationale, Device Designs, Imaging,

and Data to Date

Piotr Musialek, MD DPhil

Jagiellonian University Dept. of Cardiac & Vascular Diseases

John Paul II Hospital, Krakow, Poland

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Disclosure Statement of Financial Interest

• Grant/Research Support

• Consulting Fees/Honoraria

• ABBOTT

• ABBOTT, Balton, InspireMD, Medtronic

Within the past 12 months, I or my spouse/partner have had a financial

interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

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Rationale

P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

CAS (and CEA) are –and will remain–

emboli-generating procedures

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P. Musialek @ TCT 2015

Δ

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``

``

``

``

``

``

``

``

``

``

``

``

``

``

``

`

2/3CAS neuro

events(stroke, TIA)are POST-procedural

n = 3179 consecutive CAS patients

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

FREE CELL AREA drives CAS neurologic adverse events( and majority occur post-procedure )

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P. Musialek @ TCT 2015J. Schofer, P. Musialek et al. TCT 2014

Conventional Carotid Stent

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Conventional Carotid Stent

P. Musialek @ TCT 2015

Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of Barcelona

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P. Musialek @ TCT 2015

current best-in-classHybrid stent

current best-in-classClosed-cell stent

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P. Musialek @ TCT 2015

ANY data

on incidence of

PLAQUE PROLAPSE

in

conventional carotid stents ?

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Post-procedural PLAQUE PROLAPSE through conventional stent struts

De Donato et al. Eur J Vasc Endovasc Surg 2013;45:579-587.

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Conventional Carotid Stent

P. Musialek @ TCT 2015

Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of Barcelona

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P. Musialek @ TCT 2015J. Schofer, P. Musialek et al. TCT 2014

Conventional Carotid Stent

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P. Musialek @ TCT 2015

CREST

30 d

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P. Musialek @ TCT 2015

CRESTCREST

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P. Musialek @ TCT 2015

CRESTCREST

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P. Musialek @ TCT 2015

CRESTCREST

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P. Musialek @ TCT 2015

CRESTCREST

2015

we need to do better

+

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P. Musialek @ TCT 2015J. Schofer, P. Musialek et al. TCT 2014

Conventional Carotid Stent

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P. Musialek @ TCT 2015J. Schofer, P. Musialek et al. TCT 2014

Anti - Embolic Carotid Stent

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Device Designs

P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

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Device Designs

P. Musialek @ TCT 2015

n=3

Mesh-Covered Stents for Carotid Intervention

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Table by Terumo, used with permission

”Mesh” Stents

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P. Musialek @ TCT 2015

RoadSaver

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P. Musialek @ TCT 2015

RoadSaver

Casper

=

*Not available in the United States.

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P. Musialek @ TCT 2015

RoadSaver (Terumo) = Casper (MicroVena)

nitinol mesh INSIDE the nitinol frame

Images by Terumo / used with permission

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P. Musialek @ TCT 2015Images courtesy P. Pieniazek / Krakow and Terumo

RoadSaver: Push-Pull Stent Delivery System

re-sheathable up to 50% stent length release

CE Mark – January 2014

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P. Musialek @ TCT 2015

Open Cell NiTi Frame

Closed Cell 500 µm PTFE lattice on

outside of NiTi Frame

Permanently Bound CBAS Heparin on

all device surfaces

GORE® Carotid Stent

Courtesy WL Gore & Associates / by permission

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NB. The Gore carotid stent is not avialable outside the SCAFFOLD Study

Table by WL Gore & Associates / used with permission

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

The Gore Stent Delivery System

Hypotube(2.4 Fr)

Handle

Hub

Stent/Sheath(5Fr or 6Fr)

Attributes•Single handed delivery

•5Fr Introducer Sheath Compatible (White Tip)

•6Fr Introducer Sheath Compatible (Gray Tip)

•Hypotube Design

– Allows for complete closure of hemostatic valve

•135 cm Working Length

•30 cm Rx

RO Markers

NB. The Gore carotid stent is not avialable outside the SCAFFOLD Study

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P. Musialek @ TCT 2015*Not available in the United States; available in Europe and a number of other geographies

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P. Musialek @ TCT 2015

CGuard™ Embolic Prevention

Stent System

CE Mark – March 2014

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P. Musialek @ TCT 2015

CGuard™ Embolic Prevention

Stent System

Rx porttip

Images by InspireMD, used with permission

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P. Musialek @ TCT 2015

Pore Size

CGUARD™

ROADSAVER=CASPER

*165µm 375µm 500µm

1050µm 1900µmClosed cell stent Open cell stent

* Average in lesion at expanded state

GORE

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P. Musialek @ TCT 2015

Mesh position in re--lation to frame

Mesh material

Pore size

Stent frameclosed-cellNitinol

open-cellNitinol

open-cellNitinol

inside outside outside

Nitinol PTFE PET

PET = poliethylenteraphtalatPTFE = Polytetrafluoroethylene

Mesh structure braided inter-woven single-fiber knitted

375 µm 500 µm 150 - 180 µm

NameRoadSaveraka Casper

Gore®Carotid Stent

CGuard™Embolic Prevention Stent

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Datahistology / animal

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015PA Schneider VERVE 2014, animal data WL Gore / by permission

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P. Musialek @ TCT 2015

Histology and REM

after 6 months

Data by Terumo / used with permission

RoadSaver

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CGuard EPS 90 days / pig

InspireMD data / by permission

P. Musialek @ TCT 2015

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CGuard EPS 30 & 90 days/pig

P. Musialek @ TCT 2015

BMS = non mesh-covered CGuard nitynol frame; InspireMD data / used with permission

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Imagingangio

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Roadsaver / Casper

Angio/CAS images courtesy P. Pieniazek / Krakow

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Gore Carotid Stent

Angio/CAS images courtesy Dr. C. SchönholzP. Musialek @ TCT 2015

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CGuard™ EPS

Angio/CAS images P. MusialekP. Musialek @ TCT 2015

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ImagingIVUS

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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ImagingOCT

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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Courtesy of Dr. Max Amor, Essey les Nancy

RoadSaver

Data by Terumo / used with permissionP. Musialek @ TCT 2015

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CGuard™ EPS

Thrombotic material

T R A P P E D

between the stentMicroNET

and the vessel wall

Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of Barcelona P. Musialek @ TCT 2015

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CGuard™

EPS

P. Musialek @ TCT 2015

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ImagingCT

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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CGuard

P. Musialek @ TCT 2015

Images M.Urbanczyk / Z.Moczulski / M.Irzyk / P.BanyśJP2 Hospital, Krakow, Poland

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P. Musialek @ TCT 2015

CGuard

Images M.Urbanczyk / Z.Moczulski / M.Irzyk / P.BanyśJP2 Hospital, Krakow, Poland

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Evidencepublished

*

* full paper or journal abstract by October 2015

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

CGuard ™ embolic prevention stent

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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DW-MRI: the unforgiving testimony

of what you’ve done

to the TARGET ORGAN...

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

√

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P. Musialek @ TCT 2015J. Schofer, P. Musialek et al. TCT 2014

Anti - Embolic Carotid Stent

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P. Musialek @ TCT 2015J. Schofer, P. Musialek et al. TCT 2014

Anti - Embolic Carotid Stent

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CAS (and CEA) are –and will remain–

emboli-generating procedures

amenable toelimination

withmesh

P. Musialek @ TCT 2015

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CAS (and CEA) are –and will remain–

emboli-generating procedures

amenable toelimination

withMicroNet

+MicroNetprotection

duringstent healing!

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Prospective evaluation of All-comer peR-

cutaneous cArotiD revascularization In sympto-

matic and increased-risk asymptomatic carotid

artery stenosis using CGuard™ Micronet-covered

embolic prevention stent system:

The PARADIGM Study

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015

*Dept. of Cardiac & Vascular Dieases, John Paul II Hospital, Krakow, Poland; 10.2014–03.2015

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015

* Emboshield (n=7); FilterWire (n=14); Spider (n=25)** Gore FlowReversal (n=4) or flow reversal with MoMa (n=21)

(NB. mean flow reversal time was 6min 48s, from 5min 18s to 11min 2s) # ø 4.5mm (n=5); ø 5.0mm (n=36); ø 5.5mm (n=29); ø 6.0mm (n=1);§ 30mm in 51 lesions; 40mm in 18 lesions (2 other lesions required two stents each)

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P. Musialek @ TCT 2015EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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P. Musialek @ TCT 2015

n=71 arteries

in 68 patients

EuroPCR 2015 (www.europcr.com) and TCT-73 (2015)

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InformationProcedure - Relevant

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Re-sheathable ?

Crossing profile

Foreshortening

Stent placementaccuracy

Ability to eliminateresidual stenosis

Externally-analysedsystematicDW MRI study data

yes*

*up to 50% released length

no no

5F5F (smaller diam)6F (larger diam)

6F

yes no

– ++ N/D

N/DN/D yes

yesunknown unknown

unknown**

**probably not substantial

Name RoadSaveraka Casper

CGuard™Embolic Prevention Stent

# PARADIGM PCR2015 and TCT-73 N/D = not determined## CARENET JACC Intv 2015;8:1229

#

#

#

##

Gore®Carotid Stent

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Studieson-going

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

50% patient cohort recruitment threshold crossed

Roadsaver

√

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

GORE® Carotid Stent Clinical Study for the treatment of carotid Artery stenosis in patients at increased risk For adverse

events From carOtid enDarterectomy

The Gore SCAFFOLD Clinical Study

• Number of Subjects312 subjects (max 40 at each site)

• Primary EndpointComposite of Major Adverse Events (MAE) defined as death,

any stroke, or myocardial infarction through 30 days post indexprocedure plus ipsilateral stroke between 31 days and 1 year

*All primary endpoint events will be determined by the study Clinical Events Committee

• 50% patient cohort recruitment threshold crossed

• Data expected 2017

Study data courtesy WL Gore & Associates

PIs: P.A. Schneider and W.A. Gray

√

NCT # 01901874

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Announced:

Planned enrollment: n = 200 patients

Primary endpoint: clinical – MAE

death/stroke/MI ≤ 30 days

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

PARADIGM – Extend

(aka PARADIGM-101)

PI: P. Musialek / Krakow

subacute stroke

√

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Unknowns

remaining

P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

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Remaining Unknowns (1)

P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

Is there a product/design-specific ”gradient”in the embolic prevention efficacy?

.

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P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

Is there a product/design-specific ”gradient”in the embolic prevention efficacy?

.Remaining Unknowns (1)

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P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

Is there a product/design-specific ”gradient”in the embolic prevention efficacy?

.Remaining Unknowns (1)

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P. Musialek @ TCT 2015

Mesh-Covered Stents for Carotid Intervention

Large-scale (muli-center, multi-hundred patient),controlled clinical endpoint data?

.

Long-term treatment durability / ’no restenosis’ proof.

Role in open (CEA) vs. endo (CAS) balance

Role in primary stroke prevention

.

.

NB. sofar –no worryingsignal

Remaining Unknowns (2)

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Conclusions

Mesh-Covered Stents for Carotid Intervention

P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Clinical evidence in October 2015…1 peer-reviewed, published clinical study

- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)

.CARENET, JACC Intv 2015;8:1229-1234

Mesh-Covered Stents for Carotid Intervention

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P. Musialek @ TCT 2015

Clinical evidence in October 2015…1 peer-reviewed, published clinical study

- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)

several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints

- 1 with full 30-day data available in all-comers(others underway or planned)

.CARENET, JACC Intv 2015;8:1229-1234

.

Mesh-Covered Stents for Carotid Intervention

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P. Musialek @ TCT 2015

Clinical evidence in October 2015…1 peer-reviewed, published clinical study

- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)

several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints

- 1 with full 30-day data available in all-comers(others underway or planned)

> 300pts single-arm clinical-endpoint studydue to report in 2017

.CARENET, JACC Intv 2015;8:1229-1234

.

.

Mesh-Covered Stents for Carotid Intervention

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P. Musialek @ TCT 2015

Clinical evidence in October 2015…1 peer-reviewed, published clinical study

- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)

several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints

- 1 with full 30-day data available in all-comers(others underway or planned)

> 300pts single-arm clinical-endpoint studydue to report in 2017

.CARENET, JACC Intv 2015;8:1229-1234

.

.mesh-covered carotid stents have individual, specificcharacteristics but no comparative studies…

(and such may never be conducted)

.

Mesh-Covered Stents for Carotid Intervention

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P. Musialek @ TCT 2015

Clinical evidence in October 2015…1 peer-reviewed, published clinical study

- multicenter, single-arm- DWI controlled (24-48h, 30d, external analysis)

several moderately-sized investigator-initiatedsingle arm studies with clinical endpoints

- 1 with full 30-day data available in all-comers(others underway or planned)

> 300pts single-arm clinical-endpoint studydue to report in 2017

.CARENET, JACC Intv 2015;8:1229-1234

.

.mesh-covered carotid stents have individual, specificcharacteristics but no comparative studies…

(and such may never be conducted)

.

Mesh-Covered Stents for Carotid Intervention

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of Barcelona P. Musialek @ TCT 2015

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P. Musialek @ TCT 2015

Embolic-Prevention Stent Image Courtesy Dr Juan Rigla, MD PhDPerceptual Imaging Lab, Univerity of Barcelona P. Musialek @ TCT 2015

Carotid Revascularization2015 R E A L I T Y +

CA

S 2

01

0 V

ISIO

N


Carotid Artery Disease - University of Toledo Handout.pdf2010/02/26  · stroke and carotid stenosis (NASCET patient) Symptomatic Carotid Disease Vascular Emergency! Symptomatic carotid

Carotid Artery Disease - University of Toledo Handout.pdf2010/02/26  · stroke and carotid stenosis (NASCET patient) Symptomatic Carotid Disease Vascular Emergency! Symptomatic carotid

Why are drug-eluting stents safer than bare-metal stents?

Why are drug-eluting stents safer than bare-metal stents?

Air Way Stents

Air Way Stents

Stroke Treatment of Carotid Artery Disease - Carotid Artery Disease Fin… · Carotid Artery Disease 20 to 30% of strokes are caused by atherosclerotic carotid artery disease Carotid

Stroke Treatment of Carotid Artery Disease - Carotid Artery Disease Fin… · Carotid Artery Disease 20 to 30% of strokes are caused by atherosclerotic carotid artery disease Carotid

βιοαπορροφησιμα Stents

βιοαπορροφησιμα Stents

Carotid Artery Disease - The Vascular Groupalbanyvascular.com/.../uploads/2015/04/Carotid-Artery-Disease.pdf · TREATMENT OF CAROTID ARTERY DISEASE ... CAROTID ARTERY STENTING Stenting

Carotid Artery Disease - The Vascular Groupalbanyvascular.com/.../uploads/2015/04/Carotid-Artery-Disease.pdf · TREATMENT OF CAROTID ARTERY DISEASE ... CAROTID ARTERY STENTING Stenting

Stents btk2

Stents btk2

Angioplasty’s Fight against Restenosis: Drug Eluting Stents & Bare Metal Stents.

Angioplasty’s Fight against Restenosis: Drug Eluting Stents & Bare Metal Stents.

Stents Angioplasty carotid - Postgraduate Medical Journal · severe carotid stenosis of 70% or more treated medically was significantly reducedbysurgery. However, surgeryhas disadvanges

Stents Angioplasty carotid - Postgraduate Medical Journal · severe carotid stenosis of 70% or more treated medically was significantly reducedbysurgery. However, surgeryhas disadvanges

Stents in Gastrointestinal Endoscopy - IntechOpen · Stents in Gastrointestinal Endoscopy 117 2.2 Self-expanding stents Although simple plastic stents still have a role in biliary

Stents in Gastrointestinal Endoscopy - IntechOpen · Stents in Gastrointestinal Endoscopy 117 2.2 Self-expanding stents Although simple plastic stents still have a role in biliary

Bioabsorbable Stents for Adults with Acute Coronary ... · coronary vascular stents (or scaffolds) such as bare metal stents (BMS), and drug eluting stents (DES). 8 Coronary vascular

Bioabsorbable Stents for Adults with Acute Coronary ... · coronary vascular stents (or scaffolds) such as bare metal stents (BMS), and drug eluting stents (DES). 8 Coronary vascular

STENTS - Minia

STENTS - Minia

Urology - Marflo · Urology Program. 4 5 Ureteral Stents - Standard Double-J - Multiloop Stents Ureteral Stents Standard Double-J and Multiloop Stents ... the potential of trauma.

Urology - Marflo · Urology Program. 4 5 Ureteral Stents - Standard Double-J - Multiloop Stents Ureteral Stents Standard Double-J and Multiloop Stents ... the potential of trauma.

NSPR Corporate Presentation July 2019.pptx - Read-Only · • The balance are treated with conventional carotid stents (CAS) with an average of 1.05 stents/procedure • At a price

NSPR Corporate Presentation July 2019.pptx - Read-Only · • The balance are treated with conventional carotid stents (CAS) with an average of 1.05 stents/procedure • At a price

Stents biorreabsorbibles

Stents biorreabsorbibles

Enteral stents

Enteral stents

Comparison of Drug-Eluting Stents with Bare Metal Stents In

Comparison of Drug-Eluting Stents with Bare Metal Stents In

Stents traqueobronquiales

Stents traqueobronquiales

DETERMINANTS OF ATHEROSCLEROSIS IN …...IV subclinical atherosclerosis 1.8.5.1 Rationale for the use of carotid ultrasound 34 1.8.5.2 The difference between intimal-medial thickness

DETERMINANTS OF ATHEROSCLEROSIS IN …...IV subclinical atherosclerosis 1.8.5.1 Rationale for the use of carotid ultrasound 34 1.8.5.2 The difference between intimal-medial thickness

Airway stents

Airway stents