Slide 1: PARADIGM Study: all-comer carotid revascularization using CGuard MicroNet-covered stent
P rospective evaluation of A ll - comer pe R cutaneous c A roti D revascularization I n symptomatic and increased - risk asymptomatic carotid artery stenosis using C G uard ™ M icronet - covered embolic prevention stent system : The PARADIGM Study Jagiellonian University Dept. of Cardiac & Vascular
Slide 2: PARADIGM Study: all-comer carotid revascularization using CGuard MicroNet-covered stent
P rospective evaluation of A ll - comer pe R cutaneous c A roti D revascularization I n symptomatic and increased - risk asymptomatic carotid artery stenosis using C G uard ™ M icronet - covered embolic prevention stent system : The PARADIGM Study Jagiellonian University Dept. of Cardiac & Vascular
Slide 3: PARADIGM Study: all-comer carotid revascularization using CGuard MicroNet-covered stent
P rospective evaluation of A ll - comer pe R cutaneous c A roti D revascularization I n symptomatic and increased - risk asymptomatic carotid artery stenosis using C G uard ™ M icronet - covered embolic prevention stent system : The PARADIGM Study Jagiellonian University Dept. of Cardiac & Vascular
Slide 4: PARADIGM Study: all-comer carotid revascularization using CGuard MicroNet-covered stent
P rospective evaluation of A ll - comer pe R cutaneous c A roti D revascularization I n symptomatic and increased - risk asymptomatic carotid artery stenosis using C G uard ™ M icronet - covered embolic prevention stent system : The PARADIGM Study Jagiellonian University Dept. of Cardiac & Vascular
Slide 5: Potential conflicts of interest
Potential conflicts of interest Speaker's name: Piotr Musialek I have the following potential conflicts of interest to report: Consult ing / Research Support / Speaker Bureau ABBOTT VASCULAR Balton Ltd InspireMD MEDTRONIC NB. Research in this presentation is not industry - funded
Slide 6: CAS: State-of-the-art and horizon
CAS: State - of - the - art and horizon
Slide 7: CAS (and CEA) are and will remain emboli-generating procedures
CAS (and CEA) are – and will remain – emboli - generating procedures
Slide 8: 2/3 CAS neuro events are post-procedural
2/3 CAS neuro events ( stroke , TIA) are POST - procedural n = 3179 consecutive CAS patients
Slide 9: Free cell area drives CAS neurologic adverse events
FREE CELL AREA drives CAS neurologic adverse events ( and majority are those during stent healing ! )
Slide 10: CAS using conventional carotid stents in high-risk lesions
J. Schofer, P. Musialek et al. TCT 2014 CAS using conventional carotid stents in high - risk lesions
Slide 11: Current best-in-class hybrid stent and closed-cell stent
current best - in - class Hybrid stent current best - in - class Closed - cell stent
Slide 12: Post-procedural embolization
Post-procedural Embolization siti conventional] carotid stents DW-MRI post CAS Mean total lesion area 40 35 — 30 mm? oe 0) 15 10 5 (0) 18h 3,5h ‘Schoter Jet al, JACC Cardiovasc interv 2008. otct204 oe
Slide 13: CAS using conventional carotid stents in high-risk lesions
J. Schofer, P. Musialek et al. TCT 2014 CAS using conventional carotid stents in high - risk lesions
Slide 14: CGuard embolic prevention system
CGuard ™ embolic prevention system P Musialek @ ePCR 2015
Slide 15: CGuard Carotid Embolic Prevention System specifications
CGuardtm Carotid Embolic Prevention System System specifications Stent type Nitinol – self expanding Micronet aperture size 150 - 180 ; m Guidewire 0.014” Sizes - Diameter - Length 6 - 10mm 20 - 60mm CE Mark – March 2014
Slide 16: Objective
Objective to evaluate feasibility and outcome of routine anti - embolic stent system use in unselected, consecutive patients referred for carotid revascularization (‘ all - comer ’ study ) .
Slide 17: Methods
Methods : academic cardio - vascular centre investigator - initiated study not industry - funded all - comer patient inclusion ( six month referral sample ) all referrals tracked routine consultation and management pathways qualitative and quantitative lesion & stent evaluation investigator - indepe
Slide 18: Methods: The CAS Procedure
Methods : The CAS Procedure EPD use mandatory ; EPD selection according to the ‘ Tailored CAS’ algorithm Liberal postdilatation accepted in order to maximize potential for ‘ endovascular full reconstruction ’ ( minimizing residual stenosis ) NB. 1. DWI evidence of effective MicroNet prevention again
Slide 19: CARENET vs PROFI: DW-MRI analysis
CARENET vs PROFI : DW - MRI analysis K. Bijuklic et al. JACC , 2012;59 :1383 - 9. DW - MRI analysis @ 48 hours Filter - protected CAS procedures J. Schofer, P. Musialek et al. JACC Intv 2015 (in press) 34.6 87.1 0 10 20 30 40 50 60 70 80 90 100 INCIDENCE new ipsilateral lesions (%) n=27 n=31 Convent
Slide 20: CGuard embolic prevention system
CGuard ™ embolic prevention system P Musialek @ ePCR 2015
Slide 21: CARENET vs PROFI: DW-MRI analysis
CARENET vs PROFI : DW - MRI analysis DW - MRI analysis @ 48 hours Filter - protected CAS procedures n=27 n=31 0.04 0.59 -0.1 6E-16 0.1 0.2 0.3 0.4 0.5 0.6 Conventional Carotid stent (hybrid) V O L U M E new ipsilateral lesions (mL) J. Schofer, P. Musialek et al. JACC Intv 2015 (in press) K. Bijuklic
Slide 22: Endpoints
Endpoints : feasibility of endovascular Tx in unselected referrals device success ( able to deliver + implant + <30% DS) procedure success ( device success w/o clinical compl .) clinical efficacy : MACNE ( death / stroke /MI ) in - stent velocities (Duplex) PARADIGM . . . . . ( external neurologist
Slide 23: Asymptomatic patients treated only if at increased stroke risk
PARADIGM . . ASYMPTOMATIC patients treated interventionally only if at stroke risk established lesion - level increased - risk crieria used : – thrombus - containing – tight , near - occlusive – documented progressive – irregular and/ or ulcerated – contralteral ICA occlusion / stroke – asymptomatic
Slide 24: Investigator-independent external angiographic analysis
PARADIGM: investigator – independent external angiographic analysis Methods ( cont’d ) external study data verification external statistical analysis . . .
Slide 25: Study Flow Chart (1)
Study Flow Chart (1) 97 carotid stenosis patient referrals ( external >> internal ) *Dept. of Cardiac & Vascular Dieases , John Paul II Hospital , Krakow , Poland; 10.2014 – 03.2015 *
Slide 26: Study Flow Chart (1): Neuro-Vascular Team
Study Flow Chart (1) 97 carotid stenosis patient referrals ( external >> internal ) Neuro - Vascular Team Neurologist Interventional Angiologist Vascular Surgeon Cardiologist *Dept. of Cardiac & Vascular Dieases , John Paul II Hospital , Krakow , Poland; 10.2014 – 03.2015 * . . . . Gupta K et al. A
Slide 27: Study Flow Chart (1): patients for and not for revascularization
Study Flow Chart (1) 97 carotid stenosis patient referrals ( external >> internal ) Neuro - Vascular Team for carotid revascularization 73 patients NOT for carotid revascularization 24 patients Neurologist Interventional Angiologist Vascular Surgeon Cardiologist n= 19: l esion increased risk and/ or
Slide 28: Study Flow Chart (2)
Study Flow Chart (2) 73 Patients for carotid revascularization CAS in n= 67 Patients ( bilateral in 3) CEA in n= 5 Patients CAS + CEA in n= 1 Patient (LICA - CEA and RICA - CAS) (92%) (1%) (7%) n = 1 eGRF 14 => no contrast n = 1 extreme access tortuousity n = 1 severe aortic valve disease + calcific
Slide 29: Study Flow Chart (2)
Study Flow Chart (2) 73 Patients for carotid revascularization CAS in n= 67 Patients ( bilateral in 3) CEA in n= 5 Patients CAS + CEA in n= 1 Patient (LICA - CEA and RICA - CAS) (92%) (1%) (7%) n = 1 eGRF 14 => no contrast n = 1 extreme access tortuousity n = 1 severe aortic valve disease + calcific
Slide 30: Clinical characteristics of study patients (n=68)
Clinical characteristics of study patients (n=68) age , mean ± SD ( min – max ) 69 ± 7 ( 55 – 83 ) male, % (n) 66 % (45) symptomatic, % (n) symptomatic 14 days, % (n) acutely symptomatic (emergent CAS) , % (n) 53 % (36) 28 % (19) 9 % (6) index lesion (CAS) , % (n) RICA LICA RICA+LICA 52 % (35) 44 %
Slide 31: PARADIGM: Results (1)
Percutaneous treatment 100% using the intended MicroNet - covered embolic prevention stent system CGuard ( ie , no other stents used during the study period) PARADIGM: Results (1) Transient Dopamine infusion 1 9 % (n=14) Device success 100% Debris in EPD 18% ( n=13 ) Procedure success 100% Access si
Slide 32: Index lesion qualitative characteristics
Index lesion qualitative characteristics (n=71 lesions) All (n=71) Symptomatic (n=37) Asymptomatic (n=34) p thrombus, % (n) 15 % (11) 24 % (9) 6% (2) 0.025 near occl./string, % (n) 21 % (15) 30 % (11) 12% (4) 0.084 proggressive*, % (n) 27 % (19) 11 % (4) 44% (15) 0.003 ulcerated, % (n) 41 % (29) 46
Slide 33: Index lesion quantitative characteristics
Index lesion quantitative characteristics (n=71 lesions ) All (n=71 lesions) Symptomatic n=37 Asymptomatic n=34 p Before CAS PSV, m/s 3.8 ± 1.3 3.7 ± 1.1 3.8 ± 1.5 0.862 EDV, m/s 1.3 ± 0.7 1.4 ± 0.6 1.3 ± 0.8 0.687 Diameter stenosis % (QA) 82 ± 9 79 ± 9 84 ± 9 0.021 CAS EPD type Proximal* Distal** 3
Slide 34: PARADIGM: Results (4)
Death/stroke/MI @ 48h 0% Death/stroke/MI @ 30d 0% PARADIGM: Results (4) . .
Slide 35: PARADIGM: Results (5)
PARADIGM: Results (5) PSV (m/s) baseline CGuard 30 days
Slide 36: PARADIGM: Results (4)
Death/stroke/MI @ 48h 0% Death/stroke/MI @ 30d 0% PARADIGM: Results (4) . .
Slide 37: PARADIGM: Conclusions
>90% all - comer carotid artery stenosis patients , including >50% symptomatic presentations , can be treated endovascularly using the MicroNet - covered embolic prevention stent system CGuard use of the MicroNet - covered embolic prevention stent system enables ‘ endovascular reconstruction ’ of th
Slide 38: CGuard follow-up
CGuard 5 month follow - up CGuard Piotr Musialek @ ePCR 2015
Slide 39: CGuard follow-up imaging at months
RCCA & RICA LICA CGuard Piotr Musialek @ ePCR 2015 @ 5 months Wallstent Precise
Slide 40: CGuard: Endovascular solution for all-comers
C Guard : Endovascular Solution For All - comers 61 yo symptomatic LICA 72 yo asymptomatic RICA Piotr Musialek @ ePCR 2015 Endovascular Reconstruction of the Carotid Bifurcation
Slide 41: Embolic events amenable to elimination with mesh
amenable to elimination with mesh Stent placement Stent relaese CAS (and CEA) are – and will remain – emboli - generating procedures P Musialek @ ePCR 2015
Slide 42: CGuard embolic prevention stent system features
C Gu ard embolic prevention stent system Compatible with ALL EPD types Deliverable in hard - access anatomies Optimal visibility Reliable, predictable, and extremely precise placement No indication of foreshortening Radial strength sufficient for v. hard lesions . . . . . . √ √ √ √ √ √ Piotr Musiale
Slide 43: Full respect of the carotid bifurcation anatomy
Full respect of the carotid bifurcation anatomy - > ‘ endovascular anatomic reconstruction ’ Optimal performance across all lesion subsets (including high calcium/thrombus/string) . . √ √ C Gu ard embolic prevention stent system Piotr Musialek @ ePCR 2015 ‘ The most OPEN of open - cell stent designs