Slide 1: The CARENET-Trial
Evaluation of PET Mesh Covered Stent in Patients with Carotid Artery Disease The CARENET-Trial (CARotid Embolic protection using microNET) Joachim Schofer (PI) Piotr Musialek (Co-PI) On behalf of the CARENET Investigators Joachim Schofer, MD,PhD, Hamburg University CardiovascularCenter, Hamburg Germ
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest 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 • Grant/Research Support • InspireMD
Slide 3: Conventional Carotid Stent
Conventional Carotid Stent Plaque protrusion may lead to early and late distal embolization
Slide 4: DW-MRI post CAS
DW-MRI post CAS Mean total lesion area 50 40 30 mm2 20 10 0 3,5 h 18 h Schofer J et al, JACC Cardiovasc interv 2008
Slide 5: CGuard Carotid Embolic Prevention System Specifications
CGuardTM Carotid Embolic Prevention System Specifications Device Features Stent type Nitinol Self-Expanding MicroNet Aperture Size 150-180µ Guidewire 0.014” Foreshortening <10% Sizes Diameter( 6mm-10mm) x Length (20mm – 60mm) Delivery System (OD) 6F (2.1mm) CE marked. Not approved for sale in the US
Slide 6: CGuard CARENET Trial Design
CGuardTM CARENET (CARotid Embolic protection using microNET) Trial Design Study Design: • Prospective, multi-center, multi-specialty, international, open label, single arm, non-randomized clinical trial in patients with symptomatic and asymptomatic carotid artery stenosis Objectives: • To evalua
Slide 7: CGuard CARENET Trial Design
CGuardTM CARENET (CARotid Embolic protection using microNET) Trial Design Study Population: • Symptomatic pts (w/ history of a transient ischemic attack, stroke, or amaurosis fugax within the last 6 mos on the ipsilateral side) w/carotid stenosis ≥ 50% • Asymptomatic pts w/ carotid stenosis ≥ 80%
Slide 8: Baseline Characteristics
Baseline Characteristics (n=30) Age 71.6 ±7.6 Male 63.4% Symptomatic 33.3% (10) BMI (kg/m2) 26.4 ± 3.9 Hypertension 83.3% (25) Dyslipidemia 90% (27) Diabetics 23.3% (7) Smoker: Current 13.4% (4) Former 36.6% (11) Prior MI 26.7% (8) Prior TIA 13.3% (4)
Slide 9: Procedure Results
Procedure Results Femoral access 100% (30) Target vessel Left ICA 33.3% (10) Right ICA 66.6% (20) Protection used 100% Distal protection 96.6% (29) Proximal protection 3.4% (1) Pre dilatation 70.9% (22) Post dilatation 77.4% (24) Post dilatation Pressure (ATM) 13.6 ±4.5 Device success 100% (30) Sten
Slide 10: Pre & Post Procedure Carotid Angiogram in Patient with right ICA Stenosis
Pre & Post Procedure Carotid Angiogram in Patient with right ICA Stenosis
Slide 11: Clinical Outcomes
Clinical Outcomes Post Procedure Discharge 30 days Device success 100% NA NA MACE 0% 0% 0% Death 0% 0% 0% MI 0% 0% 0% Stroke 0% 0% 0%
Slide 12: Angiographic Assessment
Angiographic Assessment Baseline Final Lesion location (internal) 100% NA Lesion length (mm) 16.94±4.7 NA RVD (mm) 6.18 5.89 MLD (mm) 1.25 4.82 Diameter stenosis (%) 79.9%±5.0% 16.9%±6.5% (in stent) ECA stenosis (%) 18.0% 22.1% TIMI flow in ECA Normal 100.0% 100.0%
Slide 13: CARENET with Distal Protection DW-MRI @ 24-48 hrs
CARENET with Distal Protection DW-MRI @ 24-48 hrs CARENET CGuard with only Distal EPD (N=26*) Incidence of New Lesions 46% Lesions (per patient) 1.62 ±2.68 Volume (per patient) 0.061 ±0.11 cm3 • *3 pts unable to undergo MRI (1 = pacemaker; 2 = claustrophobia) • 1 pt with proximal protection had 78 n
Slide 14: CARENET Comparison DW-MRI @ 24-48 hrs
CARENET Comparison DW-MRI @ 24-48 hrs CARENET PROFI1 ICSS2 (Filter group) (Filter group) (Filter group) N=26 N=31 N=37 Incidence of New Lesions 48% 87% 73% Avg Lesion Volume 0.06 cm3 0.59 cm3 NA 1 JACC, April 2012 2 Lancet, March 2010
Slide 15: Conclusions
Conclusions • CARENET trial demonstrated the safety of the CGuardTM Technology with zero MACCE at 30 days • The procedural success was 100% • Compared to published DW-MRI data of non-mesh covered carotid stents, the incidence of new ischemic lesions was reduced by almost 50% and the average lesion v