Slide 1: CARENET: CGuard carotid stent safety and efficacy study
A prospective, multicentre study on the safety and efficacy of a novel mesh-covered carotid stent in patients with symptomatic and asymptomatic carotid artery stenosis: the CGuard CARotid embolic protection using microNET trial (CARENET) Joachim Schofer (PI) Piotr Musialek (Co-PI) On behalf of the C
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: Late Embolization – The Unmet Need
Late Embolization – The Unmet Need 2/3 MACCE events occur post-procedure Bosiers et al. Eur J Vasc Endovasc Surg 2007;33
Slide 4: Post Procedural Plaque Prolapse Through Conventional Stent Struts
Post Procedural Plaque Prolapse Through Conventional Stent Struts 30.7% 1/3 stents = Precise 2/3 stents = Carotid Wallstent No current stent protects against late embolization Suzuki M et al. ESC 2014 Eur Heart J. 2014;35(Abstr Suppl):178
Slide 5: CGuard Carotid Embolic Prevention System Specifications
CGuardTM Carotid Embolic Prevention System Specifications Device Features Stent type Nitinol Self-Expanding open cell 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
Slide 6: CGuard CARENET Trial Design
CGuardTM CARENET (CARotid Embolic protection using microNET) Trial Design Study Design: • Prospective, multi-center, open label, single arm, non-randomized clinical trial in patients with symptomatic and asymptomatic carotid artery stenosis Objectives: • To evaluate the periprocedural safety and
Slide 7: CGuard CARENET Trial Design: Population and Endpoints
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: CARENET Procedural Results
CARENET Procedural Results (n=30) Femoral access 100% (30) - Left ICA 33.3% (10) - Right ICA 66.6% (20) Protection used -Distal filter protection 96.6% (29) -Proximal balloon protection 3.4% (1) Pre dilatation 70.9% (22) Post dilatation 77.4% (24) Procedure success 100% (30) Diameter stenosis (%) 79
Slide 10: CARENET Clinical Events
CARENET Clinical Events 30 days 6 months (n=30) (n=28*) MACCE (MI, stroke, death) (0) 0.0% (1) 3.6% MI (0) 0.0% (0) 0.0% Stroke (0) 0.0% (0) 0.0% Death (0) 0.0% (1) 3.6% • Comparative data from other CAS trials include higher 30 day and 6 month MACCE rates: 30 days** 6 months† (14 trials, 5255 patie
Slide 11: CARENET DW-MRI Analysis
CARENET DW-MRI Analysis DW-MRI analysis @ 48 hours, n=27* 70 CARENET 0.4 PROFI 60 66.2 0.35 0.375 new ipsilateral lesions (cm3) new ipsilateral lesions (%) 0.3 50 0.25 incidence 40 volume 0.2 37 30 0.15 20 0.1 10 0.05 0.039 0 0 DW-MRI analysis @ 30 days, n=25** Incidence of ipsilateral lesions 4.0%
Slide 12: CARENET Ultrasound PSV scatter plot
CARENET Ultrasound PSV scatter plot >70% stenosis 300 250 50-70% stenosis 200 PSV (cm/sec) 150 30-50% stenosis 100 30% stenosis 50 0 30D 6M
Slide 13: Conclusions
Conclusions • CARENET trial met primary endpoint of zero MACE (no death, stroke, and MI) at 30 days • The procedural success was 100% • Incidence of new ipsilateral lesions at 48 hours was reduced by almost half compared to published data, and volume was reduced almost 10-fold. • All but one lesion
Slide 14: Thank You
2015 Thank You