Slide 1: The CARENET all-comer trial using the CGuard carotid embolic prevention stent: 6 month data
Piotr Musialek , MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital , Krakow , Poland 2015 The CARENET all - comer trial using the CGuard ™ micronet - covered carotid embolic prevention stent 6 month data
Slide 2: Disclosures
ysl 2015 Disclosures Research / Consulting / Speaker Beureau Abbott Cardio3 Biosciences InspireMD Medtronic
Slide 3: CAS: State-of-the-art and horizon
CAS: State - of - the - art and horizon
Slide 4: CAS (and CEA) are and will remain emboli-generating procedures
CAS (and CEA) are – and will remain – emboli - generating procedures 2015
Slide 5: 2/3 CAS neuro events are post-procedural
2/3 CAS neuro events ( stroke , TIA) are POST - procedural n = 3179 consecutive CAS patients 2015
Slide 6: Free cell area drives CAS neurologic adverse events
FREE CELL AREA drives CAS neurologic adverse events ( and majority are those during stent healing ! ) 2015
Slide 7: Conventional hybrid stent vs closed-cell stent
conventional best - in - class Hybrid stent (‘open - close - open’) conventional best - in - class Closed - cell stent P Musialek , LINC 2015 2015
Slide 8: J. Schofer, P. Musialek et al. TCT 2014 K. Mathias , TCT 3
J. Schofer, P. Musialek et al. TCT 2014 K. Mathias , TCT 2013
Slide 9: Data on incidence of plaque prolapse in conventional carotid stents?
ANY data on incidence of PLAQUE PROLAPSE in conventional carotid stents ? P Musialek , LINC 2015 2015
Slide 10: Post-procedural plaque prolapse through conventional stent struts
Post - procedural PLAQUE PROLAPSE through conventional stent struts 30.7 % Suzuki M et al. ESC 2014 Presentation www.escardio.org Eur Heart J . 2014;35(Abstr Suppl):178 1/3 stents = Precise 2/3 stents = Carotid Wallstent Images : Dr M. Suzuki ESC 2014 www.escardio.org 2015
Slide 11: DW-MRI: the unforgiving testimony of what you've done to the target organ
DW - MRI : the unforgiving testimony of what you’ve done to the TARGET ORGAN... P Musialek , LINC 2015 2015
Slide 12: 48h after LICA-CAS: The power of DW-MRI
48h after LICA - CAS The Power of DW - MRI ... 0.037 cm³ 0.039 cm³ M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland 2015
Slide 13: Post-procedural embolization with carotid stents
Post-procedural Embolization with carotid stents DW-MRI post CAS Mean total lesion area 40 35 ea 30 25 mm? 20 15 10 5 0 18h 35h ‘Schofer Jet al, JACC Cardiovasc interv 2008 otct24
Slide 14: CGuard embolic prevention stent
CGuard ™ embolic prevention stent P Musialek , LINC 2015
Slide 15: CGuard Carotid Embolic Prevention System
CGuard™ – 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 2015
Slide 16: Evaluation of PET Mesh Covered Stent in Patients with Carotid Artery Disease: 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 (Pl) Piotr Musialek (Co-Pl) On behalf of the CARENET Investigators Joachim Schofer, MD,PhD, Hamburg University CardiovascularCenter, Hamburg Germ
Slide 17: CARENET – Study Design
CARENET – S tudy D esign Study Design: Prospective, multi - center, single arm , all - comer Objectives: To evaluate the periprocedural safety and efficacy of the CGuard stent in the treatment of carotid lesions in thirty consecutive patients with symptomatic and asymptomatic carotid artery stenosis
Slide 18: CARENET – Baseline Characteristics
2015 CARENET – Baseline C haracteristics Baseline characteristics CARENET (n=30) Age (years) 71.6 “ 7.6 Male 63.4% Symptomatic 33.3 (10) BMI 26.4 ± 3.9 Hypertension 83.3% (25) Hyperlipidemia 90% (27) Diabetes mellitus 23.3% (7) Cigarette smoking, current 13.4% (4) Prior myocardial infarction 26.7% (
Slide 19: CARENET – Procedure Results
2015 CARENET – Procedure R esults Target vessel - Left ICA - Right ICA 33.3% (10) 66.6% (20) Protection used - Distal filter protection - Proximal balloon protection 96.6% (29) 3.4% (1) Pre dilatation 70.9% (22) Post dilatation 77.4% (24) Post dilatation Pressure (ATM) 13.6 “ 4.5 Stent deployed 100%
Slide 20: CARENET – Procedure Results: Angiographic assessment
Angiographic assessment, CARENET (n=30) Baseline Final Lesion location in left/right ICA 33/67% - Lesion length [ mm ] 16.94 “ 4.7 - MLD [ mm ] 1.25 “ 0.34 4.82 “ 0.60 % Diameter stenosis 79.9 “ 5.0 16.9 “ 6.5 TIMI III flow in the ECA 100% 100% J. Schofer, P. Musialek et al. 2015 (manuscript at revi
Slide 21: CARENET Clinical Events
CARENET Clinical Events 30 days 6 months (n=30) (n=28*) MACCE (MI, stroke, death) 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 30 days** 6 months* (14 trials) (3 trials) MACCE (MI, stroke, death) See patient fluxogram Trials included in
Slide 22: DW-MRI: the unforgiving testimony of what you've done to the target organ
DW - MRI : the unforgiving testimony of what you’ve done to the TARGET ORGAN... P Musialek , LINC 2015 2015
Slide 23: CGuard embolic prevention stent
CGuard ™ embolic prevention stent P Musialek , LINC 2015
Slide 24: CARENET DW-MRI: baseline, 24h and 30 days after CAS
Baseline 24h after CAS Prior to CAS 30 days after CAS DWI Flair DWI Flair No new CAS - related lesions No new lesions between 24h and 30d CARENET PJ, 03 - 007 (Krakow) LICA 2015 External, blinded CoreLab MRI image analysis and quantification (USA)
Slide 25: CARENET DW-MRI analysis
CARENET DW - MRI analysis DW - MRI analysis @ 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS † (n=56) Incidence of new ipsilateral lesions 37 . 0 % 66 . 2 % 68.0% Average lesion volume (cm 3 ) 0.039 ± 0.08 0.375 - Maximum lesion volume (cm 3 ) 0.445 Bijuklic et al. JACC , 2012 ; Bonati et. al, Lanc
Slide 26: CARENET DW-MRI analysis
CARENET DW - MRI analysis DW - MRI analysis @ 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS † (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) 0.039 0.375 - Maximum lesion volume (cm 3 ) 0.445 Bijuklic et al. JACC , 2012 ; Bonati et. al, Lancet Neurol 201
Slide 27: CARENET – DW-MRI analysis
CARENET – DW - MRI analysis DW - MRI analysis @ 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS † (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) 0.039 ± 0.08 0.375 - Maximum lesion volume (cm 3 ) 0.445 ICSS Bijuklic et al. JACC , 2012 ; Bonati et. al, Lan
Slide 28: CARENET: DW-MRI analysis
2015 CARENET : DW - MRI analysis * see patient fluxogram Bijuklic et al. JACC , 2012;59 DW - MRI analysis @ 48 hours *
Slide 29: CARENET vs. PROFI DW-MRI analysis
2015 CARENET vs. PROFI DW - MRI analysis @ 48 hours* 37 34.6 45.2 87.1 0 10 20 30 40 50 60 70 80 90 100 incidence new ipsilateral lesions (%) CARENET (distal and proximal) CARENET (distal only) PROFI proximal balloon PROFI filter protection 0.039 0.04 0.16 0.59 -0.1 6E-16 0.1 0.2 0.3 0.4 0.5 0.6 vol
Slide 30: CARENET: 30-day DW-MRI analysis
CARENET : 30 - day DW - MRI analysis All but one peri - procedural ipsilateral lesions RESOLVED * * External Core Lab analysis (US) J. Schofer, P. Musialek et al. 2015 (manuscript at review) DW - MRI analysis @ 30 days* Incidence of new ipsilateral lesions 1 Average lesion volume (cm 3 ) 0.08 ± 0.00
Slide 31: CGuard: Long-term Stent Evaluation
C Guard : Long - term Stent Evaluation Routine Duplex Doppler ultrasound at discharge , 30 days , 6 and 12 months and then yearly J. Schofer, P. Musialek et al. 2015 (manuscript at review) ( Intravascular ultrasound ) . . (CT angiography ) . 2015
Slide 32: CARENET in-stent Peak Systolic Velocities
2015 NB. in one patient 6 mo ultrasound data pending CARENET in - stent P eak S ystolic V elocities > 50 % in - stent stenosis threshold * >7 0 % in - stent stenosis threshold * 30 day 6 months * Setacci et. al, Grading Carotid Intrastent Restenosis of 814 CAS patients Stroke . 2008 (NB. ECA patency
Slide 33: Excellent stent expansion and apposition, zero tissue protrusion
Excellent stent expansion and apposition ZERO tissue protrusion though mesh - and - struts Initial series of IVUS CG u ard TM studies suggests ... √ √ . . Piotr Musialek @ LINC 2015
Slide 34: CGuard months follow-up
2015 5 months follow - up CGuard Piotr Musialek @ LINC 2015
Slide 35: CGuard vs Wallstent and Precise follow-up
2015 RCCA & RICA LICA CGuard Piotr Musialek @ LINC 2015 5 months follow - up Wallstent Precise
Slide 36: CGuard: Endovascular solution for all-comers
C Guard : Endovascular Solution For All - comers 61 yo symptomatic LICA 72 yo asymptomatic RICA 2015 Piotr Musialek @ LINC 2015
Slide 37: Emboli generation 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 @ LINC 2015 2015
Slide 38: CAS: 2010 Vision
JOURNAL OF VASCULAR SURGERY terezie November 2010 iurenven tions CAS: 2010 Vision Kosmas I. Paraskevas, MD,* Dimitri P. Mikhailidis, MD, FEPM, FRCPath, FRCP," and 2015 Frank J. Veith, MD, FACS, Athens, Greece; London, United Kingdom; Cleveland, Ohio; and New York, NY Improved technology for CAS — be
Slide 39: CGuard embolic prevention stent system
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 . . . . . . √ √ √ √ √ √ 2015 Piotr Mu
Slide 40: 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 2015 Piotr Musialek @ LINC 2015
Slide 41: CARENET Conclusions
CARENET C onclusions • CARENET Trial demonstrated unprecedented safety of the CGuard stent , with 30 - day MACCE rate of 0%. • The CGuard device success and p rocedure success rate w ere 100%. • Majority of patients treated with CGuard have zero ipsilateral lesions on post - procedural DWI. 2015
Slide 42: CARENET Conclusions
CARENET C onclusions • 10 - fold reduction in average lesion volume when compared to conventional carotid stents . • All but one peri - procedural lesion had resolved completely by 30 days. • 6 month ultrasound analysis is indicative of normal stent healing without any restenosis concern and with no