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Harvard Medical School Brigham and Women’s Hospital
CARDIOMIND® stent-on-a-wire self-expanding microstent: Results from CARE I (2-yr follow-up) and CARE II Update (Sirolimus-eluting Microstent) Laura Mauri MD, MSc. Harvard Medical School Brigham and Women’s Hospital
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Laura Mauri, MD DISCLOSURES
Laura Mauri has consulted for Cordis Corporation and Medtronic Vascular Research support to Harvard Clinical Research Institute from: Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb/Sanofi-Aventis Pharmaceuticals Partnership, Eli Lilly and Company and Daiichi Sankyo Company Limited
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CardioMind® Sparrow® Stent Delivery System: “Stent-in-a-Wire”
CardioMind® Sparrow® Stent Delivery System: “Stent-in-a-Wire” .014” Guidewire Design 2 mm Sparrow Balloon Exp Stent Investigational Device, Not for Sale in the US
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CardioMind® Sparrow® Stent Delivery System
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The CardioMind® Sparrow® Stent Delivery System
.014” Guide Wire Platform 2 cm Pt Coil Tip Battery Powered Electrical Release 9 VDC & 15 VPP (100kHz AC) 0.2 milliAmp Stent Nitinol Closed Cell Ultra Thin Strut (.0024”) mm Stent OD 17-24mm Stent Lengths 3.5μm Platinum Blend Coating Drug Coating 4 μm Sirolimus Coating SynBiosys Biodegradable Block Copolymer ~6 μg drug /mm Length Investigational Device, Export Only 5
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The CardioMind® DES Sparrow® Stent:
Sirolimus in the Biodegradable SynBiosys Matrix
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Sparrow® Sirolimus-eluting Stent Characteristics (SynBiosys PLA biodegradable copolymer matrix)
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Pathology Results in Porcine Model: Sparrow DES stented vessels recovers to bare metal type of tissue response at 180 days 28 Day 90 Day 180 Day Bare Metal Sparrow DES Sparrow Sirolimus in SynBiosys PLA/PLGA copolymers
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CARE I CARE I - Bare Metal Sparrow Stent (n=22, St Vincent’s Melbourne and Dante Pazzanese) Single De Novo Native Coronary Artery Lesions Vessel Diameters: 2.0 – 2.6 mm Stent Diameters: 2.5 – 3.0 mm Lesion Length: ≤14 mm Primary Stent Length: 18 mm 12 mm Length for Bailout Only Pre-Dilatation and Post-Dilatation Required Clinical Follow-Up 30d 6mo 9mo 12 mo 2yr 3yr Angiographic / IVUS ( 22 pts) Follow-Up Primary Endpoint: MACE at 30 days (death, MI and TVR) Key Secondary Endpoints: Sub acute thrombosis (SAT) Device, Lesion and Procedure Success MACE at hospital discharge, 6, 9 & 12 mos Clinically driven TLR and TVF at 6, 9 & 12 mos ABR, LL and % volume obstruction at 6 & 12 mos Anti-Platelet Therapy for 3 months 9
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CARE I – Baseline Demographics (n=22 enrolled)
Characteristic Aggregate Age, Years 61.94±10.90 ( ) Male 63.6% (14/22) Prior MI 45.5% (10/22) Prior PCI 27.3% (6/22) History of Diabetes 50.0% (11/22) History of Hypertension 72.7% (16/22) Hyperlipidemia 86.4% (19/22) Current Smoker 36.4% (8/22) Family history of CAD 54.5% (12/22) History of Angina-Stable 68.2% (15/22) History of Angina-Unstable 9.1% (2/22) LVF (Normal)
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CARE I Results – Lesion Characteristics (n= 22 target lesions)
Aggregate (n=22) Target Vessel RCA 36.4% (8/22) LAD 13.6% (3/22) LCX 50.0% (11/22) Mean RVD (mm) 2.20±0.20 ( ) Mean Lesion Length (mm) 10.86±3.19 ( )
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CARE I – Baseline QCA (22 enrolled, 21 treated, 20 w/6 Mo. F/U)
Characteristic Aggregate Patients with 1 Vessel Disease 81.8% (18/22) Patients with 2 Vessel Disease 18.2% (4/22) Device Success 96% (24/25) Procedural Success 95% (21/22) Pre-Procedure % Diameter Stenosis (n=20 lesions) 71.31±13.17 ( ) Post-Procedure % Diameter Stenosis (n=20 lesions) 15.78±7.07 ( ) MLD Pre-Procedure (mm) 0.62±0.27 ( ) MLD Post-Procedure (mm) 1.91±0.27 ( )
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Serial Volume Index Changes at 6 Mo
CARE I Serial Volume Index Changes at 6 Mo (in-stent segment) Stent Volume Index Vessel Volume Index Plaque Volume Index* (mm3/mm) (mm3/mm) (mm3/mm) 8.41.7 8.41.7 +13% 4.50.9 4.41.0 4.00.9 3.90.9 p=NS P=0.0010 p=0.026 Baseline Follow-up Baseline Follow-up Baseline Follow-up Serial 3D IVUS analysis: n=13 Stanford * Peri-stent PVI
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IVUS Serial Volume Index
CARE I IVUS Serial Volume Index No Changes 6M v 12M (Reference segment) Proximal reference Distal reference (mm3/mm) (mm3/mm) 8.90.9 8.81.6 Vessel Volume Index 6.01.0 5.70.7 4.70.8 5.01.8 Plaque Volume Index 2.31.3 2.00.8 4.20.8 3.81.0 Lumen Volume Index 3.71.0 3.71.1 6 Mo 12 Mo 6 Mo 12 Mo Serial 3D IVUS analysis: n=6 Stanford
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CARE I - 6 & 12 Month QCA Results
Characteristic 6 Months Aggregate (n=19) 12 Months Aggregate (n=10) RVD (mm) (19) In-stent % DS ( ) ( ) In-segment % DS ( ) ( ) In-stent MLD (mm) ( ) ( ) In-segment MLD (mm) ( ) ( ) In-stent LLL (mm) ( ) ( ) In-segment LLL (mm) ( ) ( ) Binary Restenosis 21.1% (4/19) 20% (2/10)
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CARE I ( Bare Metal Stent) Clinical Follow-up Results to 12 months
30 Days 6 Months 12 Months MACE 2/21 (9.5%) Death 1/21 (4.7%) MI 0/21 TLR Stent Thrombosis Possible Probable Definite
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CARE I Final Results - 24 Months
CEC-Adjudicated Safety Endpoints Results (n = 21 pts) In-hospital MACE 0/21 (0%) 30 Days 6 Months 1/21 (4.8%) 8 Months 2/21 (9.5%) 12 Months 24 Months Major Vascular Events Stent 30 Days 17
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CARE I CARE I – Conclusions CARE I Bare Metal Nitinol stent evaluated in a complex patient set 50% Diabetic Average RVD 2.20 mm Safety Demonstrated in Feasibility Study Low MACE rates through 24 months Angiographic binary restenosis at 12 months = 20% 13% Stent expansion seen in IVUS at 6 months May offset any increases in NIV Serial IVUS shows stent expansion unchanged from 6 to 12 mo Sparrow Nitinol stent successfully delivered on a guidewire platform DES platform in evaluation in CARE II
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CARE II Randomized Clinical Study- 220 RCT Patient Planned Enrollment
Single De Novo Native Coronary Artery Lesions 2 Vessel (Target and Non-Target Vessel) Treatment allowed Vessel Diameters: 2.0 – 2.75 mm Lesion Length: ≤20 mm Primary Stent Lengths: 17 & 23/24 mm Pre-Dilatation and Post-Dilatation Required 30d 6mo mo 1yr 2yr 3yr 4yr 5yr Clinical / Telephone Follow-Up Angiographic / IVUS 8 mo Primary Endpoint: In Stent Late lumen 8 mo Key Secondary Endpoints: MACE at hospital discharge, 30 D, 8, 12 & 24 mo Sub acute thrombosis (SAT) Device, Lesion and Procedure Success Clinically driven TLR, TVR, TVF at 8, 12 & 24 mo QCA & IVUS (subset) endpoints at 8 mo Anti-Platelet Therapy for 8 months 19 19
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CARE II Investigational Sites
Region * = enrolling Principal Investigator Institution Brazil Sao Paulo* Uberlandia* Alexandre Abizaid, MD, PhD, CARE II PI Roberto Botelho, MD, PhD Instituto Dante Pazzanese Instituto Do Coracao Do Triangulo Mineiro Australia / New Zealand Melbourne* Adelaide* Brisbane* Sydney Auckland, NZ Christchurch, NZ Robert Whitbourn, MD, CARE II Regional PI Ian Meredith, MD Stephen Worthley, MD Darren Walters, MD Craig Juergens, MD John Ormiston, MD Dougal McClean, MD St. Vincent's Hospital Monash Medical Center Royal Adelaide Hospital Prince Charles Hospital Liverpool Hospital, NSW Auckland City Hospital Christchurch School of Med. Southeast Asia Singapore* Singapore Malaysia* Koh Tian Hai, MD Huay Cheem Tan, MD Robaayah Zambahari, MD National Heart Centre National University Hospital Institut Jantung Negara Europe Belgium* Belgium Germany* Switzerland* Spain* The Netherlands Stefan Verheye, MD, PhD William Wijns, MD Bernhard Witzenbichler, MD Stephan Windecker, MD Carlos Macaya, MD Pieter Stella MD, Pierfrancesco Agostoni MD AZ Middelheim, Antwerpen OLV Hospital, Aalst Charite-Benjamin Franklin, Berlin Swiss Cardiovasc. Ctr., Bern Hospital Clinico San Carlos Servicio de Hemodinamica University Hospital Centre, Utrecht 20
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CARE II Participating Institutions
Study Management Institution Data Management Clinical Events Committee Data Safety Monitoring Board CRF Core Labs Angiography IVUS EKG Stanford CRO Monitoring Australia/Asia Pacific Brazil Europe PCRG CRC MedPass 21
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CARE II Study Design Study Assumptions 4:4:3 Randomization
80 Sparrow DES: 80 Sparrow BMS: 60 MicroDriver/Driver BMS LLL Standard Deviations (SD) expected to differ between DES and BMS Adaptive Study Design First 100 randomized patients to be analyzed after 8 month follow-up able to increase sample size up to 25% if actual SD exceeds planned SD
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CARE II Enrollment Status
138 patients total in CARE II 108 Patients in CardioMind Arm (DES or BMS) Front Line Use (access/pre and post dil) 72% (78/108) cases w/ Monorail/OTW
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CARE II – Baseline Demographics (n=100 patients)
Characteristics CARE II (n=100) Mean Age 63 yr Male 66% History of Hypertension 83% History of Hyperlipidemia 88% History of Smoking 67% History of Diabetes 33% History of MI 37%
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CARE II – Pre- and Post- Procedure QCA
Characteristics CARE II (n=100) Target Vessel LAD 42 Left Circumflex 35 RCA 23 Pre-Procedural QCA Average Lesion Length (mm) 14.47 Reference Vessel Diameter (RVD, mm) 2.32 Percent Diameter Stenosis (% DS) 71% Post- Procedural QCA % Diameter Stenosis, In-lesion (Stent + 5mm Edge) 18.27% % Diameter Stenosis, In-stent 10.34% Acute Gain (mm) 1.45 Final TIMI Flow 3 100%
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CARE II – Acute Performance Results for CARE II CardioMind Patients
Characteristics CardioMind Implantations (n=79) Device Success 92.4% (73/79) Lesion Success 100% (79/79) Procedural Success 94.9% (75/79) Device Success: attainment of <30% residual stenosis of the target lesion using the CardioMind device (“in-stent” % diameter stenosis). (6 cross-overs) Lesion Success: attainment of < 30% residual stenosis using any percutaneous method. Procedure Success: Lesion Success without the occurrence of in-hospital MACE (total of 4 in-hospital NQMIs). 26
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CARE II DES Implantation
60 yr Female with diffuse disease in LAD (2.4mm RVD) 2.75mm X 24mm DES Stent Pre Post month FU Courtesy of Roberto Botelho M.D. PhD Instituto do Coração do Triângulo; Uberlândia-MG / Brazil
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CONCLUSIONS CardioMind Sparrow Stent System successfully used > 70% as front line wire Used with RX/monorail and over-the-wire catheters Femoral and Radial access CARE II randomized clinical trial with Sirolimus-eluting and Bare Metal Sparrow Stent in progress 138 patients enrolled at 13 centers Planned interim analysis at 8 Mo Follow-up of 102 RCT patients - April 2010 Intracranial clinicals to be initiated in 2010 Atherosclerotic disease, aneurysm, acute stroke indications
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