1. The Cardiomind Sparrow DES Program (CARE II)
CRT 2010
Washington, DC
The Cardiomind Sparrow DES Program
(CARE II)
Alexandre Abizaid, MD, PhD, FACC
Instituto Dante Pazzanese de Cardiologia
Sao Paulo - Brazil
Columbia University
New York - USA

2. Alexandre Abizaid, MD, PhD
Consulting Fees
Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson company

3. Treatment of Small Vessels Requires Specific Design Features
Enhanced Flexibility & Deliverability
Low profile delivery system
Reduced barotrauma (low pressure, minimized extension stent margins)
Self-expanding stent
Minimal tissue reaction
 Biodegradable polymer matrix
Specific efficacy in small vessels, diabetics
 Sirolimus or Limus type drug

4. 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

5. CardioMind® Sparrow® Stent Delivery System Detail
Wire Tip

6. 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 MicroFusion
Coating
Drug Coating
4 μm Sirolimus Coating
SynBiosys Biodegradable
Block Copolymer
~6 μg drug /mm Length
Investigational Device, Not for Sale in the US 6

7. CardioMind Sparrow Delivery System Highlights for CARE II
Non-Sterile,
reusable, hand-held
Power Supply
Sterile,
Disposable
Adapter
Delivery
System
Stent
Lead Connection/
Wire Extension

8. Delivery of the Sparrow® Coronary Stent
Investigational Device, For Export Only

9. The CardioMind® DES Sparrow® Stent:
Sirolimus in the Biodegradable SynBiosys Matrix

10. Sparrow® Sirolimus-eluting Stent Characteristics (SynBiosys PLA biodegradable copolymer matrix)

11. 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

12. CARE II STUDY DESIGN Sparrow DES= 80 Sparrow BM = 80
2 Arm Sub-Set
1:1 randomization
Sparrow DES: Sparrow BM
4 Centers
CARE II RCT
4:4:3 (80:80:60)
Total N=220 + roll in
3 Arm Sub-Set
1:1:1 randomization
Sparrow DES: Sparrow BM:
Micro-Driver/Driver BM
14 Centers
IVUS sub-study (n = 7 centers)
Sparrow - BM
(N=60)
Micro-Driver/
Driver
Sparrow – DES
(~6ug/mm Sirolimus)
Sparrow - BM
(N=20)
Sparrow – DES
(~6 ug/mm Sirolimus)
Sparrow DES= 80
Sparrow BM = 80
Micro-Driver/Driver = 60
For Superiority Study of
Sparrow DES: Sparrow BM
Pool common arms together 12 12

13. 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 13

14. 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

15. CARE II STUDY DESIGN Study Assumptions Adaptive Study Design
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

16. CARE II PRIMARY ENDPOINT
In-stent Late Lumen Loss at 8 months by QCA
Primary Analysis
Sparrow DES superiority over Sparrow BMS
Hierarchal Analyses
Sparrow DES superiority over Commercial BMS
Sparrow BMS non-inferiority to Commercial BMS
Sparrow BMS superiority over Commercial BMS

17. CARE II Enrollment Status
102 RCT and 138 patients total in CARE II
108 Patients in CardioMind Arm (DES or BMS)
Vessels Treated with Sparrow Device
LAD %
LCX – 42.6 %
RCA – 19.4%
Front Line Use (access/pre and post dil)
72% (78/108) cases w/ Monorail/OTW

18. 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%

19. 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%

20. 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).

21. CARE II – Device Cross-Overs for CardioMind CARE II
Device Success of 92.4% (73/79)
Study Definition: Attainment of <30% residual stenosis of the target lesion
using the CardioMind device (“in-stent” % diameter stenosis).
Reason for Cross-Over
Patients
Pre- or post- dil dissection
(unrelated to stent implantation) 3
Training/Lesion (Ca++) resulting in stent release issues 2
Electrical Fault 1
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).

22. CARE II 8 –month Follow-up
Pre Post month FU
Device Success: attainment of <30% residual stenosis of the target lesion using the CardioMind device (“in-stent” % diameter stenosis). (5 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).

24. 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

25. KEY INCLUSION CRITERIA
Single, native de novo target lesion with option to treat one other non-target lesion in a different epicardial vessel
Reference vessel diameter 2.0 – 2.75 mm
Lesion length < 20 mm
Stenosis > 50% and < 100%
Lesion is amenable to pre-treatment with balloon angioplasty only
Subject agrees to return for 8 month angiographic follow-up

26. 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 26 26