SIMPLE II

Study Design

Principal Investigator: Prof. D. S. Gambhir                          Study Design: This is a multicenter (8 sites), prospective study. 103 patients have been enrolled in the study. Patients have been   followed for nine months post-procedure. All patients had repeat angiography assessment at 6 months.    Objective: The main objective of this study is to assess the safety and effectiveness of the Infinnium® Paclitaxel eluting stent   in single de novo native coronary lesions.    No. of Centers: 8 (India, Brazil and The Netherlands)    Status: Completed *Published in EuroIntervention Volume 2 - Number 3 - November 2006 - ISSN: 1774-024X

BASELINE CHARACTERISTICS (n=103) (%)   Previous MI 38.8%   Previous CABG 1.9%   Previous PCI 5.8%   Diabetes mellitus 28.2%   Hypercholesterolaemia 52.4%   Hypertension 62.1%   Current smoker 32.0%   Reference diameter of the vessel (mm)  2.59 ± 0.44   LESION CLASSIFICATION (%)   Type B2 (%) 54.5%

Quantitative Coronary Angiographic (QCA) analysis (n=96) at 6 Month   In-stent In-segment Proximal edge Distal edge  Late loss (mm) 0.38 ± 0.49 0.18 ± 0.46 0.13 ± 0.52 0.02 ± 0.41 > 50% restenosis  (% of patients) 7.3 8.3 3.1 2.1 MACE AT 9 MONTH FOLLOW-UP (%)   Cardiac Death 1.0%   MI 3.9%                  - Q-Wave MI 1.0%                  - Non-Q-Wave MI 2.9%   CABG 1.0%   Re-PCI 1.0%   Late angiographic Stent Thrombosis 1.0%   MACE 6.8%