MAXIMUS 

Study Design    Principal Investigator: Dr. Ashok Seth    Objective: The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus    Eluting Stent in de novo native vessel obstructive coronary artery disease.    Study Design: This was a single centre, prospective study. 105 patients have been enrolled in the study. Patients have been   followed for twelve months post-procedure. All patients had a repeat angiography at 8 months.    Status: Ongoing    Endpoints: The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days.    The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up determined by off-line   Quantitative Coronary Angiography.     The following secondary efficacy endpoints will be assessed • Angiographic success • Procedure success • Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5 mm   distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean diameter. In-stent pre-, post and at 8-month follow-up. • Clinically justified Target Lesion Revascularization (TLR) at 12 months   The following secondary safety endpoints will be assessed: • MACE until 12 months • Device related SAEs until 12 months • Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12   months) Baseline Demographics (n=105) N (%)   Diabetes 38 (37%)     Hypertension 50 (48%)     Smoker 31 (30%)     Dyslipidemia 37 (35%)     Previous MI 35 (33%)     Post Procedure Results   Pre Post   RVD (mean ± SD) (mm) 2.46 ± 0.51 2.61 ± 0.44   MLD (mean ± SD) (mm) 0.91 ± 0.42 2.29 ± 0.40   % Diameter stenosis (mm) 62.73 ± 15.57 12.08 ± 5.89   Mean Lumen Diameter (mm) 2.16 ± 0.43 2.68 ± 0.4   Total occlusion 20/185 (10.81%) 0/185 (0%)   Stent-Absolute gain (mm) - 1.38 ± 0.49   Clinical Outcome: (N=105)   1 Month 8 Month   Asymptomatic 0 0   Symptomatic 1 2   MACE                 Death 0 1             MI 0 0             Re-Intervention 0 1*             TVR 0 0         * No Target Lesion Angioplasty 8 Month F-up: Matched Data In-Stent (N=71) Pre Post 8 Month F-up   RVD (mm) 2.50 ± 0.51 2.64 ± 0.46 2.36 ± 0.40   MLD (mm) 0.94 ± 0.43 2.32 ± 0.42 1.94 ± 0.37   %DS 62.1 ± 15.5 12.0 ± 6.30 17.7 ± 8.80   Mean Lumen Diameter (mm) 2.19 ± 0.43 2.71 ± 0.41 2.41 ± 0.34   %DS > 50 % - - 1 (0.8%)   Total Occlusion 13 (10.3%) 0 0   Absolute Gain (mm) - - 1.38 ± 0.50   Loss Index - - 0.28 ± 0.23   Absolute Loss (mm) - - 0.38 ± 0.29   8 Month F-up: Matched Data In-Segment (N=71) Post 8 Month F-up   RVD (mm)   2.57 ± 0.50 2.31 ± 0.42   MLD (mm)   2.07 ± 0.48 1.74 ± 0.39   %DS   19.3 ± 9.30 24.7 ± 8.50   Mean Lumen Diameter (mm)   2.67 ± 0.42 2.36 ± 0.36   %DS > 50 %   - 2 (1.6%)   Absolute Gain (mm)   - 1.14 ± 0.56   Loss Index   - 0.29 ± 0.34   Absolute Loss (mm)   - 0.33 ± 0.32