MAXIMUS 

Study Design    Principal Investigator: Dr. Ashok Seth    Objective: The primary objective of this study was 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 had been enrolled in the study. Patients had been   followed for twelve months post-procedure and repeat angiography at 8 months.    Status: Complete    Endpoints: The primary safety endpoint of the study was defined as Major Adverse Cardiac Events (MACE) at 30 days.   The primary efficacy endpoint was the in-stent binary restenosis rate at 8-month follow-up determined by off-line   Quantitative Coronary Angiography.     The following secondary efficacy endpoints had been 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 had been 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) Patient Risk Factors :  (%)     Diabetes Mellitus 37%       Hypertension 48%       Smoker 30%       Dyslipidemia 35%       Previous MI 33%       Lesion Morphology :  (%)     Type A 3%       Type B1 40%       Type B2 50%       Type C 7%       8 months QCA analysis     Pre Post Fup RVD (mm) In-Stent 2.48 ± 0.5 2.63 ± 0.46 2.37 ± 0.40   In-Segment   2.55 ± 0.49 2.33 ± 0.43 MLD (mm) In-Stent 0.89 ± 0.44 2.3 ± 0.42 1.91 ± 0.43   In-Segment   2.05 ± 0.47 1.72 ± 0.44 Late loss,mm In-Stent     0.39 ± 0.33    In-Segment     0.33 ± 0.35 Diameter Stenosis % In-Stent 63.77 ± 16.63 12.32 ± 6.38 19.20 ± 12.86   In-Segment   20.02 ± 8.68 25.98 ± 12.02 Binary Angiographic Restenosis, N(%) In-Stent     5 (3.3%)   In-Segment     7 (4.6%) Clinical follow up   1 Month 8 Month 12 Month Total   TVR 1 - 1 2 (2%)   TLR - 1 - 1 (1%)   CABG - - - 0   Stent Thrombosis 1 1 - 2 (2%)   Cardiac Death - 1 - 1 (1%)   Non cardiac death - 3 - 3 (3%)