COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent

Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions

The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1 randomization Chrono:Driver/Micro Driver) in 6 Italian sites.

Inclusion Criteria:

• Patients with clinical evidence of ischemic heart disease;
• No clinical and ECG changes suggestive of ongoing acute infarction;
• De novo lesion > 50% and <100% diameter stenosis (DS) in native coronary vessels TIMI flow of >= 1.
• Reference diameter > 2.5 mm or < 4.0 mm;
• Patients with a maximum of two coronary lesions to be treated with a maximum of 2 study stents;

Exclusion Criteria:

• Lesion length > 30 mm;
• Significant (>50%) stenosis proximal or distal to the target lesions that might impede run off;
• Lesions located in saphenous vein graft;
• Lesions located in unprotected left main;
• Presence of > 40% stenosis in the left main;
• Ostial lesion;
• Lesion located in a bifurcation;
• Target lesion with visible thrombus;
• Chronic total occlusion;
• Treatment of restenotic lesions;
• Previous implantation of a stent (BMS/DES) in the target vessel.