COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent (COMPETE)
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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.
in-stent late lumen loss (LLL) [ Time Frame: 180 days ]
Secondary Outcome Measures :
Angiographic binary restenosis (diameter stenosis ≥50%) [ Time Frame: 180 days ]
Clinical Composite Endpoints: - Cardiac death/ MI - Cardiac death / Target vessel MI / (Clinically indicated) TLR* - All death / MI / all repeat revascularization** *Device oriented composite endpoint **Patient oriented composite endpoint [ Time Frame: 30 days, 180 days, 1 year ]
Stent Thrombosis [ Time Frame: acute, 30 days, 180 days, 1 year ]
Acute success (Device and Procedural success) [ Time Frame: acute ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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;
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;
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.