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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
205
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Cardinal Massaia Hospital
Asti, Italy
Azienda Ospedaliera Policlinico di Modena
Modena, Italy
Ospedale Civile S.Agostino-Estense-Baggiovara
Modena, Italy
in-stent late lumen loss (LLL)
Time frame: 180 days
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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Azienda Ospedaliera Universitaria
Roma, Italy
Ospedale Civile Maggiore- Borgo Trento
Verona, Italy