Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilmâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chrono Carbostent Carbofilmâ„¢ Coated Coronary Stent | Experimental |
| |
| Driver, Cobalt Alloy Coronary Stent | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chrono Carbostent Carbofilmâ„¢ Coated Coronary Stent | Device |
| ||
| Driver Cobalt Alloy Coronary Stent |
| Measure | Description | Time Frame |
|---|---|---|
| in-stent late lumen loss (LLL) | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic binary restenosis (diameter stenosis ≥50%) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Flavio Airoldi, Dr | Multimedica IRCCS, Sesto SG (MI) Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Cecilia Hospital | Cotignola | Ravenna | 48010 | Italy | ||
| Cardinal Massaia Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| 30 days, 180 days, 1 year |
| Stent Thrombosis | acute, 30 days, 180 days, 1 year |
| Acute success (Device and Procedural success) | acute |
| Asti |
| 14100 |
| Italy |
| Azienda Ospedaliera Policlinico di Modena | Modena | Italy |
| Ospedale Civile S.Agostino-Estense-Baggiovara | Modena | Italy |
| Azienda Ospedaliera Universitaria | Roma | Italy |
| Ospedale Civile Maggiore- Borgo Trento | Verona | Italy |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided