Myocardial Ischemia Clinical Trial
— COMPETEOfficial title:
Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
NCT number | NCT00920283 |
Other study ID # | C10901 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2009 |
Est. completion date | June 2013 |
Verified date | May 2018 |
Source | CID - Carbostent & Implantable Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 205 |
Est. completion date | June 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Cardinal Massaia Hospital | Asti | |
Italy | Maria Cecilia Hospital | Cotignola | Ravenna |
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 |
Lead Sponsor | Collaborator |
---|---|
CID - Carbostent & Implantable Devices |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | in-stent late lumen loss (LLL) | 180 days | ||
Secondary | Angiographic binary restenosis (diameter stenosis =50%) | 180 days | ||
Secondary | 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 | 30 days, 180 days, 1 year | ||
Secondary | Stent Thrombosis | acute, 30 days, 180 days, 1 year | ||
Secondary | Acute success (Device and Procedural success) | acute |
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