Status:
COMPLETED
COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent
Lead Sponsor:
CID - Carbostent & Implantable Devices
Conditions:
Coronary Atherosclerotic Disease
Coronary Occlusive Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Coron...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00920283
Start Date
July 1 2009
End Date
June 1 2013
Last Update
May 7 2018
Active Locations (6)
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1
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48010
2
Cardinal Massaia Hospital
Asti, Italy, 14100
3
Azienda Ospedaliera Policlinico di Modena
Modena, Italy
4
Ospedale Civile S.Agostino-Estense-Baggiovara
Modena, Italy