COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent

CID Carbostent & Implantable Devices

Status

Completed

Conditions

Coronary Artery Diseases

Myocardial Ischemia

Coronary Occlusive Diseases

Coronary Atherosclerotic Disease

Coronary Stenosis

Treatments

Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent

Device: Driver Cobalt Alloy Coronary Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00920283

C10901

Details and patient eligibility

About

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.

Enrollment

205 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.