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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions

Conditions
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Coronary Atherosclerotic Disease, Coronary Occlusive Diseases, Coronary Artery Diseases, Myocardial Ischemia, Coronary Stenosis

Intervention / Treatment
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* Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent
* Device: Driver Cobalt Alloy Coronary Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chrono Carbostent Carbofilm™ Coated Coronary Stent<br> | Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent<br> <br> |
| Active Comparator: Driver, Cobalt Alloy Coronary Stent<br> | Device: Driver Cobalt Alloy Coronary Stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent late lumen loss (LLL) |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 30 days, 180 days, 1 year | 
| Stent Thrombosis |  | acute, 30 days, 180 days, 1 year | 
| Acute success (Device and Procedural success) |  | acute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Bare Metal Stents, PCI, Coronary Artery Disease, Coronary Artery Stenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia