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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chrono Carbostent Carbofilm™ Coated Coronary Stent

Group Type EXPERIMENTAL

Chrono Carbostent Carbofilm™ Coated Coronary Stent

Intervention Type DEVICE

Driver, Cobalt Alloy Coronary Stent

Group Type ACTIVE_COMPARATOR

Driver Cobalt Alloy Coronary Stent

Intervention Type DEVICE

Interventions

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Chrono Carbostent Carbofilm™ Coated Coronary Stent

Intervention Type DEVICE

Driver Cobalt Alloy Coronary Stent

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No