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

Sponsor

CID - Carbostent & Implantable Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT00920283

Collaborator

(none)

205

Enrollment

Locations

Arms

Actual Duration (Months)

34.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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 Coronary Stent System. In this study, 204 subjects will be included (2:1 randomization Chrono:Driver/Micro Driver) in 6 Italian sites.

Condition or Disease	Intervention/Treatment	Phase
Coronary Atherosclerotic Disease Coronary Occlusive Diseases Coronary Artery Diseases Myocardial Ischemia Coronary Stenosis	Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent Device: Driver Cobalt Alloy Coronary Stent	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

205 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chrono Carbostent Carbofilm™ Coated Coronary Stent	Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent
Active Comparator: Driver, Cobalt Alloy Coronary Stent	Device: Driver Cobalt Alloy Coronary Stent

Arm

Intervention/Treatment

Experimental: Chrono Carbostent Carbofilm™ Coated Coronary Stent

Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent

Active Comparator: Driver, Cobalt Alloy Coronary Stent

Device: Driver Cobalt Alloy Coronary Stent

Outcome Measures

Primary Outcome Measures

in-stent late lumen loss (LLL) [180 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Azienda Ospedaliera Universitaria	Roma		Italy
6	Ospedale Civile Maggiore- Borgo Trento	Verona		Italy