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

Not Applicable

Completed

• Conditions: Coronary Stenosis; Coronary Atherosclerotic Disease; Coronary Artery Diseases; Myocardial Ischemia; Coronary Occlusive Diseases
• Interventions: Device: Driver Cobalt Alloy Coronary Stent; Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent

• Registration Number: NCT00920283
• Lead Sponsor: CID - Carbostent & Implantable Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Study Start: 2009-07
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Driver, Cobalt Alloy Coronary Stent	Driver Cobalt Alloy Coronary Stent	-
Chrono Carbostent Carbofilm™ Coated Coronary Stent	Chrono Carbostent Carbofilm™ Coated Coronary Stent	-

Primary Outcome Measures

Name	Time	Method
in-stent late lumen loss (LLL)	180 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Azienda Ospedaliera Universitaria; 🇮🇹 Roma, Italy

Ospedale Civile Maggiore- Borgo Trento; 🇮🇹 Verona, Italy

Azienda Ospedaliera Policlinico di Modena; 🇮🇹 Modena, Italy

Ospedale Civile S.Agostino-Estense-Baggiovara; 🇮🇹 Modena, Italy

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy

Cardinal Massaia Hospital; 🇮🇹 Asti, Italy