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

Myocardial Ischemia Clinical Trial

— COMPETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920283
• Other study ID #: C10901
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: June 2013

Study information

• Verified date: May 2018
• Source: CID - Carbostent & Implantable Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Chrono Carbostent Carbofilm™ Coated Coronary Stent

• Driver Cobalt Alloy Coronary Stent

Locations

Country	Name	City	State
Italy	Cardinal Massaia Hospital	Asti
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	Azienda Ospedaliera Policlinico di Modena	Modena
Italy	Ospedale Civile S.Agostino-Estense-Baggiovara	Modena
Italy	Azienda Ospedaliera Universitaria	Roma
Italy	Ospedale Civile Maggiore- Borgo Trento	Verona

Sponsors (1)

Lead Sponsor	Collaborator
CID - Carbostent & Implantable Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-stent late lumen loss (LLL)		180 days
Secondary	Angiographic binary restenosis (diameter stenosis =50%)		180 days
Secondary	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
Secondary	Stent Thrombosis		acute, 30 days, 180 days, 1 year
Secondary	Acute success (Device and Procedural success)		acute