Clinical trial NCT00920283: COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent
Official title: Randomized Comparison Between Two Cobalt-Chromium Balloon Expandable Stents for the Treatment of De Novo Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Atherosclerotic Disease
Coronary Occlusive Diseases
Coronary Artery Diseases
Myocardial Ischemia
Coronary Stenosis
Keywords: Stents
Bare Metal Stents
PCI
Coronary Artery Disease
Coronary Artery Stenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Lead sponsor: CID - Carbostent & Implantable Devices
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: in-stent late lumen loss (LLL)
timeFrame: 180 days
Secondary outcomes:
measure: Angiographic binary restenosis (diameter stenosis ≥50%)
timeFrame: 180 days
measure: 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
timeFrame: 30 days, 180 days, 1 year
measure: Stent Thrombosis
timeFrame: acute, 30 days, 180 days, 1 year
measure: Acute success (Device and Procedural success)
timeFrame: acute
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Asti
country: Italy
facility: Cardinal Massaia Hospital
city: Modena
country: Italy
facility: Azienda Ospedaliera Policlinico di Modena
city: Modena
country: Italy
facility: Ospedale Civile S.Agostino-Estense-Baggiovara
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Verona
country: Italy
facility: Ospedale Civile Maggiore- Borgo Trento
Study officials:
affiliation: Multimedica IRCCS, Sesto SG (MI) Italy
name: Flavio Airoldi, Dr
role: PRINCIPAL_INVESTIGATOR
References: