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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00920283

Acronym

COMPETE

Enrollment

205

Registered

2009-06-15

Start date

2009-07-31

Completion date

2013-06-30

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Stents, Bare Metal Stents, PCI, Coronary Artery Disease, Coronary Artery Stenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia

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.

Interventions

DEVICEChrono Carbostent Carbofilm™ Coated Coronary Stent

DEVICEDriver Cobalt Alloy Coronary Stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
in-stent late lumen loss (LLL)	180 days

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026