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Completed

NCT Number: NCT00920283

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

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.

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Key information

Conditions

Coronary Atherosclerotic Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Diseases Coronary Disease Coronary Occlusive Diseases Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Cecilia Hospital, Cotignola, Ravenna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chrono Carbostent Carbofilm™ Coated Coronary Stent

Device

Driver Cobalt Alloy Coronary Stent

Device

Primary outcomes

  1. in-stent late lumen loss (LLL)

    Time frame: 180 days

Secondary outcomes

  1. Angiographic binary restenosis (diameter stenosis ≥50%)

    Time frame: 180 days

  2. 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

    Time frame: 30 days, 180 days, 1 year

  3. Stent Thrombosis

    Time frame: acute, 30 days, 180 days, 1 year

  4. Acute success (Device and Procedural success)

    Time frame: acute

Sponsors and collaborators

Lead sponsor

CID - Carbostent & Implantable Devices

Industry

Registry information

Official study title

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

Acronym: COMPETE

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 15, 2009
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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