Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

French Cardiology Society

Status and phase

Completed

Phase 3

Conditions

Coronary Arteriosclerosis

Treatments

Device: Percutaneous coronary intervention with Taxus stent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00300157

2004-06

Details and patient eligibility

About

The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

Full description

Coronary artery bypass graft is the reference treatment of left main coronary artery disease. With the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. In these particular situations,some centers performed percutaneous coronary angioplasty (PCI) with drug-eluting stents with acceptable results in terms of safety and efficacy. However, these procedures are performed at isolated sites and are not evaluated in multicenter trial.The aim of this study is to assess the safety and efficacy of this PCI with Taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up.

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must be > or = 18 years of age
Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee
Aspirin + Clopidogrel > or = 12 hours before percutaneous coronary intervention (PCI)
Documented evidence of ischemic heart disease (clinical,biological or ECG) with unprotected left main coronary artery stenosis > or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours
The target reference vessel diameter must be > or = 2.5 mm
Unprotected left main coronary artery disease eligible by coronary stenting

Exclusion criteria

Restenosis lesion in left main coronary artery
Known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel
Acute coronary syndrome < 48 hours
Impaired renal function (creatinine > 180 ùmol/l) at the time of treatment
Life expectancy less than 36 months
Female of childbearing potential without reliable birth control
Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints