Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not

Conditions
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Coronary Arteriosclerosis

Intervention / Treatment
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* Device: Percutaneous coronary intervention with Taxus stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous coronary intervention with Taxus stent|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronarography |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardio-vascular events |  | 1, 18 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left main coronary artery stenosis, stent, Taxus, Unprotected left main coronary artery disease, Percutaneous coronary intervention with Taxus stent