Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

Phase 3

Completed

• Conditions: Coronary Arteriosclerosis

• Registration Number: NCT00300157
• Lead Sponsor: French Cardiology Society

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-03
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Coronarography	9 months

Secondary Outcome Measures

Name	Time	Method
Major cardio-vascular events	1, 18 and 36 months

Trial Locations

Locations (26)

Clinique Saint Augustin; 🇫🇷 Bordeaux, France

CHU CAEN; 🇫🇷 CAEN Cedex, France

Hôpital COCHIN; 🇫🇷 Paris, France

Polyclinique du Parc Rambot; 🇫🇷 Aix-en-Provence, France

Unité Cardio-Vasculaire; 🇫🇷 Marseille, France

Chu Brest; 🇫🇷 Brest, France

Hôpital Bon Secours; 🇫🇷 Metz, France

Clinique Rhône Durance; 🇫🇷 Avignon, France

Hôpital Cardiologique; 🇫🇷 Lille, France

Clinique du Tonkin; 🇫🇷 Lyon, France

Institut Hospitalier Jacques Cartier-ICPS; 🇫🇷 Massy, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

CHU NORD; 🇫🇷 Marseille, France

Hôpital privé Les Franciscaines; 🇫🇷 Nimes, France

Clinique du Millénaire; 🇫🇷 Montpellier, France

CHU Caremeau; 🇫🇷 Nimes, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

Groupe Hospitalier La Pitié-Salpetrière; 🇫🇷 Paris, France

CHU Pontchaillou; 🇫🇷 Rennes, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Institut Arnaud Tzanck; 🇫🇷 Saint Laurent du Var, France

CHU Toulouse Rangueil; 🇫🇷 Toulouse, France

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Clinique Saint Gatien; 🇫🇷 Tours, France