Clinical trial NCT00300157: Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
Official title: French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Arteriosclerosis
Keywords: Left main coronary artery stenosis, stent, Taxus
Unprotected left main coronary artery disease
Percutaneous coronary intervention with Taxus stent
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2006-03-08
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Coronarography
timeFrame: 9 months
Secondary outcomes:
measure: Major cardio-vascular events
timeFrame: 1, 18 and 36 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Polyclinique du Parc Rambot
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Brest
country: France
facility: Chu Brest
city: CAEN Cedex
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Hôpital Cardiologique
city: Lyon
country: France
facility: Clinique du Tonkin
city: Marseille
country: France
facility: Unité Cardio-Vasculaire
city: Marseille
country: France
facility: CHU NORD
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier-ICPS
city: Metz
country: France
facility: Hôpital Bon Secours
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nimes
country: France
facility: Hôpital privé Les Franciscaines
city: Nimes
country: France
facility: CHU Caremeau
city: Paris
country: France
facility: Hôpital COCHIN
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Groupe Hospitalier La Pitié-Salpetrière
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Laurent du Var
country: France
facility: Institut Arnaud Tzanck
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: Clinique Saint Gatien
Study officials:
affiliation: Rangueil Hospital Toulouse France
name: Didier Carrié, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Charles Nicolle Rouen FRANCE
name: Hélène ELTCHANINOFF, MD-PhD
role: STUDY_CHAIR
affiliation: Hôpital Jacques Cartier ICPS Massy FRANCE
name: Thierry LEFEVRE, MD
role: STUDY_CHAIR
affiliation: Polyclinique du Parc Rambot Aix en Provence FRANCE
name: Marc SILVESTRI, MD
role: STUDY_CHAIR
References: