Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
NCT ID: NCT00300157
Last Updated: 2011-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
155 participants
INTERVENTIONAL
2005-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Percutaneous coronary intervention with Taxus stent
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
French Cardiology Society
OTHER
Responsible Party
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Rangueil Hospital
Principal Investigators
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Didier Carrié, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Rangueil Hospital Toulouse France
Hélène ELTCHANINOFF, MD-PhD
Role: STUDY_CHAIR
Hôpital Charles Nicolle Rouen FRANCE
Thierry LEFEVRE, MD
Role: STUDY_CHAIR
Hôpital Jacques Cartier ICPS Massy FRANCE
Marc SILVESTRI, MD
Role: STUDY_CHAIR
Polyclinique du Parc Rambot Aix en Provence FRANCE
Locations
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Polyclinique du Parc Rambot
Aix-en-Provence, , France
Clinique Rhône Durance
Avignon, , France
Clinique Saint Augustin
Bordeaux, , France
Chu Brest
Brest, , France
CHU CAEN
Caen, , France
Hôpital Cardiologique
Lille, , France
Clinique du Tonkin
Lyon, , France
Unité Cardio-Vasculaire
Marseille, , France
CHU NORD
Marseille, , France
Institut Hospitalier Jacques Cartier-ICPS
Massy, , France
Hôpital Bon Secours
Metz, , France
Clinique du Millénaire
Montpellier, , France
Nouvelles Cliniques Nantaises
Nantes, , France
Hôpital privé Les Franciscaines
Nîmes, , France
CHU Caremeau
Nîmes, , France
Hôpital COCHIN
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Groupe Hospitalier La Pitié-Salpetrière
Paris, , France
CHU Pontchaillou
Rennes, , France
Clinique Saint Hilaire
Rouen, , France
Hôpital Charles Nicolle
Rouen, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Institut Arnaud Tzanck
Saint-Laurent-du-Var, , France
CHU Toulouse Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Clinique Saint Gatien
Tours, , France
Countries
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Other Identifiers
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2004-06
Identifier Type: -
Identifier Source: org_study_id
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