Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

NCT ID: NCT00300157

Last Updated: 2011-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Arteriosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous coronary intervention with Taxus stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rangueil Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Polyclinique du Parc Rambot

Aix-en-Provence, , France

Site Status

Clinique Rhône Durance

Avignon, , France

Site Status

Clinique Saint Augustin

Bordeaux, , France

Site Status

Chu Brest

Brest, , France

Site Status

CHU CAEN

Caen, , France

Site Status

Hôpital Cardiologique

Lille, , France

Site Status

Clinique du Tonkin

Lyon, , France

Site Status

Unité Cardio-Vasculaire

Marseille, , France

Site Status

CHU NORD

Marseille, , France

Site Status

Institut Hospitalier Jacques Cartier-ICPS

Massy, , France

Site Status

Hôpital Bon Secours

Metz, , France

Site Status

Clinique du Millénaire

Montpellier, , France

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

Site Status

Hôpital privé Les Franciscaines

Nîmes, , France

Site Status

CHU Caremeau

Nîmes, , France

Site Status

Hôpital COCHIN

Paris, , France

Site Status

Institut Mutualiste Montsouris

Paris, , France

Site Status

Groupe Hospitalier La Pitié-Salpetrière

Paris, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

Clinique Saint Hilaire

Rouen, , France

Site Status

Hôpital Charles Nicolle

Rouen, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Institut Arnaud Tzanck

Saint-Laurent-du-Var, , France

Site Status

CHU Toulouse Rangueil

Toulouse, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Clinique Saint Gatien

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TAXUS PERSEUS Small Vessel
NCT00489541 COMPLETED PHASE3
Trial for MicroPort's DCB
NCT04386213 UNKNOWN NA