Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent - Full Text View

Sponsors and Collaborators:	French Cardiology Society Boston Scientific Corporation
Information provided by:	French Cardiology Society
ClinicalTrials.gov Identifier:	NCT00300157

Purpose

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.

Condition	Intervention	Phase
Coronary Arteriosclerosis	Device: Percutaneous coronary intervention with Taxus stent	Phase III

MedlinePlus related topics: Angioplasty Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:

Coronarography [ Time Frame: 9 months ]

Secondary Outcome Measures:

Major cardio-vascular events [ Time Frame: 1, 18 and 36 months ]

Estimated Enrollment:	150
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2009

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300157

Contacts

Contact: Didier Carrié, MD-PhD	33.561323311	carrie.d@chu-toulouse.fr
Contact: Hélène Eltchaninoff, MD-PhD	33.332888232	helene.eltchaninoff@chu-rouen.fr

Locations

France
CHU Toulouse Rangueil	Recruiting
Toulouse, France, 31059
Contact: Didier CARRIE, MD-PhD 33.561323311 carrie.d@chu-toulouse.fr
Hôpital Charles Nicolle	Not yet recruiting
Rouen, France, 76031
Contact: Hélène ELTCHANINOFF, MD-PhD 33.332888232 helene.eltchaninoff@chu-rouen.fr
Institut Hospitalier Jacques Cartier-ICPS	Recruiting
Massy, France, 91300
Contact: Thierry LEFEVRE, MD 33.160134602 t.lefevre@icps.com.fr
Polyclinique du Parc Rambot	Recruiting
Aix-en-Provence, France, 13100
Contact: Marc Silvestri, MD 33.442331727 dr_msilvestri@hotmail.fr
Unité Cardio-Vasculaire	Not yet recruiting
MARSEILLE, France, 13009
Contact: Pierre LABRUNIE, MD 33.491740506 plabrunie@ucvnet.com
Centre Cardiologique du Nord	Not yet recruiting
Saint-Denis, France, 93200
Contact: Philippe GUYON, MD 33.149334113 philippeguyon@numericable.fr
Clinique Saint Hilaire	Not yet recruiting
Rouen, France, 76000
Contact: René Koning, MD 33.235086621 rkoning@clinique-sainthilaire.fr
CHU Pontchaillou	Recruiting
RENNES, France, 35033
Contact: Hervé LE BRETON, MD-PhD 33.299282505 herve.le.breton@chu-rennes.fr
CHU CAEN	Not yet recruiting
CAEN Cedex, France, 14033
Contact: Martial HAMON, MD-PhD 33.231064412 hamon-m@chu-caen.fr
Clinique du Millénaire	Recruiting
Montpellier, France, 34960
Contact: Gilles LEVY, MD 33.467141000 glevy@club-internet.fr
Hôpital Bon Secours	Recruiting
METZ, France, 57000
Contact: khalife KHALIFE, MD 33.387553231 K1khalife@aol.com
Hôpital Cardiologique	Not yet recruiting
LILLE, France, 59037
Contact: Jean Marc LABLANCHE, MD-PhD 33.320445302 jmlablanche@chru-lille.fr
Clinique Saint Augustin	Not yet recruiting
BORDEAUX, France, 33000
Contact: Olivier DARREMONT, MD 33.320445302 o.darremont@free.fr
Groupe Hospitalier La Pitié-Salpetrière	Not yet recruiting
PARIS, France, 75651
Contact: Jean Philippe METZGER, MD 33.142162911 jean-philippe.metzger@psl.ap-hop-paris.fr
Clinique du Tonkin	Not yet recruiting
LYON, France, 69100
Contact: Ricardo RORIZ, MD 33.472826729 ricardo.roriz@clinique-tonkin.fr
Clinique Pasteur	Not yet recruiting
TOULOUSE, France, 31100
Contact: Jean FAJADET, MD 33.562211699 fajadet@interv-cardio-toul.com
CHU BREST	Recruiting
BREST, France, 29609
Contact: Martine GILARD, MD-PhD 33.298347505 martine.gilard@chu-brest.fr
Hôpital COCHIN	Recruiting
PARIS, France, 75014
Contact: Christian SPAULDING, MD-PhD 33.158411657 christian.spaulding@cch.ap-hop-paris.fr
CHU NORD	Not yet recruiting
MARSEILLE, France, 13326
Contact: Franck PAGANELLI, MD 33.491968683 franck.paganelli@mail.ap-hm.fr
CHU Caremeau	Recruiting
NIMES, France, 30029
Contact: Laurent SCHMUTZ, MD 33.466683116 laurent.schmutz@chu-nimes.fr
Institut Mutualiste Montsouris	Not yet recruiting
PARIS, France, 75014
Contact: Alain DIBIE, MD 33.156616510 alain.dibie@imm.fr
Clinique Rhône Durance	Not yet recruiting
AVIGNON, France, 84082
Contact: Joël SAINSOUS, MD 33.490148190 scp.cardio.rd@wanadoo.fr
Institut Arnaud Tzanck	Not yet recruiting
Saint Laurent du Var, France, 06700
Contact: Pierre MEYER, MD 33.492273867 pmeyer@tzanck.org
Hôpital privé Les Franciscaines	Not yet recruiting
NIMES, France, 30000
Contact: Eric MAUPAS, MD 33.466266375 eric.maupas@wanadoo.fr
Clinique Saint Gatien	Not yet recruiting
TOURS, France, 37042
Contact: Didier BLANCHARD, MD 33.247605101 didier.blanchard@wanadoo.fr
Nouvelles Cliniques Nantaises	Not yet recruiting
NANTES, France, 44000
Contact: Philippe BRUNEL, MD 33.251862503 brunel-philippe@wanadoo.fr

Sponsors and Collaborators

French Cardiology Society

Boston Scientific Corporation

Investigators

Principal Investigator:	Didier Carrié, MD-PhD	Rangueil Hospital Toulouse France
Study Chair:	Hélène ELTCHANINOFF, MD-PhD	Hôpital Charles Nicolle Rouen FRANCE
Study Chair:	Thierry LEFEVRE, MD	Hôpital Jacques Cartier ICPS Massy FRANCE
Study Chair:	Marc SILVESTRI, MD	Polyclinique du Parc Rambot Aix en Provence FRANCE

More Information

Study ID Numbers:	2004-06
Study First Received:	March 7, 2006
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00300157
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French Cardiology Society:

Left main coronary artery stenosis, stent, Taxus
Unprotected left main coronary artery disease
Percutaneous coronary intervention with Taxus stent

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Constriction, Pathologic
Ischemia
Arteriosclerosis
Coronary Stenosis
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009