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Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00300157
First received: March 7, 2006
Last updated: January 3, 2011
Last verified: January 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 155
Study Start Date: December 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Polyclinique du Parc Rambot
Aix-en-Provence, France, 13100
Clinique Rhône Durance
Avignon, France, 84082
Clinique Saint Augustin
Bordeaux, France, 33000
Chu Brest
Brest, France, 29609
CHU CAEN
CAEN Cedex, France, 14033
Hôpital Cardiologique
Lille, France, 59037
Clinique du Tonkin
Lyon, France, 69100
CHU NORD
Marseille, France, 13326
Unité Cardio-Vasculaire
Marseille, France, 13009
Institut Hospitalier Jacques Cartier-ICPS
Massy, France, 91300
Hôpital Bon Secours
Metz, France, 57000
Clinique du Millénaire
Montpellier, France, 34960
Nouvelles Cliniques Nantaises
Nantes, France, 44000
Hôpital privé Les Franciscaines
Nimes, France, 30000
CHU Caremeau
Nimes, France, 30029
Groupe Hospitalier La Pitié-Salpetrière
Paris, France, 75651
Hôpital COCHIN
Paris, France, 75014
Institut Mutualiste Montsouris
Paris, France, 75014
CHU Pontchaillou
Rennes, France, 35033
Hôpital Charles Nicolle
Rouen, France, 76031
Clinique Saint Hilaire
Rouen, France, 76000
Institut Arnaud Tzanck
Saint Laurent du Var, France, 06700
Centre Cardiologique du Nord
Saint-Denis, France, 93200
CHU Toulouse Rangueil
Toulouse, France, 31059
Clinique Pasteur
Toulouse, France, 31100
Clinique Saint Gatien
Tours, France, 37042
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

No publications provided

Responsible Party: Didier Carrié, Rangueil Hospital
ClinicalTrials.gov Identifier: NCT00300157     History of Changes
Other Study ID Numbers: 2004-06
Study First Received: March 7, 2006
Last Updated: January 3, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Stenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014