Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

NCT00300157 | Completed Phase 3 DMC

• 1 other identifier: 2004-06
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 26

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.

Conditions

Coronary Arteriosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Coronarography

  9 months

Secondary Outcomes (1)

• Major cardio-vascular events

  1, 18 and 36 months

Interventions

Percutaneous coronary intervention with Taxus stent DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• Boston Scientific Corporation: collaborator

Study Sites (26)

Polyclinique du Parc Rambot

Aix-en-Provence, 13100, France

Location

Clinique Rhône Durance

Avignon, 84082, France

Location

Clinique Saint Augustin

Bordeaux, 33000, France

Location

Chu Brest

Brest, 29609, France

Location

CHU CAEN

Caen, 14033, France

Location

Hôpital Cardiologique

Lille, 59037, France

Location

Clinique du Tonkin

Lyon, 69100, France

Location

Unité Cardio-Vasculaire

Marseille, 13009, France

Location

CHU NORD

Marseille, 13326, France

Location

Institut Hospitalier Jacques Cartier-ICPS

Massy, 91300, France

Location

Hôpital Bon Secours

Metz, 57000, France

Location

Clinique du Millénaire

Montpellier, 34960, France

Location

Nouvelles Cliniques Nantaises

Nantes, 44000, France

Location

Hôpital privé Les Franciscaines

Nîmes, 30000, France

Location

CHU Caremeau

Nîmes, 30029, France

Location

Hôpital COCHIN

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Groupe Hospitalier La Pitié-Salpetrière

Paris, 75651, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Institut Arnaud Tzanck

Saint-Laurent-du-Var, 06700, France

Location

CHU Toulouse Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31100, France

Location

Clinique Saint Gatien

Tours, 37042, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Didier Carrié, MD-PhD

  Rangueil Hospital Toulouse France

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: December 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2011-01

Locations

FR (26)