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Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Percutaneous coronary intervention with Taxus stent
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Left main coronary artery stenosis, stent, Taxus, Unprotected left main coronary artery disease, Percutaneous coronary intervention with Taxus stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Polyclinique du Parc Rambot
  • Clinique Rhône Durance
  • Clinique Saint Augustin
  • Chu Brest
  • CHU CAEN
  • Hôpital Cardiologique
  • Clinique du Tonkin
  • Unité Cardio-Vasculaire
  • CHU NORD
  • Institut Hospitalier Jacques Cartier-ICPS
  • Hôpital Bon Secours
  • Clinique du Millénaire
  • Nouvelles Cliniques Nantaises
  • Hôpital privé Les Franciscaines
  • CHU Caremeau
  • Hôpital COCHIN
  • Institut Mutualiste Montsouris
  • Groupe Hospitalier La Pitié-Salpetrière
  • CHU Pontchaillou
  • Clinique Saint Hilaire
  • Hôpital Charles Nicolle
  • Institut Arnaud Tzanck
  • Centre Cardiologique du Nord
  • CHU Toulouse Rangueil
  • Clinique Pasteur
  • Clinique Saint Gatien

Outcomes

Primary Outcome Measures

Coronarography

Secondary Outcome Measures

Major cardio-vascular events

Full Information

First Posted
March 7, 2006
Last Updated
January 3, 2011
Sponsor
French Cardiology Society
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00300157
Brief Title
Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
French Cardiology Society
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
Left main coronary artery stenosis, stent, Taxus, Unprotected left main coronary artery disease, Percutaneous coronary intervention with Taxus stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Percutaneous coronary intervention with Taxus stent
Primary Outcome Measure Information:
Title
Coronarography
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Major cardio-vascular events
Time Frame
1, 18 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Carrié, MD-PhD
Organizational Affiliation
Rangueil Hospital Toulouse France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hélène ELTCHANINOFF, MD-PhD
Organizational Affiliation
Hôpital Charles Nicolle Rouen FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thierry LEFEVRE, MD
Organizational Affiliation
Hôpital Jacques Cartier ICPS Massy FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marc SILVESTRI, MD
Organizational Affiliation
Polyclinique du Parc Rambot Aix en Provence FRANCE
Official's Role
Study Chair
Facility Information:
Facility Name
Polyclinique du Parc Rambot
City
Aix-en-Provence
ZIP/Postal Code
13100
Country
France
Facility Name
Clinique Rhône Durance
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Clinique Saint Augustin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Chu Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU CAEN
City
CAEN Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Cardiologique
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique du Tonkin
City
Lyon
ZIP/Postal Code
69100
Country
France
Facility Name
Unité Cardio-Vasculaire
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU NORD
City
Marseille
ZIP/Postal Code
13326
Country
France
Facility Name
Institut Hospitalier Jacques Cartier-ICPS
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Hôpital Bon Secours
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Clinique du Millénaire
City
Montpellier
ZIP/Postal Code
34960
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hôpital privé Les Franciscaines
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
CHU Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital COCHIN
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier La Pitié-Salpetrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Clinique Saint Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Arnaud Tzanck
City
Saint Laurent du Var
ZIP/Postal Code
06700
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Facility Name
CHU Toulouse Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Clinique Saint Gatien
City
Tours
ZIP/Postal Code
37042
Country
France

12. IPD Sharing Statement

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Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

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