Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
This study has been completed.
Sponsor:
French Cardiology Society
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
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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) |
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
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 | |
| Institut Mutualiste Montsouris | |
| Paris, France, 75014 | |
| Groupe Hospitalier La Pitié-Salpetrière | |
| Paris, France, 75651 | |
| Hôpital COCHIN | |
| 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 | |
| Clinique Pasteur | |
| Toulouse, France, 31100 | |
| CHU Toulouse Rangueil | |
| Toulouse, France, 31059 | |
| 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 Coronary Artery Disease Myocardial Ischemia Coronary Stenosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases |
ClinicalTrials.gov processed this record on May 23, 2013