Status:
COMPLETED
Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 diseas...
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 dramatic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00300157
Start Date
December 1 2005
End Date
January 1 2010
Last Update
January 4 2011
Active Locations (26)
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1
Polyclinique du Parc Rambot
Aix-en-Provence, France, 13100
2
Clinique Rhône Durance
Avignon, France, 84082
3
Clinique Saint Augustin
Bordeaux, France, 33000
4
Chu Brest
Brest, France, 29609