Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent (NCT00300157) | Clinical Trial Compass
CompletedPhase 3
Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
France155 participantsStarted 2005-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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