Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN) (NCT00133237) | Clinical Trial Compass
CompletedPhase 4
Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)
Germany607 participantsStarted 2005-07
Plain-language summary
The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% stenosis located in unprotected LMCA who are unable to undergo coronary artery bypass graft (CABG)
* Pretreatment with a loading dose of 300-600 mg clopidogrel
* Informed, written consent
Exclusion Criteria:
* Cardiogenic shock;
* ST-segment elevation acute myocardial infarction within 48 h from symptom onset;
* In-stent restenosis;
* Malignancies or other comorbid conditions with life expectancy less than one year;
* Prior coronary artery bypass surgery with revascularization of left anterior descending (LAD) and/or left circumflex (LCx) coronary artery
* Planned staged percutaneous coronary intervention (PCI) procedure within 30 days from index procedure or prior PCI within the last 30 days
* Left main size \>4.5mm
* An elective surgical procedure is planned during the first six months post enrolment;
* Known allergy to the study medications
* Pregnancy
* Patient's inability to fully cooperate with the study protocol
What they're measuring
1
Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year