Status:
COMPLETED
Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Technical University of Munich
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
With the advent of coronary stents and improvements in periprocedural antithrombotic regimen, the spectrum of indications of percutaneous coronary interventions has continuously expanded for patients ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT00133237
Start Date
July 1 2005
End Date
June 1 2008
Last Update
March 15 2010
Active Locations (2)
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1
Deutsches Herzzentrum
Munich, Germany, 80636
2
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675