Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease (NCT00598637) | Clinical Trial Compass
CompletedPhase 4
Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease
Germany, Italy650 participantsStarted 2007-12
Plain-language summary
The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) 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 CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness.
* Pretreatment with a loading dose of 600 mg clopidogrel.
* Informed, written consent by the patients or her/his legally-authorized representative for participation in the study.
Exclusion Criteria:
* Cardiogenic shock.
* ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset.
* In-stent restenosis.
* Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance.
* Prior coronary artery bypass surgery with revascularization of LAD and/or LCx.
* Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days.
* An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment.
* Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media.
* Pregnancy (present, suspected or planned).
* Patient's inability to fully cooperate with the study protocol.
What they're measuring
1
Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.