Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 试验地点
- 7
- 主要终点
- Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.
研究概览
简要总结
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.
详细描述
Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.
时间窗: 1 year follow-up
次要结局
- Angiographic restenosis at follow-up coronary angiography.(6-9 months follow-up)