Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 610
- 试验地点
- 6
- 主要终点
- The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation
研究概览
简要总结
The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting
详细描述
A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft 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% de novo stenosis located in CABG
- •Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
- •In women with childbearing potential a negative pregnancy test is mandatory
排除标准
- •Cardiogenic shock
- •Target lesion located in the native coronary vessels.
- •In-stent restenosis of CABG
- •Target lesion located at internal mammary artery graft or free arterial graft
- •Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- •Known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel.
- •Inability to take clopidogrel for at least 6 months.
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrollment in this trial.
- •Patient's inability to fully cooperate with the study protocol.
研究组 & 干预措施
DES
drug-eluting stents
干预措施: sirolimus-eluting stent (Device)
DES
drug-eluting stents
干预措施: paclitaxel-eluting stent (Device)
DES
drug-eluting stents
干预措施: biodegradable-polymer-based sirolimus-eluting stent (Device)
BMS
bare metal stents
干预措施: bare metal stents (Device)
结局指标
主要结局
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation
时间窗: 12 months
次要结局
- All cause death(12 months)
- Stent thrombosis(12 months)
- Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.(12 months)
- Myocardial infarction rate(12 months)