Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Late luminal loss at follow-up angiography
研究概览
简要总结
For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.
详细描述
Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES
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
- Single (Outcomes Assessor)
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% re- stenosis after prior implantation of Sirolimus eluting stents in native coronary vessels
- •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
- •Acute myocardial infarction within the first 48 hours from symptom onset.
- •Target lesion located in the left main trunk or bypass 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.
- •Allergy to antiplatelet therapy, sirolimus, paclitaxel, stainless steel.
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrollment in this trial.
- •Patient's inability to fully comply with the study protocol.
结局指标
主要结局
Late luminal loss at follow-up angiography
时间窗: 6-8 months
次要结局
- Need of target lesion revascularization.(12 months)
- Combined incidence of death or myocardial infarction.(12 months)
- Incidence of stent thrombosis.(12 months)
- Incidence of binary restenosis at follow-up angiography(6-8 months)