NCT01711931已完成4 期
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Lumen Late Loss
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.
The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective PCI
- •ability and willingness to provide written informed consent
排除标准
- •ST-elevation myocardial infarction in the previous 48 hours
- •moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and <30ml/min respectively)
- •known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication
结局指标
主要结局
Lumen Late Loss
时间窗: 9 months
as assessed by quantitative coronary angiogram
次要结局
- Device-oriented major adverse cardiac events(6 months, 1, 2, 5 years)
- Patient-oriented major adverse cardiac events(6 months, 1, 2, 5 years)
研究者
Stéphane Cook, Prof
Principal Investigator
University of Freiburg
研究点 (2)
Loading locations...
相似试验
Unknown
3 期
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary SyndromeAcute Coronary SyndromeNCT00819923The Hospital District of Satakunta825
已完成
4 期
Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial InfarctionMyocardial InfarctionNCT01347554Yonsei University461
已完成
不适用
Everolimus- Versus Biolimus-Eluting Stents in All-ComersCoronary Artery DiseaseNCT01472705University of Freiburg814
已完成
3 期
Everolimus Stent in Patients With Coronary Artery Disease (CAD)Coronary AtherosclerosisCoronary Artery DiseaseNCT01182649San Giuseppe Moscati Hospital600
已完成
不适用
ABSORB STEMI: the TROFI II StudyAcute ST Segment Elevation Myocardial InfarctionNCT01986803ECRI bv191