Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- In-stent late lumen loss assessed by angiography
研究概览
简要总结
The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.
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
- •Clinical inclusion criteria:
- •Age ≥18 years
- •Angina pectoris, equivalent symptoms, and/or positive stress test
- •Viable myocardium subtended by chronic total occlusion
- •Negative pregnancy test in women with childbearing potential
- •Angiographic inclusion criteria:
- •Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months
- •Successful wire passage and assumption of successful stent/scaffold deployment
- •Target reference vessel diameter 2.5 - 4.0 mm
排除标准
- •Clinical exclusion criteria:
- •Limited long-term prognosis with a life-expectancy <12 months
- •Contraindications to antiplatelet therapy
- •Known allergy against cobalt chrome, everolimus, or polylactic acid
- •Angiographic exclusion criteria:
- •Target lesion located in the left main trunk
- •Target lesion located in a coronary bypass graft
- •Bifurcation lesion with planned two-stent strategy
- •Indication for coronary artery bypass grafting
研究组 & 干预措施
Bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
干预措施: Everolimus-eluting bioresorbable vascular scaffold (Device)
Stent
Implantation everolimus-eluting stent in chronic total occlusion
干预措施: Everolimus-eluting stent (Device)
结局指标
主要结局
In-stent late lumen loss assessed by angiography
时间窗: 8-10 months after the index procedure
次要结局
未报告次要终点
研究者
Holger Thiele
Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck
University of Luebeck