NCT02632292终止不适用
EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
University of Luebeck2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- In-stent late lumen loss
研究概览
简要总结
Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.
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
- •DM type I or II based on the definitions of the American Diabetes Association
- •Angiographically proven CAD
- •Angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80
- •Negative pregnancy test in women with childbearing potential
- •Angiographic inclusion criteria:
- •De-novo lesion in at least one native coronary artery
- •Luminal diameter reduction 50-99% assessed by visual estimation
- •Target reference vessel diameter 2.5 - 4.0 mm
排除标准
- •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
- •Severe calcification of the target lesion as determined by angiography
- •In-stent restenosis
- •Bifurcation lesion with planned two-stent strategy
- •Chronic total occlusion
- •Indication for CABG
研究组 & 干预措施
Absorb GT1
Experimental
Bioresorbable everolimus-eluting scaffolds
干预措施: Absorb GT1 (Device)
Promus
Active Comparator
Everolimus-eluting stents
干预措施: Promus (Device)
结局指标
主要结局
In-stent late lumen loss
时间窗: Angiography 8-10 months after the index procedure
次要结局
- Device success(Baseline angiography)
- Cardiac death(12- and 24-months)
- In-segment late lumen loss(Angiography 8-10 months after the index procedure)
- Myocardial infarction(12- and 24-months)
- Scaffold/stent thrombosis(12- and 24-months)
- Target lesion failure(12- and 24-months)
- Procedure success(Baseline angiography)
- Vasomotion(Angiography 8-10 months after the index procedure)
- Binary restenosis(Angiography 8-10 months after the index procedure)
- Conformability(Angiography 8-10 months after the index procedure)
- Major adverse cardiac events(12- and 24-months)
- Target vessel revascularization(12- and 24-months)
- Target vessel failure(12- and 24-months)
- Clinical success(12- and 24-months)
- Anginal status assessed by the Seattle Angina Questionnaire(12- and 24-months)
研究者
Holger Thiele
Principal Investigator
University of Luebeck
研究点 (2)
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