NCT03401203已完成不适用
A Prospective, Open Label, Multi-center, Dual Arm, Randomized Trial : The ROTA-ISR (Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis) Trial
Seung-Jung Park3 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2018年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 3
- 主要终点
- In-segment minimal lumen diameter on angiographic
研究概览
简要总结
This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 19 years of age
- •Subjects with coronary In-stent restenosis planned revascularization
- •In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Complex lesion anatomy that disables rotational atherectomy
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •Life expectancy < 1 years for any non-cardiac or cardiac causes
- •Unwillingness or inability to comply with the procedures described in this protocol.
结局指标
主要结局
In-segment minimal lumen diameter on angiographic
时间窗: 1 year
次要结局
- Device success rate(1 year)
- Angiographic outcomes immediate after procedure(1 hour)
- OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area(1 hour)
- OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume(1 hour)
- Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis(1 year)
- OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss(1 year)
- composite event rate(1 year)
研究者
Seung-Jung Park
Professor, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea
Asan Medical Center
研究点 (3)
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