Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- late lumen loss in-segment
研究概览
简要总结
The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.
详细描述
Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.
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 (Participant)
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
- •>18 years of age
- •clinical evidence of stable or unstable angina or a positive functional study
- •patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)
排除标准
- •acute myocardial infarction within the past 72 hours
- •chronic renal insufficiency with serum creatinine levels >2.0 mg per deciliter%
- •known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
- •concomitant medical illness associated with a life-expectancy of less than two years
- •stented segment length ≥30 mm, vessel diameter <2.5 mm, diameter stenosis <70%
结局指标
主要结局
late lumen loss in-segment
时间窗: 6 months
angiographic late lumen loss in-segment assessed by quantitative coronary angiography
次要结局
- Major adverse cardiovascular events(6 months)
- Procedural Success(participants will be followed for the duration of hospital stay, an expected average of 2 days)