Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InnoRa GmbH
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- late lumen loss in-segment
研究概览
简要总结
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
详细描述
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical 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 (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
- •Clinical evidence of stable or unstable angina or a positive functional study
- •Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia)
- •Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%)
排除标准
- •Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
- •Intolerance and / or allergy to Sirolimus
- •Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:
- •Patients with an ejection fraction of < 30 %
- •Reference vessel diameter (RVD) < 2.5 mm
- •Contraindication for whichever necessary accompanying medication
研究组 & 干预措施
PTCA of coronary de novo lesion PCB
Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)
干预措施: PCB PTCA (Device)
PTCA of coronary de novo lesion SCB
Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)
干预措施: SCB PTCA (Device)
结局指标
主要结局
late lumen loss in-segment
时间窗: 6 months
angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline
次要结局
- MACE(at 6 and at 12 months)
- Procedural success(5 days)