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
- 8
- 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
Key inclusion criteria: > 18 years of age, 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%).
Key exclusion criteria: 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: iopromide), Patients with an ejection fraction of < 30 %, Reference vessel diameter (RVD) < 2.5 mm, Contraindication for whichever necessary accompanying medication.
Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)
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)
盲法说明
angiographies blinded to treatment groups
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
Control intervention
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: PTCA of coronary de novo lesion PCB (Device)
Experimental intervention
Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)
干预措施: PTCA of coronary de novo lesion SCB (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
- Procedural Success(in hospital)
- MACE MACE(at 6 and at 12 months)