A Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Trial to Evaluate the Efficacy and Safety of Sirolimus Drug-eluting Coronary Balloon Catheter in Treatment of Coronary Bifurcation Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Stenosis of lumen diameter of target lesion branch
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions.
This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.
详细描述
The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions.
This is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. Paticipants with would undergoing PCI with sirolimus DEB or paclitaxel DEB, and be followed-up to 24 months.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female that ages 18-85 year old;
- •Having evidence of myocardial ischemia;
- •Voluntarily participates in this study and signs the informed consent form (ICF);
- •Sufficiently compliant with the study protocol and agreed to receive follow-up at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days, of which angiography was required at 9 months ±30 days;
- •Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;
- •Suitable for PCI and side-branch lesions are not expected to stent implantation, and no drug-eluting balloon used for the main-branch. If a stent is implanted into the main-branch, it's usually necessary to perform a final balloon kissing on the two branches;
- •Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;
- •The target vessel diameter was 2.0mm-4.0mm.
排除标准
- •Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;
- •Cardiogenic shock patients;
- •With hemorrhagic symptoms or active gastrointestinal ulcers, or previous stroke within 6 months, or who are expected to be unable to tolerate double-antibody therapy after interventional therapy;
- •ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;
- •With severe congestive heart failure or NYHA class Ⅳ heart failure;
- •With severe valvuar heart disease;
- •Heart transplant patients;
- •With renal insufficiency (creatinine > 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;
- •With a life expectancy less than 1 year;
- •With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;
- •With known allergies to paclitaxel, sirolimus, contrast agents, etc.;
- •Participating in clinical trials of other drugs or devices and has not met the primary endpoint;
- •Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;
- •Intra-stent restenosis;
- •High-risk left main disease;
- •Other patients considered by the investigator to be unsuitable for inclusion.
研究组 & 干预措施
Sirolimus drug-eluting coronary balloon catheter
Manufacturer: Shenzhen Salubris Pharmaceuticals Co., Ltd. This product is a sirolimus drug eluting balloon catheter for coronary artery therapy. It is a rapidly exchangeable PTCA balloon catheter (RX), effective length is 140cm, and compatible with 0.014 in. (0.36mm) guide wire. The balloon at the distal end of the catheter was coated with sirolimus, an anti-proliferative and anti-inflammatory drug.
干预措施: Sirolimus drug-eluting coronary balloon catheter (Device)
Drug-eluting balloon catheter
Manufacturer: Liaoning Yinyi Biotechnology Co., Ltd Coated with paclitaxel.
干预措施: Paclitaxel drug-eluting coronary balloon catheter (Device)
结局指标
主要结局
Stenosis of lumen diameter of target lesion branch
时间窗: 9 months (±30 days)
The degree of lumen diameter stenosis (%) =(1- the minimum lumen diameter of the vessel/the reference diameter of the target lesion vessel)×100%
次要结局
- Success rate of interventional treatment(Index Procedure)
- Target lesion failure rate (TLF)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))
- Target lesions revascularization (TLR)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))
- Late lumen loss (LLL)(9 months (±30 days))
- Incidence of restenosis of target lesions(9 months (±30 days))
- Target vessel revascularization (TVR)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))