NCT04896177招募中不适用
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
适应症
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.
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))
- 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))
- Target lesions revascularization (TLR)(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days))
研究者
研究点 (1)
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