NCT04899583招募中不适用
A Prospective, Multicenter, Random Controlled Clinical Trail to Evaluate the Effectiveness and Safety of Sirolimus Coated Balloon Versus a Paclitaxel Coated Balloon in the Treatment of Coronary Bifurcation Lesion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.
研究概览
简要总结
The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤75 years old
- •Diagnosed as stable or unstable angina pectoris, asymptomatic myocardial ischemia or old myocardial infarction, or recent myocardial infarction in stable stage.
- •Eligible for balloon dilatation or stent implantation.
- •Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
排除标准
- •AMI occurred within 7 days before operation
- •The subjects had congestive heart failure or the heart function was classified as NYHA/KillipIV.
- •Left ventricular ejection fraction (LVEF) < 35%
- •History of heart transplantation
- •The subjects had severe arrhythmias, such as high-risk ventricular extrasystole and / or ventricular tachycardia.
- •The subjects had stroke, gastrointestinal bleeding or active ulcers, or had a high risk of bleeding in the past 6 months.
- •Active bleeding physique or blood coagulation disorder
- •Known renal insufficiency（eGFR<30ml/min）
- •Contraindicated to anticoagulants or antiplatelet agents
- •Has a history of percutaneous coronary intervention (PCI) within 6 months before enrollment.
- •Has contraindications for coronary artery bypass grafting
- •known to be allergic to aspirin, heparin, contrast agents, paclitaxel and sirolimus
- •Life expectancy less than 12 months, or unable to complete a 12-month follow-up
- •Pregnant or lactating females, or who plan to become pregnant during a follow-up period of 1 year after operation
- •The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
- •Angiographic Inclusion Criteria:
- •One target lesion (bifurcation lesion) in the coronary artery is allowed, and if there are coexistent non-bifurcated lesions requiring PCI intervention, only one lesion was accepted at most, and the target lesion should be treated after successful PCI treatment of non-target lesion.
- •Target Lesion located in native coronary artery must be de novo
- •Medina classification should be (1.1.1, 1.0.1, 0.1.1)
- •Main branch of target lesion (%DS is ≥70% or ≥50% with clinical symptoms ) is suitable for stent implantation
- •Target Lesion located in main branch should be covered by DES. Moreover, the residual stenosis ≤ 30%, TIMI flow is 3, no complications and branch vessel opening stenosis ≥ 70%.
- •Reference vessel diameter of the branch is 2.0-4.0mm (by visual)
- •Target lesion length ≤ 36mm (by visual)
- •Angiographic Exclusion Criteria:
- •Target or non-target lesion located in left main
- •Subjects who have non-target lesions of bifurcation
- •The target lesion is trifurcation or multifurcation lesion.
- •Main branch of target lesion located within 3 mm from the ostium of LAD or LCx or RCA
- •The branch lesion is a diffuse long lesion, which could't covered by one DCB.
- •Main or side branch is occlusive lesion, which TIMI flow is
- •Aneurysm existed in the blood vessel at the target lesion
- •Side branch severely calcified or tortuous
- •The blood pressure was too low to tolerate intracoronary injection of ≥ 100ug nitroglycerin
- •Failure pre-dilatation of the side branch ostium (residual stenosis > 30% ,the blood flow in TIMI is not up to grade 3, or has dissection of type C or above according to NHLBI grade)
结局指标
主要结局
Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure.
时间窗: 9 months post procedure
Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)\*100% at 9 months post procedure.
次要结局
- Diameter stenosis rate(9 months post procedure)
- Rate of procedure success(Immediately after procedure)
- Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE）(30 days, 6 months, 9 months, 12 months post procedure)
- Rate of device success(Immediately after procedure)
- Rate of lesion success(Immediately after procedure)
- Late lumen loss (LLL)(9 months post procedure)
- Angiographic binary restenosis (ABR) rate(9 months post procedure)
- Rate of patient-related composite endpoints (PoCE）(30 days, 6 months, 9 months, 12 months post procedure)
- Rate of composite safety endpoint(12 months post procedure)
研究者
研究点 (1)
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