NCT04953117Unknown不适用
Assess the Safety and Efficacy of Lepu® Drug Coated Balloon Versus RESTORE® Paclitaxel Eluting Balloon for the Treatment of Coronary Small-vessel Disease: a Prospective, Multicenter, Randomized, Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 286
- 试验地点
- 14
- 主要终点
- In-segment late lumen loss(LLL)
研究概览
简要总结
This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
详细描述
This study include a small vessel cohort and a very small vessel cohort. In the small vessel cohort, patients with visually estimated reference vessel diameters(RVDs)≥2.0 and ≤2.75mm were randomly assigned to the Coronary Drug Coated Balloon Catheter Used in Small Vessels of Lepu Medical or the Restore DEB in a 1:1 ratio. The study was powered to detect the noninferiority of the DCB of Lepu Medical versus the Restore DEB for a primary endpoint of in-segment late lumen loss(LLL) at 9 months.
In the very small vessel cohort, patients with RVD≥1.75 and<2.0mm were treated with the DCB of Lepu Medical of an appropriate size.
All subjects will been followed up for 2 years to observe the occurrence of adverse events, so as to make an accurate and reliable evaluation of the safety of drug coated balloon catheters for coronary small vessels.
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)
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 must be 18-80 years, males or females.
- •Subject with stable angina, or unstable angina, or recent myocardial infarction (myocardial infarction occurred more than 7 days before enrolled into the group), or asymptomatic myocardial ischemia with evidence
- •Coronary angiopathy in situ with stenosis of more than 70% with visually estimated (or more than 50% combined with symptoms of ischemia, TIMI ≥ 1) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.0 mm and ≤ 2.75 mm in small vessel group,and ≤ 26 mm in length or RVD ≥ 1.75 mm and < 2.0 mm in very small vessel group, and ≤ 16 mm in length.
- •Target small vessel lesions are located on one or two different coronary arteries (RCA / LAD/ LCX). The number of target small vessel lesions on each coronary artery is no more than one, and each target small vessel lesion can only be treated with one test instrument
- •The number of non-target lesions requiring early interventional treatment is no more than two, and the distance between them and target lesions must be > 10 mm; Successful treatment of non target lesions is required before subjects are randomized and the test equipment(DCB) cannot be used for the treatment.
- •Subject can receive any type of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
- •Subject can understand the study objectives and voluntarily participate in and sign the informed consent; subject must agree to clinical follow-up and angiographic follow-up at 9 months.
排除标准
- •AMI within 1 week.
- •In stent restenosis, complete occlusion or severe calcification (unable to pre expand successfully with balloon)
- •Left main artery disease or bifurcation disease with diameter >2.00mm requiring interventional treatment
- •Evidence of massive thrombi in the target vessels
- •Severe heart failure (NYHA IV)
- •Severe renal failure (subject with GFR < 30ml / min or undergoing hemodialysis)
- •Subject with vein graft restenosis after bypass surgery or severe heart valve disease
- •Pregnant or nursing subjects
- •Life expectancy less than 12 months
- •Subject with bleeding tendency, history of active peptic ulcer, suffered stroke within the past 6 months, contraindications of antiplatelet preparation and anticoagulant treatment
- •Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
- •Subject has undergone heart transplantation
- •Known allergy to aspirin, clopidogrel, heparin, contrast media, and paclitaxel.
- •The investigator judged that the subject's compliance is poor and can not complete the study as required.
结局指标
主要结局
In-segment late lumen loss(LLL)
时间窗: 9 months
In-segment late lumen loss is defined as the change in minimal lumen diameter
次要结局
- The success rate of intervention treatment (%)(Device success,Lesion success ,Procedural success)(2-3 days)
- Definite or probable target lesion thrombosis(30 days,6,9 months,and 1,2 years)
- In-segment diameter stenosis(DS%)(9 months)
- Angiographic binary restenosis (ABR)(9 months)
- Target lesion failure (TLF)(30 days,6,9 months,and 1,2 years)
- Patient-oriented composite endpoint (PoCE)(30 days,6,9 months,and 1,2 years)
研究者
研究点 (14)
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