NCT04626687招募中不适用
Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
适应症
干预措施
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
- Angiographic percent diameter stenosis
研究概览
简要总结
The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
详细描述
This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.
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
- •18 to 80 years of age
- •Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator
- •Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length.
- •Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.
- •Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.
排除标准
- •AMI within 1 week.
- •Subject has congestive heart failure or NYHA IV.
- •Subject with LVEF < 35%.
- •Subject has undergone heart transplantation.
- •Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.
- •Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding.
- •Subject with a history of leukopenia (white blood cell count of < 3×109/L for >3 days), neutropenia (ANC<1000/mm3 for >3 days) or thrombocytopenia (platelet <100,000/mm3).
- •Known renal insufficiency (eGFR<30 ml/min).
- •Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel.
- •Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up.
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- •Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
- •Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases.
- •Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.
研究组 & 干预措施
test DCB group
Experimental
use the DCB made by Acotec Scientific
干预措施: test DCB (Device)
RESTORE DCB group
Active Comparator
use the DCB made by CARDIONOVUM GmbH
干预措施: RESTORE DCB (Device)
结局指标
主要结局
Angiographic percent diameter stenosis
时间窗: at 9 months post-procedure
(1-Segmental minimum lumen diameter \[MLD\]/ segmental reference vessel diameter \[RVD\]) ×100%
次要结局
- Acute success(in the procedure)
- Late lumen loss(at 9 months post-procedure)
- Diameter stenosis in-device(at 9 months post-procedure)
- Rate of target lesion failure(within 12 months post-procedure)
研究者
研究点 (1)
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