NCT02325817已完成不适用
A Multicenter, Superior, Randomized Controlled Clinical Trial to Observe the Safety and Efficacy of Bingo Drug-eluting Balloon vs. Yinyi Balloon Dilatation Catheter in the Treatment of Patients With Bifurcation Stenosis Lesions of Coronary Artery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Target lesion Stenosis (diameter, %)
研究概览
简要总结
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.
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
- •Male or non-pregnant female ages 18-80 years old
- •Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction
- •Patients with bifurcation lesions of coronary artery observed by angiography.
- •The main branch of the vessels are suitable for PCI and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation.
- •De Novo bifurcation lesions and diameter stenosis are not less than70%;
- •Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm
- •Residual stenosis are not more than 50% after predilatation;
- •Patients who understand the purpose of this trial, voluntary and sign informed consent.
排除标准
- •Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty
- •Left main coronary artery lesions without protection or related bifurcation lesions
- •Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)
- •Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl；
- •Patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy;
- •Patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor)
- •Patients whose expected lives are less than 1 year;
- •Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.
- •In-stent restenosis lesions
- •Patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.
研究组 & 干预措施
Drug-eluting balloon
Experimental
Treat the side branch of bifurcation lesion with drug-eluting balloon
干预措施: Drug-eluting balloon (Device)
Uncoated balloon
Active Comparator
Treat the side branch of bifurcation lesion with uncoated balloon
干预措施: Uncoated ballloon (Device)
结局指标
主要结局
Target lesion Stenosis (diameter, %)
时间窗: 9 months
次要结局
- All-cause death(1, 6 and 9 months)
- Cardiac death(1, 6 and 9 months)
- TLR(1, 6 and 9 months)
- TVR(1, 6 and 9 months)
- TLF(1, 6 and 9 months)
- MACCE(1, 6 and 9 months)
- Non-fatal MI, thrombosis(1, 6 and 9 months)
- Thrombosis(1, 6 and 9 months)
研究者
研究点 (1)
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