NCT04842838尚未招募不适用
Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of Participants with Target lesion failure (TLF)
研究概览
简要总结
The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old;
- •Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;
- •Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);
- •Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;
- •Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;
- •Visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with NHLBI classification A, B, C type.
- •If 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion.
排除标准
- •Main branch or branching target lesions require treatment with more than one device (DES or DCB);
- •There is more than 1 non-target lesion requiring intervention on the target blood vessel;
- •The distance between non-target lesion and target lesion is less than 10 mm;
- •Main and branch lesions > 26 mm or branch lesions length BBB> mm;
- •Left main lesion and its bifurcation lesion;
- •Intra-stent restenosis or severe calcification;
- •ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;
- •Severe heart failure (NYHA-IV or left ventricular ejection fraction <35%);
- •Cardiogenic shock;
- •known to have renal failure (EGFR <30ml/min/1.73m2);
- •Pregnant or lactating women, or women of reproductive age who had family planning or were unable to take adequate contraceptive measures during the study period;
- •Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study;
- •Other DES or DCB treatment contraindications;
- •Failing to sign an informed consent or having an expected life of less than 12 months;
- •Other researchers consider it inappropriate to participate in this study.
研究组 & 干预措施
DCB strategy
Experimental
干预措施: paclitaxel DCB (Device)
DES strategy
Active Comparator
干预措施: DES (Device)
结局指标
主要结局
Number of Participants with Target lesion failure (TLF)
时间窗: 12 months
Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization.
Number of Participants with net adverse clinical cardiovascular events (NACCE)
时间窗: 12 months
Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding)
次要结局
- Technical success rate(1-2 days)
- DAPT using time(1/6/12/24/36 month)
- Clinical procedure time(during the procedure)
- Number of Participants with ARC defines stent thrombosis(1/6/12/24/36 month)
- Number of Participants with Bleeding events（BARC2, 3, and 5）(1/6/12/24/36 month)
- Number of Participants with Target lesion failure (TLF)(1/6/24/36 month)
- Number of Participants with Target lesion revascularization (TLR)(1/6/12/24/36 month)
- Number of Participants with Target vessel revascularization (TVR)(1/6/12/24/36 month)
研究者
研究点 (1)
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