NCT06441539尚未招募不适用
Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions: a Prospective, Multi-center, Randomized, Non-inferiority Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 218
- 主要终点
- in-segment late lumen loss in main branch
研究概览
简要总结
Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial
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 to 80
- •Patients with chronic stable coronary artery disease, or unstable angina, or NSTEMI (Grace score<140), or STEMI more than one week
- •Subjects suitable for PCI
- •Subjects understand the trial purpose, volunteer to participate and sign informed consent form
- •Angiographic Inclusion Criteria (by visual):
- •One coronary de novo bifurcation lesion (including Medina classification: 1,1,1 / 1,0,1 / 0,1,1, which need to be treated for both main and side branches)
- •The reference vessel diameter of main branch is between 2.5 to 4.0 mm, length ≤ 30 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%, or ≥50% with evidence of myocardial ischemia
- •The reference vessel diameter of side branch is ≥2.0 mm, length <20 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%
- •No more than 3 lesions on the non-target vessel in the same operation, and shall be successfully treated before the target vessel
- •No more than 1 non-target lesion on the target vessel in the same operation, and shall be successfully prepared before the target lesion (successful preparation of non-target lesion is defined as residual stenosis ≤30% and TIMI flow 3). After randomization, the non-target lesion shall be treated according to the assigned group, for the experimental group, using the experimental DCB is recommended; for the control group, using DES is recommended; Independent lesion on the same coronary artery is defined as interval >5 mm
- •The target lesions of main and side branches must be successfully prepared (successful preparation is defined as: residual stenosis ≤30% , without NHLBI type C or above dissection, and TIMI flow 3)
排除标准
- •Severe heart failure (NYHA IV), cardiogenic shock or severe valvular heart disease
- •Left ventricular ejection fraction ≤35%
- •Severe renal insufficiency (eGFR <30 ml/min)
- •Severe liver insufficiency (glutamate transaminase (ALT) or glutamate transaminase (AST) >3 times the upper limit of normal)
- •Pregnant women or planned pregnancy
- •With a known allergy to heparin, contrast agent, paclitaxel and everolimus
- •Unable to receive antiplatelet agents and anticoagulants, bleeding tendency or coagulopathy
- •Life expectancy does not exceed 1 year
- •Participating in other drug or device clinical trials without reaching the primary endpoint
- •Subjects who had undergone coronary revascularization in the last 6 months
- •Subjects not eligible by the investigator for other reasons
- •Angiographic Exclusion Criteria (by visual):
- •In-stent restenosis lesion
- •Left main bifurcation lesion
- •Chronic total occlusive lesion
- •Target vessel is severely distorted, angulated or calcified, which is anticipated difficult to cross for balloon or stent
- •Target lesion remains significant residual thrombus after preparation
结局指标
主要结局
in-segment late lumen loss in main branch
时间窗: 9 months
use quantitative coronary angiography by an independent core laboratory
次要结局
- Procedure success rates(up to 7 days in-hospital)
- Dissection and type(9 months)
- in-segment late lumen loss in side branch(9 months)
- Binary restenosis(9 months)
- Minimal lumen diameter(9 months)
- Stroke(1, 6, 9 and 12 months)
- Diameter stenosis(9 months)
- Target lesion failure(1, 6, 9 and 12 months)
- Target lesion thrombosis(1, 6, 9 and 12 months)
- BARC bleeds(1, 6, 9 and 12 months)
- Myocardial infarction(Peri-operation and 12 months)
- Death(1, 6, 9 and 12 months)
- Major Adverse Cardiovascular Events(1, 6, 9 and 12 months)
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