Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 410
- 试验地点
- 2
- 主要终点
- Side branch(SB) loss and PCI related myocardial infarction
研究概览
简要总结
This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).
详细描述
- Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
- Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
- Study design: This is a multi-center, prospective, randomized study.
- Methods
4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.
4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤75 years;
- •De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) >2.5mm while side branch <2.5mm and >1.5mm;
- •Only one bifurcation lesion need to be treated in one vessel;
- •The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%;
- •Signed consent is obtained.
排除标准
- •Left ventricular ejection fraction(LVEF) less than 30%;
- •Hemodynamic instability or cardiac shock;
- •Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
- •Tumor with expected survival less than 1 year;
- •Autoimmune disease;
- •Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
- •Acute coronary syndrome require emergency PCI;
- •Coronary bifurcation need to be treated with two-stent strategy;
- •Not suitable for drug-eluting stent(DES) implantation;
- •Mental disorder or alcohol dependence;
- •PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;
- •Target lesion is in-stent restenosis;
- •Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.
结局指标
主要结局
Side branch(SB) loss and PCI related myocardial infarction
时间窗: Within 48 hours after PCI
The primary outcome of the study is a composite of SB loss or PCI related myocardial infarction. According to Thrombolysis in Myocardial Infarction (TIMI) flow grading system, SB loss is defined as less than TIMI 3 flow immediately following MB stenting. It is considered temporary SB loss if TIMI 3 flow is restored with angioplasty and/or stenting. Otherwise, SB loss is considered permanent. In patients with normal (≤99th percentile URL) baseline cardiac troponin(cTn) concentrations, PCI related myocardial infarction is defined as elevations of cTn \>5× 99th percentile URL occurring within 48 hours of the procedure, which should be accompanied with other evidence of myocardial injury. A rise of \>20% is required for the diagnosis of PCI related myocardial infarction if the baseline cTn values are elevated and are stable or falling.
次要结局
- Major adverse cardiovascular events(MACEs)(Within 1 year after PCI)
- PCI related complication(Immediately after PCI)