Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 254
- 试验地点
- 2
- 主要终点
- late lumen loss （LLL）
研究概览
简要总结
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .
- •Reference vessel diameter ≥3.0 mm, and <4.5mm. Lesion length of ≤20 mm Written informed consent
排除标准
- •Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus
研究组 & 干预措施
DCB group by OCT guided
干预措施: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography (Device)
DES group by OCT guided
干预措施: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography (Device)
结局指标
主要结局
late lumen loss （LLL）
时间窗: Follow-up coronary angiography at 12 months after the procedure
late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD
次要结局
- The incidence rate of device-related ischemic events(Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure)
- The incidence rate of patient-related ischemic events(Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure)
研究者
Liu Bin
Director of cardiology department.
Second Hospital of Jilin University