NCT01418794Unknown4 期
Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
Shenyang Northern Hospital4 个研究点 分布在 1 个国家目标入组 606 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 606
- 试验地点
- 4
- 主要终点
- 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
研究概览
简要总结
Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18-85 years old, male or nonpregnant women
- •asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients
- •at least one target lesion length ≥ 20 mm (Visual method)
- •Target lesion diameter 2.5mm-4.0 mm (Visual method)
- •Target lesion diameter stenosis ≥ 70%
- •Patients who has indications for coronary artery bypass graft (CABG) surgery
- •Patients who is voluntary, understand the purpose of the study, willing to accept angiography and clinical follow-up
排除标准
- •Acute myocardial infarction for less than 1 week
- •Bridge vascular disease
- •In-stent restenosis lesions
- •Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet
- •Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal
- •Life expectancy is less than 12 months
- •Patient who has participated in other clinical trials but does not meet the deadline of the primary endpoint
- •Poor patient compliance
- •Heart transplant recipient
- •Patient who had other stent implanted within 1 year
- •Patient who has multi-vessel disease(Long lesions) and has already received other stent implantation
结局指标
主要结局
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
时间窗: 270 days
次要结局
- Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment(270 days)
- Composite end point of major adverse cardiac events(MACE)(30 days, 6 months, 9 months, 1 year)
- Stent thrombosis events after PCI for 24 hours, 30 days and 1 year(24 hours, 30 days and 1 year)
- Success rate of stent implantation(1 year)
研究者
研究点 (4)
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