H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
Intervention for coronary bifurcation lesion is about 10~20% of entire percutaneous coronary intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore, occlusion of side branch frequently occurred during PCI. Several techniques to prevent occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side branch stent is developed to treat coronary side branch lesion and composed of proximal, connecting and distal parts. In vivo study performed in pigs showed effective H-side branch stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of coronary side branch lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 20 years old
- •Patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion
- •Bifurcation lesion with 2.5~4.0mm of main vessel diameter, <30mm of main vessel length and ≥2.0mm of branched vessel diameter
排除标准
- •Acute myocardial infarction
- •Confirmed or suspicious presence of thrombus in target lesion
- •In-stent restenosis lesion
- •Visual angulation with ≥75°
- •Lesion with severe calcification or severe tortuosity
- •Left main lesion
- •Chronic total occlusion lesion
- •Graft lesion
- •Contraindication to antiplatelet drugs
- •Left ventricular dysfunction (LVEF ≤40%)
- •Severe hepatic dysfunction (≥2.5 times than reference of AST or ALT)
- •Renal dysfunction (serum Creatinine > 2.0mg/dL)
- •History of cerebral hemorrhage, pulmonary or gastrointestinal bleeding
- •Hypersensitivity of aspirin, clopidogrel or contrast media
- •Pregnant woman or possibility of pregnancy during clinical study period
结局指标
主要结局
Major adverse cardiovascular events
时间窗: During 6 months after implantation of H-side branch stent
composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, target lesion revascularization
次要结局
未报告次要终点