Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,537
- 试验地点
- 53
- 主要终点
- major adverse cardiac and cerebrovascular events (MACE)
研究概览
简要总结
Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI between patients receiving Nobori versus uncoated stents.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age more than 20 years old
- •chest pain lasting more than 20 min
- •symptoms beginning within 12 hours before characterization
- •electrocardiogram showing ST-segment elevation or new appearance of left bundle branch block
- •increase in cardiac enzymes to more than 5-fold the normal laboratory values
- •infarct-related vessel are anatomically suitable for percutaneous revascularization
- •patients gave their signed, informed consent
排除标准
- •previous stent implantation within 30 days
- •allergy to any of the followings : aspirin, heparin, clopidogrel, biolimus A9 or its derivatives, stainless steel 316L, PLA (Poly-Lactic Acid) Polymer or its derivatives, and contrast media
- •elective surgery scheduled within 6 months
- •renal insufficiency with creatinine level of more than 2.5 mg/dL
- •patients associated with bleeding and/or clotting disorders, and those refusing blood transfusion
- •history of massive gastrointestinal or urinary tract bleeding within 6 months
- •patients currently enrolled in other clinical trials
- •pregnancy
研究组 & 干预措施
Uncoated stents
subjects receiving uncoated stent implantation
干预措施: uncoated stent (Procedure)
Nobori
subjects receiving Biolimus A9 eluting stent implantation
干预措施: Biolimus A9 eluting stents (Device)
结局指标
主要结局
major adverse cardiac and cerebrovascular events (MACE)
时间窗: 1 year
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
次要结局
- major adverse cardiac and cerebrovascular events (MACE)(1 week)
- target lesion revascularization(1 year)
- stent thrombosis(1 week and 1 year)
研究者
Shigeru Saito
Director, Cardiology, Shonan Kamakura General Hospital
NAUSICA Investigators