JPRN-UMIN000005476已完成4 期
Optimal Duration of DAPT Following Treatment with Endeavor (Zotarolimus-Eluting Stent) in Real-World Japanese Patients: A Prospective Multicenter Registry - OPERA Study
PO Associations for Establishment of Evidence in Interventions0 个研究点目标入组 2,400 人开始时间: 2011年4月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Clinical exclusion criteria: 1.Patient over age 85 2.Patient with ST elevation MI who requires primary or rescue PCI and whose performance status falls under any of the exclusion criteria 3.Patient with cardiogenic shock 4.Patient who underwent stent treatment with BMS in other lesions within 6 months prior to the conduct of index PCI of the target vessel 5.Patient who has undergone some treatment with DES for coronary lesions 6.Patient who is scheduled to undergo elective surgery within 12 months after index PCI 7.Patient whose left ventricular ejection fraction (LVEF) is < 40% 8.Patient with a hemorrhagic predisposition or a history of coagulation abnormality 9.Patient in whom the total number of deployed stents exceeds 4, regardless of the number of lesions and the number of affected branches 10.Patient with a verified history of CVA before stenting 11.Patient with a verified history of active peptic ulcer or upper gastrointestinal tract bleeding before stenting 12.Patient showing impaired renal function (serum creatinine concentration: > 1.8 mg/dL) 13.Patient with known contraindications for aspirin or clopidogrel (the physician should assess tolerability within the range of routine medical care) 14.Patient with a known disorder who has a life expectancy of less than 12 months 15.Patient who is incompetent to adhere to all clinical FUs listed in the present protocol. Angiographic exclusion criteria: 1.Lesions located within the saphenous venin graft (SVG) 2.Unprotected lesions in the left coronary trunk 3.Lesions of in-stent restenosis in previously deployed DES or BMS 4.Lesions with an anatomical structure of the coronary artery that is not eligible for treatment by the deployment of Endeavor ZES
研究者
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