XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,010
- 试验地点
- 47
- 主要终点
- Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
研究概览
简要总结
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
详细描述
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
排除标准
- •Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
结局指标
主要结局
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
时间窗: From 2 years to 3 years
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent\&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise\&fall in cardiac biomarkers * Non-occlusive \&occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST\&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
次要结局
- Number of Participants With Adverse Events Related to Anti-platelet Medication(From 4 years to 5 years)
- Acute Gain(On day 0 after procedure)
- Number of Participants With All Deaths, TVMI and CI-TLR(From 2 Years to 3 Years)
- Number of Participants With Target Vessel Revascularization (TVR)(From 2 Years to 3 Years)
- Percent Diameter Stenosis (%DS)(At 8 months)
- Late Loss(On day 0 after procedure)
- Acute Success(On day 0 (Immediately post-index procedure))
- Net Gain(On day 0 after procedure)
- Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)(From 2 years to 3 years)
- Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)(From 2 Years to 3 Years)
- Number of Participants With All Deaths and All MI(From 2 Years to 3 Years)
- Number of Participants With Myocardial Infarctions (MI)(From 2 years to 3 years)
- Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)(From 2 Years to 3 Years)
- Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR(From 2 Years to 3 Years)
- Number of Participants With All Deaths, All MI and All Revascularization(From 2 Years to 3 Years)
- Number of Participants With Target Lesion Revascularization (TLR)(From 2 years to 3 years)
- Number of Participants With Cardiac Death and All MI(From 2 Years to 3 Years)
- Number of Participants With All Deaths, TVMI and TLR(From 2 Years to 3 Years)