XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Number of Participants With Stent Thrombosis: Late
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.
详细描述
Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.
The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Stent Thrombosis: Late
时间窗: 30 days to 1 year post stent implantation-Day 212
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
次要结局
- Number of Participants With Cardiac Death/All MI(0 to 5 years)
- Number of Participants With Cardiac Death or Target-Vessel MI(0 to 5 years)
- Mean Net Gain: In-stent, In-segment(At 8 months, post index procedure)
- Mean Reference Vessel Diameter (RVD)(During follow-up, at 8 months post procedure)
- Number of Participants With All Revascularization(0 to 5 years)
- Number of Participants With Death(0 to 5 years)
- Number of Participants With Target Lesion Revascularization Based on Ischemia Findings(0 to 5 years)
- Number of Participants With Cardiac Death(0 to 5 years)
- Number of Participants With MI Related to Target Vessel(0 to 5 years)
- Number of Participants With Target Vessel Failure (TVF)(0 to 5 years)
- Number of Participants With Target Vessel Revascularization (Non-TLR)(0 to 5 years)
- Percent Diameter Stenosis (%DS)(During follow-up, at 8 months post procedure)
- Number of Participants Using Antiplatelet Therapy(5 years observation day from the procedure day)
- Number of Participants With Myocardial Infarction(0 to 5 years)
- Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)(0 to 5 years)
- Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))(0 to 5 years)
- Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)(0 to 5 years)
- Number of Participants With Target Lesion Failure (TLF)(0 to 5 years)
- Mean Lesion Length(Pre-procedure)
- Number of Participants With Death/All MI(0 to 5 years)
- Mean Acute Gain: In-stent, In-segment(At 8 months, post index procedure)
- Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal(At 8 months, post index procedure)
- Minimum Blood Vessel Diameter(During follow-up, at 8 months post procedure)