Spirit Small Vessel Registry (SPIRIT SV)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 67
- 主要终点
- Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
研究概览
简要总结
To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.
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
- 18 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
研究组 & 干预措施
2.25mm XIENCE V®
Patients receiving the 2.25 mm XIENCE V® stent
干预措施: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (Device)
结局指标
主要结局
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
时间窗: 3 years
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
次要结局
- Target Vessel MI - Q-wave and Non Q-wave (Per ARC)(3 years)
- Cardiac Death/MI(3 years)
- All Coronary Revascularization (TVR and Non-TVR)(3 years)
- Clinically Indicated Target Vessel Revascularization(3 years)
- In-Stent Late Loss(240 days)
- Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)(From start of index procedure to end of index procedure)
- Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)(From the start of index procedure to end of index procedure)
- In-segment Late Loss (LL)(240 Days)
- Proximal Late Loss(240 days)
- Distal Late Loss(240 days)
- In-stent % Diameter Stenosis(240 days)
- Proximal % Diameter Stenosis(240 days)
- In-stent Angiographic Binary Restenosis (ABR) Rate(240 days)
- Clinically Indicated Target Vessel Revascularization (TVR)(30 days)
- Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)(3 years)
- Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)(3 years)
- All TVR (CI and Non-CI)(3 years)
- All TLR (CI and Non-CI)(3 years)
- Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)(3 years)
- In-segment % Diameter Stenosis(240 days)
- Distal % Diameter Stenosis(240 days)
- In-segment Angiographic Binary Restenosis (ABR) Rate(240 days)
- Stent Thrombosis (ARC Defined)(Overall (0 - 1123 days))
- Stent Thrombosis (Protocol Defined)(Overall (0 - 1123 days))
- All Death/ All MI/All Coronary Revascularization(3 years)
- Clinically Indicated Target Lesion Revascularization (CI-TLR)(3 years)
- Proximal Angiographic Binary Restenosis (ABR) Rate(240 days)
- Distal Angiographic Binary Restenosis (ABR) Rate(240 days)
- All Death (Cardiac, Vascular, Non-cardiovascular)(3 years)
- Cardiac Death/ All MI /CI-TLR(3 years)
