跳至主要内容
临床试验/NCT00783796
NCT00783796终止不适用

Spirit Small Vessel Registry (SPIRIT SV)

Abbott Medical Devices67 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年10月最近更新:
适应症
干预措施

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

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®

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (67)

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