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临床试验/NCT01368471
NCT01368471已完成4 期

MASTER: MGUARD for Acute ST Elevation Reperfusion

InspireMD7 个研究点 分布在 2 个国家目标入组 433 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
InspireMD
入组人数
433
试验地点
7
主要终点
The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution

研究概览

简要总结

The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

结局指标

主要结局

The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution

时间窗: 60 to 90 minutes after the last angiogram

次要结局

  • Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure(discharge, 30 days, 6 and 12 months post-procedure)
  • The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.(60-90 minutes after last angiogram)

研究者

发起方
InspireMD
申办方类型
Industry
责任方
Sponsor

研究点 (7)

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