NCT02292823终止不适用
e-MASTER Registry: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- InspireMD
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Complete ST-segment resolution
研究概览
简要总结
Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is >18 years of age.
- •Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of >30 minutes and <24 hours.
- •Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
- •Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
- •The target lesion is a de novo lesion in a native coronary artery.
- •The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.
排除标准
- •Subject undergoing cardiopulmonary resuscitation.
- •Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
- •Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- •Target lesion involves a bifurcation with a side branch >/=2.0 mm in diameter.
- •In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.
结局指标
主要结局
Complete ST-segment resolution
时间窗: 1 day
All cause death or MI at 30 days
时间窗: 30 days
次要结局
- Acute success rates(1 day)
- TIMI flow grade(1 day)
- Stent thrombosis rate(Discharge, 30 days, 6 months,12 months)
- Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)(Discharge, 30 days, 6 months, 12 months)
研究者
研究点 (1)
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