NCT00972270终止3 期
RECOVER II Trial: A Prospective Randomized Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Abiomed Inc.
- 入组人数
- 1
- 试验地点
- 11
- 主要终点
- Composite rate of major adverse events within 30 days or hospital discharge.
研究概览
简要总结
This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •Subject presenting with STEMI undergoing primary PCI
- •Patient presents with at least 1 of the following:
- •Unstable blood pressure
- •Tachycardia and tissue hypoperfusion
- •The need for intravenous pressor or inotropic support
- •Patient presents with STEMI:
- •CK-MB>2x normal
排除标准
- •Unwitnessed cardiac arrest
- •Abnormalities of the aorta
- •Recent stroke or TIA
- •Mural thrombus in the left ventricle
研究组 & 干预措施
IMPELLA LP 2.5
Experimental
干预措施: Impella LP 2.5 (Device)
Intra-Aortic Balloon Pump
Active Comparator
干预措施: Intra-Aortic Balloon Pump (Device)
结局指标
主要结局
Composite rate of major adverse events within 30 days or hospital discharge.
时间窗: 30 days or discharge
Composite rate of major adverse events within 30 days or hospital discharge.
次要结局
- Maximum CPO increase from baseline.(Treatment)
研究者
研究点 (11)
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