NCT00562016终止3 期
PROTECT II: A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Abiomed Inc.
- 入组人数
- 452
- 试验地点
- 98
- 主要终点
- Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
研究概览
简要总结
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
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 is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
- •Patient presents with:
- •A compromised Ejection Fraction
- •Intervention on the last patent coronary conduit
- •Intervention on an unprotected left main artery or
- •Patient presenting with triple vessel disease.
排除标准
- •ST elevation M.I.
- •Pre procedure cardiac arrest within 24 hours.
- •Subject in cardiogenic shock
结局指标
主要结局
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
时间窗: 30 days +/- 10 days
次要结局
- Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.(In hospital events)
研究者
研究点 (98)
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