PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 28
- 试验地点
- 18
- 主要终点
- MACCE Events at 30 days or discharge, whichever is longer
研究概览
简要总结
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
排除标准
- •ST Myocardial Infarction
- •Cardiac Arrest
- •Cardiogenic Shock
- •Thrombus Left Ventricle
结局指标
主要结局
MACCE Events at 30 days or discharge, whichever is longer
时间窗: 30 days or discharge
Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.
Freedom from Hemodynamic compromise during PCI procedure
时间窗: During procedure
Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required
次要结局
- Other intra-procedural and peri-procedural adverse events(During treatment and out to 90 days)
- Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion(During procedure)
- Angiographic Success(Post-PCI)