NCT01554709已完成2 期
A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- DWI- Diffusion Weighted Imaging
研究概览
简要总结
The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
- •Non pregnant female
排除标准
- •Contraindication for open heart surgery under bypass machine
- •Emergency Operation
结局指标
主要结局
DWI- Diffusion Weighted Imaging
时间窗: The outcome measure is assessed in average a week after the surgery
diffusion weighted magnetic resonance imaging (DW-MRI)
次要结局
- TCD- Transcranial Doppler(The Outcome measure is assessed during the surgery)
研究者
研究点 (6)
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