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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 5
- 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
研究组 & 干预措施
CardioGard Cannula
Experimental
干预措施: Aortic Cannulas (CardioGard) (Device)
Reference Cannula
Active Comparator
干预措施: Aortic Cannulas (CardioGard) (Device)
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 (5)
Loading locations...
相似试验
Unknown
2 期
BioFreedom US IDE Feasibility TrialIschemic Heart DiseaseSilent IschemiaUnstable AnginaStable AnginaNCT02131142Biosensors Europe SA72
已完成
不适用
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical ExcisionEarlobe KeloidsNCT01706861Halscion, Inc.51
已完成
不适用
A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic AstigmatismMyopic AstigmatismMyopiaNCT04111757Bausch & Lomb Incorporated168
No Longer Available
不适用
PRESERVE-Zenith® Branch Endovascular Graft-Iliac BifurcationAortoiliac AneurysmsIliac AneurysmsNCT02475798Cook Research Incorporated
撤回
不适用
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder ArthroplastyShoulder OsteoarthritisNCT02452957Stryker Trauma and Extremities