NL-OMON56003招募中不适用
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter when used for Cerebral Perfusion During Aortic Arch Repair - Clinical Safety and Performance of the SP-GRIPFLOW
Fuji Systems0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Is willing and able to understand and sign informed consent, and has signed
- •an information and inform consent
- •Is male or female
- •Is minimum 18 years of age when signing the informed consent
- •Has been diagnosed with an aortic arch aneurysm or chronic dissection with an
- •indication for open arch repair.
- •Is indicated for elective open/hybrid aortic arch repair with cerebral
- •Is willing and able to comply to the schedule of assessment of the clinical
- •investigation
- •Has a target vessel diameter appropriate for the use of the SP-GRIPFLOW
- •Catheter (12Fr-16Fr)
排除标准
- •Aortic dissection or rupture which require acute surgery.
- •Emergency surgery.
- •American Society of Anesthesiologists (ASA) Class >IV
- •Is currently participating in, or has recently exited from (within 30 days
- •prior to screening for this clinical investigation), or plans to be enrolled
- •(during the course of this clinical investigation) in another clinical
- •investigation.
- •Had cerebral perfusion with another similar device/competitor device in the
- •last 30 days
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