Clinical Investigation of Clinical Safety and Performance of the SP- GRIPFLOW, Selective Cerebral Perfusion Catheter when used for Cerebral Perfusion During Aortic Arch Repair

FUJI SYSTEMS CORPORATIO0 个研究点目标入组 149 人开始时间: 2022年5月10日最近更新: 2024年8月19日

适应症

试验速览

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•Subjects shall fulfil all of the following criteria:
•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 perfusion
•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, 14Fr or 16Fr)

•Subjects shall fulfil none of the following criteria:
•Aortic dissection or rupture which requires 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 that may affect the endpoints of this clinical investigation.
•Had cerebral perfusion with another similar device/competitor device.

发起方

FUJI SYSTEMS CORPORATIO