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

Not Applicable

Recruiting

Conditions: I71
Aortic aneurysm and dissection

Registration Number: DRKS00028783

Lead Sponsor: FUJI SYSTEMS CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 149

Inclusion Criteria

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)

Exclusion Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is defined by blood flow through the SPGRIPFLOW and perfusion of the brain during open surgical repair of the distal aortic arch. Blood flow (and perfusion) is assessed by the flow rate through the cannula(s) compared to the target flow rate. Successful perfusion is defined when the flow rate through the catheter(s) equals<br>the target flow rate (mL/kg/min). The perfusion flow rate will be monitored throughout the procedure. The target flow rate will be preoperatively defined by the investigator.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint of this study will focus on assessment of adequate flow rate through the SP-GRIPFLOW. Whether the SPGRIPFLOW allows for an adequate flow rate will be assessed by a clinically relevant flow through the catheter(s) (mean and maximum flow rate). A clinically relevant perfusion flow rate of 10-15 mL/min/kg was defined from scientific literature.