Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter when used for Cerebral Perfusion During Aortic Arch Repair
- Conditions
- Aortic arch aneurysm10019280
- Registration Number
- NL-OMON56003
- Lead Sponsor
- Fuji Systems
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
• 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-16Fr)
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is defined by blood flow through the SP-GRIPFLOW and<br /><br>perfusion of the brain during open surgical repair of the distal aortic arch.<br /><br>Blood flow (and perfusion) is assessed by the flow rate through the cannula(s)<br /><br>compared to the target flow rate. Successful perfusion is defined when the flow<br /><br>rate through the catheter(s) equals the target flow rate (mL/kg/min). The<br /><br>perfusion flow rate will be monitored throughout the procedure. The target flow<br /><br>rate will be preoperatively defined by the investigator.</p><br>
- Secondary Outcome Measures
Name Time Method