Status:
UNKNOWN
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
Lead Sponsor:
Fuji Systems Corporation
Collaborating Sponsors:
Avania
Conditions:
Aortic Aneurysm
Aortic Dissection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions. The information from this research will be used to help...
Detailed Description
The SP-GRIPFLOW catheter is a catheter that is used to transport blood from the aortic arch to your brain during surgery on the aorta. The procedure in which the catheter is used does not differ from ...
Eligibility Criteria
Inclusion
- 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 SPGRIPFLOW Catheter (12Fr, 14Fr or16Fr)
Exclusion
- 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
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT05421130
Start Date
May 2 2022
End Date
February 1 2024
Last Update
July 11 2023
Active Locations (5)
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1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Campus Freiburg: Hugstetter Straße 55, Germany, 79106
2
Universitätsklinikum Frankfurt
Frankfurt, Theodor-Stern-Kai 7,, Germany, 60590
3
Herzzentrum Leipzig GmbH
Leipzig, Universitätsklinik Für Herzchirurgie Strümpellstraße 39, Germany, 04289
4
St.Antonius Hospital
Nieuwegein, Koekoekslaan 1, 3435 CN, Netherlands