I71
Conditions
Interventions
Group 1: This is a single-arm clinical investigation. Enrolled subjects will have cerebral perfusion with the investigational device during surgical repair of the aortic arch. A total of 1-3 investiga
Sponsors
FUJI SYSTEMS CORPORATION
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany, Netherlands
Contacts
Public ContactGuillaume Geuzebroek
RadboudUMC
Outcome results
None listed