Aortic arch aneurysm
Conditions
Interventions
 
Surgery for aortic arch pathology will be performed in accordance with the 
applicable treatment protocol(s) at the investigational site. The clinical 
study intervention consists of the use of the investigational device, the 
SP-GRIPFLOW Catheter. The SP-GRIPFLOW Catheter will be placed in the target 
artery for cerebral perfusion (e.g. left common carotid artery).The 
investigator will decide for unilateral (through the brachiocephalic trunk or 
left common carotid artery) or bilateral perfusion strategy (combination of 
brachiocephalic trunk, left subclavian artery and left common carotid artery). 
In addition, the investigator will define a target flow rate for cerebral 
perfusion (mL/min/kg). 
Sponsors
Fuji Systems
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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-16Fr)
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined by blood flow through the SP-GRIPFLOW 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 SP-GRIPFLOW 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. The safety of the SP-GRIPFLOW Catheter will be assessed by the nature, severity and incidence of adverse events at 30-days post-procedure. The adverse events found for the SP-GRIPFLOW will be compared to the current knowledge and state of the art to assess whether the device is associated with acceptable safety outcomes. The following intraoperative parameters will be assessed as exploratory endpoints: • Number of catheter dislocations from target artery • Near-infrared spectroscopy (O2 saturation) • Perfusion pressure (mmHg): o Line pressure o Pressure at the tip of SP-GRIPFLOW (if available) o Radial blood pressure, left and right (mmHg) • Circulatory arrest time (minutes) • Selective cerebral perfusion time (minutes) • Perfusion flow rate (mL/kg/min) (maximum and minimum) • Degree of hypothermia (degrees Celsius) (tympanic membrane or nasal temperature [for cerebral perfusion temperature measurement] and any of followings if available: rectal temperature, bladder temperature, or esophageal temperature [for systemic circulation temperature measurement]) | — |
Countries
Germany, Netherlands
Contacts
Public ContactT Sinnema
Avania B.V.
Outcome results
None listed