Clinical trial NCT05421130: Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
Official title: Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Aneurysm
Aortic Dissection
Aortic Arch Aneurysm
Aortic Arch; Aneurysm, Dissecting
Lead sponsor: Fuji Systems Corporation
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-06-16
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 decide if the device should be approved for sale in the European Union. The SP-GRIPFLOW catheter may not yet be used by investigators outside of the study.

Through the study, FUJI will prove that the target flow as measured by the flow through the catheter(s)(cumulative flow for multiple catheters) was confirmed in 95% of cases.

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 the procedure as performed with current catheters. Furthermore, the SP-GRIPFLOW catheter is used in a similar manner as other catheters that are currently on the market. Contrary to available catheters, the SP-GRIPFLOW has a ribbed surface on the balloon end of the device, which aims to improve the grip of the balloon in order to reduce chances of dislocation from the target artery.

Clinical trials are needed to obtain or expand knowledge about the safety, suitability and effi-cacy of medical devices. This is why the legislative authority has specified in the law on medi-cal devices that new medical devices must be clinically tested. The clinical trial that we present to you here was - as required by law - granted a favourable opinion by an ethics committee and approved by the competent authority. This clinical trial will be conducted at up to 5 sites in the European Union; a total of approximately 149 persons will participate in it. The study is being initiated, organised, and financed by Fuji Systems Corporation, the sponsor of this study.

Eligibility 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 SPGRIPFLOW Catheter (12Fr, 14Fr or16Fr)

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

Primary outcomes:
measure: "Successful perfusion" defined by flow rate through the catheter (mL/kg/min)
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
Secondary outcomes:
measure: "Adequate flow rate" assessed by a clinically relevant through the catheter(mean and maximum flow rate「mL/kg/min」). endpoints
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
Other outcomes:
measure: The nature, severity and incidence of adverse events at 30-days post-procedure
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters(Number of catheter dislocations from target artery (Units))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters(Near-infrared spectroscopy (O2 saturation))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters (Perfusion pressure (mmHg))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters (Circulatory arrest time (minutes))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters (Selective cerebral perfusion time (minutes))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters(Perfusion flow rate (mL/kg/min) (maximum and minimum))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
measure: The collection of an intraoperative parameters(Degree of hypothermia (degrees Celsius))
timeFrame: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Campus Freiburg: Hugstetter Straße 55
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Theodor-Stern-Kai 7,
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Universitätsklinik Für Herzchirurgie Strümpellstraße 39
city: Nieuwegein
country: Netherlands
facility: St.Antonius Hospital
state: Koekoekslaan 1, 3435 CN
city: Nijmegen
country: Netherlands
facility: Radboud universitair medisch centrum
Study officials:
References: