Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair

NCT05421130 | Unknown

• 1 other identifier: NL73323.100.21
• Study Type: interventional
• Target: 149
• Locations: 2 countries
• Sites: 5

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.

Conditions

Aortic Aneurysm; Aortic Dissection; Aortic Arch Aneurysm; Aortic Arch; Aneurysm, Dissecting

Outcome Measures

Primary Outcomes (1)

• "Successful perfusion" defined by flow rate through the catheter (mL/kg/min)

  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

  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 (1)

• "Adequate flow rate" assessed by a clinically relevant through the catheter(mean and maximum flow rate「mL/kg/min」). endpoints

  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 (8)

• The nature, severity and incidence of adverse events at 30-days post-procedure

  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.

• The collection of an intraoperative parameters(Number of catheter dislocations from target artery (Units))

  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.

• The collection of an intraoperative parameters(Near-infrared spectroscopy (O2 saturation))

  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.

Study Arms (1)

SP-GRIPFLOW

OTHER

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 investigational devices will be used per subject.

Device: Selective Cerebral Perfusion Catheter

Interventions

Selective Cerebral Perfusion Catheter DEVICE

This product is intended to be placed in the branches of the aortic arch for the cerebral perfusion during surgery of aorta.

Also known as: SP-GRIPFLOW

SP-GRIPFLOW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuji Systems Corporation: lead
• Avania: collaborator

Study Sites (5)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Campus Freiburg: Hugstetter Straße 55, 79106, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Theodor-Stern-Kai 7,, 60590, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Universitätsklinik Für Herzchirurgie Strümpellstraße 39, 04289, Germany

Location

St.Antonius Hospital

Nieuwegein, Koekoekslaan 1, 3435 CN, Netherlands

Location

Radboud universitair medisch centrum

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection; Aneurysm, Aortic Arch; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Aneurysm, Thoracic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: June 16, 2022
• Study Start: May 2, 2022
• Primary Completion: July 1, 2023
• Study Completion: February 1, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); DE (3)