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

NCT ID: NCT05421130

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2024-02-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SP-GRIPFLOW

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.

Group Type: OTHER

Selective Cerebral Perfusion Catheter

Intervention Type: DEVICE

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

Interventions

Selective Cerebral Perfusion Catheter

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

Intervention Type: DEVICE

Other Intervention Names

SP-GRIPFLOW

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

Fuji Systems Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Freiburg

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

Universitätsklinikum Frankfurt

Frankfurt, Theodor-Stern-Kai 7,, Germany

Herzzentrum Leipzig GmbH

Leipzig, Universitätsklinik Für Herzchirurgie Strümpellstraße 39, Germany

St.Antonius Hospital

Nieuwegein, Koekoekslaan 1, 3435 CN, Netherlands

Radboud universitair medisch centrum

Nijmegen, , Netherlands

Countries

Germany; Netherlands

Other Identifiers

NL73323.100.21

Identifier Type: -

Identifier Source: org_study_id