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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (estimated)
• Sponsor: Fuji Systems Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-07-01
• Completion: 2024-02-01
• First posted: 2022-06-16
• Last updated: 2023-07-11

Locations

5 sites across 2 countries: Germany, Netherlands