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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 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Fuji Systems Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2023-07-01
Completion
2024-02-01

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421130 on ClinicalTrials.gov