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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 NA Last updated 11 July 2023
What this trial tests

NA trial testing Selective Cerebral Perfusion Catheter in Aortic Aneurysm in 149 participants. Status unknown.

Timeline
2 May 2022
Primary endpoint
1 July 2023
1 February 2024

Quick facts

Lead sponsorFuji Systems Corporation
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment149
Start date2 May 2022
Primary completion1 July 2023
Estimated completion1 February 2024
Sites5 locations across Netherlands, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Fuji Systems Corporation

Who can join

18 and older, any sex, with Aortic Aneurysm or Aortic Dissection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Aortic Aneurysm

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05421130.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing