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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
NA trial testing Selective Cerebral Perfusion Catheter in Aortic Aneurysm in 149 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | Fuji Systems Corporation |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 149 |
| Start date | 2 May 2022 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 February 2024 |
| Sites | 5 locations across Netherlands, Germany |
Drugs / interventions tested
- Selective Cerebral Perfusion Catheter
Conditions studied
- Aortic Aneurysm — all drugs for Aortic Aneurysm →
- Aortic Dissection — all drugs for Aortic Dissection →
- Aortic Arch Aneurysm — all drugs for Aortic Arch Aneurysm →
- Aortic Arch; Aneurysm, Dissecting — all drugs for Aortic Arch; Aneurysm, Dissecting →
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.
Verify or expand the search:
- PubMed search for NCT05421130
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05421130 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fuji Systems Corporation
- Last refreshed: 11 July 2023
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