PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
Recruiting now
Conditions studied: Intracranial Aneurysms
In brief
To evaluate safety and performance of the phenox GmbH Flow Diverter p64, p64 MW, and p48MW in France, this registry will include subjects with intracranial aneurysms (anterior and posterior) who are treated with a phenox GmbH Flow Diverter. The subjects will be treated according to the standard of care in the participating sites.
Key facts
- Study ID
- NCT07748572
- Run by
- Phenox GmbH
- People needed
- 200
- Starts
- 2025-03-07
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1. Age ≥ 18 years and legally of age.
- 2. The patient has intracranial aneurysm(s) * and is treated or planned to be treated with p64, p48 MW or p64 MW Devices. (*cases of ruptured aneurysms in the context of a staged procedure or not treatable by another technique, and cases of multiple aneurysms are eligible)
- 3. The patient or his/her legal representative (in case the patient does not have the capacity due to his/her clinical condition), does not object to the collection and processing of the data specified in the protocol.
You may not qualify if…
- 1. Participation in an interventional study modifying standard patient care management (e.g. COATING study)
- 2. State or circumstance that does not allow the patient to undergo the standard site's follow-up for aneurysm treatment
Where it is running
- CHU Amiens-Picardie — Amiens, France (enrolling)
- CHU Bordeaux — Bordeaux, France (enrolling)
- CHU Pierre Wertheimer — Bron, France (enrolling)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
- CHU de Limoges — Limoges, France (enrolling)
- Hôpital Pitié-Salpêtrière — Paris, France (enrolling)
- CHU Reims — Reims, France (enrolling)
- CHU Rouen — Rouen, France (enrolling)
- CHRU Strasbourg — Strasbourg, France (enrolling)
- CHU Tours — Tours, France (enrolling)
Full record on ClinicalTrials.gov
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