Flow Diverter Registry: Safety and Performance of p64, p64 MW, and p48MW in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects data on adults with intracranial aneurysms treated with phenox Flow Diverters (p64, p64 MW, p48MW) across participating French sites. Hospitals record safety outcomes and device performance as part of standard care, following local treatment guidelines. The study aims to describe real-world use and outcomes in both anterior and posterior circulation aneurysms. Enrollment is limited to patients who are treated or planned to be treated with the specified devices, with data collected under routine follow-up. The registry is sponsored by Phenox GmbH and involves multiple centers in France to capture a broad clinical experience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• CHU Amiens-Picardie
  Amiens, France Recruiting
• CHU Bordeaux
  Bordeaux, France Recruiting
• CHU Pierre Wertheimer
  Bron, France Recruiting
• CHU Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Recruiting
• CHU de Limoges
  Limoges, France Recruiting

Study contacts

• Principal investigator: Laurent Pierot, Prof. — CHU de Reims
• Study coordinator: Elisabeth Demant-Bauchspiess
• Email: ceflow@wallabyphenox.com
• Phone: +49 (0) 173 3099117

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.