Registry of flow diverter devices for brain aneurysms in France
Follows how flow diverter devices work in adults with brain aneurysms.
Key facts
- Who runs it
- Phenox GmbH
- Where
- Amiens, Bordeaux, Bron, Clermont-Ferrand, Le Kremlin-Bicêtre, Limoges, Paris, Reims, Rouen, Strasbourg, and Tours, FranceSee the 11 sites
- Trial code
- Registry title
- PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 7 Mar 2025
- Expected to end
- Dec 2028
- Type of study
- Observational
- Treatments tested
- Aneurysm treatment with a Flow Modulation Device
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in France with a bulge in a brain blood vessel (intracranial aneurysm). They must be treated, or planned to be treated, with the p64, p48 MW or p64 MW flow diverter device.
- Age
- 18 years or older, and legally an adult.
- Sex
- All sexes can join.
- Disease stage
- One or more intracranial aneurysms, in the front or back of the brain. Burst (ruptured) aneurysms can be included if treated in planned steps or if no other technique can treat them.
Main reasons for not taking part
- Taking part in another study that changes standard patient care (for example the COATING study).
- Any state or circumstance that stops the person from having the site's usual follow-up after aneurysm treatment.
- The person or their legal representative objects to the collection and use of their data.
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in France
- Chu Amiens PicardieAmiens, FranceContact: Cyril Chivot, Dr.Taking people
- CHU BordeauxBordeaux, FranceContact: Xavier Barreau, Dr.Taking people
- CHU Pierre WertheimerBron, FranceContact: Roberto Riva, Dr.Taking people
- CHU Clermont-FerrandClermont-Ferrand, FranceContact: Emmanuel Chabert, Prof.Taking people
- Hopital BicetreLe Kremlin-Bicêtre, FranceContact: Laurent Spelle, Prof.Taking people
- CHU de LimogesLimoges, FranceContact: Charbel Mounayer, Prof.Taking people
- Hopital Pitie-SalpetriereParis, FranceContact: Frédéric Clarençon, Prof.Taking people
- CHU ReimsReims, FranceContact: Laurent Pierot, Prof.Taking people
- CHU RouenRouen, FranceContact: Nicolas Fonne, Dr.Taking people
- CHRU StrasbourgStrasbourg, FranceContact: Raoul Pop, Dr.Taking people
- CHU ToursTours, FranceContact: Denis Herbreteau, Prof.Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Subjects with intracranial aneurysms (anterior and posterior) treated with p64, p48 MW and p64 MW
The registry will include subjects across France who are treated for an intracranial aneurysm with a p64, p64 MW or p48 MW Flow Modulation Device. In total, it is anticipated to include approximatively 200 subjects over the inclusion period: 160 subjects treated with p64 /p64 MW (80 %) and 40 subjects treated with p48 MW (20 %).
Treatment: Aneurysm treatment with a Flow Modulation Device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)
- Plain-language title
- Registry of flow diverter devices for brain aneurysms in FranceGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 5 August 2026