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PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France

Key facts

Who runs it
Phenox GmbH
Where
France11 sites in 1 countryChoose a country to see its sites
Trial code
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

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)
Record updated
5 August 2026