PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France | NCT07748572

NCT07748572

Overview

NCT ID: NCT07748572
Lead Sponsor: Phenox GmbHINDUSTRY
Official Title: CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)
Brief Summary: 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.
Conditions: Intracranial Aneurysms
Interventions: Aneurysm treatment with a Flow Modulation Device

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Mar 7, 2025Actual
Primary Completion Date: Oct 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 200Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: Elisabeth Demant-BauchspiessContact
ceflow@wallabyphenox.com

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Participant Group/Arms

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 %).

Device: Aneurysm treatment with a Flow Modulation Device

Locations

CHU Amiens-PicardieRecruiting

Amiens, 80054, France

Cyril Chivot, Dr.Contact

CHU BordeauxRecruiting

Bordeaux, 33076, France

CHU Pierre WertheimerRecruiting

Bron, 69500, France

CHU Clermont-FerrandRecruiting

Clermont-Ferrand, 63003, France

Hôpital BicêtreRecruiting

Le Kremlin-Bicêtre, 94270, France

CHU de LimogesRecruiting

Limoges, 87042, France

Hôpital Pitié-SalpêtrièreRecruiting

Paris, 75651, France

CHU ReimsRecruiting

Reims, 51092, France

CHU RouenRecruiting

Rouen, 76031, France

CHRU StrasbourgRecruiting

Strasbourg, 67091, France

CHU ToursRecruiting

Tours, 37044, France

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