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NCT Number: NCT07748572

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

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.

Recruiting

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Key information

Conditions

Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aneurysm treatment with a Flow Modulation Device

Device

Treatment of an intracranial aneurysm (anterior and posterior circulation) with a p64, p48 MW, or p64 MW Flow Modulation Device.

Primary outcomes

  1. Morbi-Mortality Rate

    Time frame: 12 Months

    The morbi-mortality rate related to procedure/device at 12 months post-procedure defined by an mRS ≥ 3 in subjects with an mRS less than or equal to 2 prior to the procedure or a 1-point increase over the initial mRS score in subjects with an mRS above 2 prior to the procedure (in the case of ruptured aneurysms, a pre-rupture reconstituted mRS will be collected ).

Secondary outcomes

  1. Percentage of Device deficiencies

    Time frame: 12 Months

    Percentage of Device deficiencies up to 12 months post-procedure

  2. Percentage of patients with intra-procedural complications

    Time frame: During Procedure

    Percentage of patients with intra-procedural complications: Hemorrhagic complications, Thrombo-embolic complications, Other neurologic complications, Technical complications

  3. Percentage of patients with post-procedural complications up to discharge

    Time frame: After Procedure up to Discharge (estimated at 72hrs after procedure)

    Percentage of patients with post-procedural complications up to discharge: Hemorrhagic complications, Thrombo-embolic complications, Neurologic complications

  4. Percentage of patients with post-discharge complications

    Time frame: 12 Months

    Percentage of patients with post-discharge complications: Stroke in the 1st month post-procedure, Major stroke 12 months post-procedure (+4 points NIHSS) in the territory of the treated aneurysm (PUFS).

  5. Percentage of patients with a complete occlusion of the target aneurysm

    Time frame: 12 Months

    • Percentage of patients with a complete occlusion of the target aneurysm at 12 months post-procedure (Raymond-Roy Occlusion Classification (RROC): class I: complete obliteration, class II: residual neck, class III: residual aneurysm)

  6. Percentage of patients with a retreatment of the target aneurysm

    Time frame: 12 Months

    Percentage of patients with a retreatment of the target aneurysm up to 12 months post-procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Demant-Bauchspiess

CONTACT

[email protected]

+49 (0) 173 3099117

Meike Arnold

CONTACT

[email protected]

+49 (0) 234 36 919 2530

Sponsors and collaborators

Lead sponsor

Phenox GmbH

Industry

Registry information

Official study title

CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)

Acronym: CEFloW

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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