Intracranial AneurysmsCEFloWNCT07748572
PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
An observational study of Intracranial Aneurysms, run by Phenox GmbH at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Aneurysm treatment with a Flow Modulation Device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 11 sitesFrance
- Study dates
- 7 Mar 2025to Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Cyril Chivot, Dr.
- Recruiting
CHU Bordeaux
Bordeaux, 33076
Xavier Barreau, Dr.
- Recruiting
CHU Pierre Wertheimer
Bron, 69500
Roberto Riva, Dr.
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Emmanuel Chabert, Prof.
- Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Laurent Spelle, Prof.
- Recruiting
CHU de Limoges
Limoges, 87042
Charbel Mounayer, Prof.
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75651
Frédéric Clarençon, Prof.
- Recruiting
CHU Reims
Reims, 51092
Laurent Pierot, Prof.
- Recruiting
CHU Rouen
Rouen, 76031
Nicolas Fonne, Dr.
- Recruiting
CHRU Strasbourg
Strasbourg, 67091
Raoul Pop, Dr.
- Recruiting
CHU Tours
Tours, 37044
Denis Herbreteau, Prof.
About this study
Official title: CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)
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
- Being tested
- Aneurysm treatment with a Flow Modulation Device
- Keywords
- Vascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Intracranial Aneurysm, Aneurysm
- Medical subject headings
- Intracranial Aneurysm, Vascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysm treatment with a Flow Modulation DeviceDevice
Treatment of an intracranial aneurysm (anterior and posterior circulation) with a p64, p48 MW, or p64 MW Flow Modulation Device.
| Study group | Role | What they receive |
|---|---|---|
| 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 %). Receives: Device: Aneurysm treatment with a Flow Modulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbi-Mortality Rate
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 ).
Measured: 12 Months
Secondary outcomes (6)
Percentage of Device deficiencies
Percentage of Device deficiencies up to 12 months post-procedure
Measured: 12 Months
Percentage of patients with intra-procedural complications
Percentage of patients with intra-procedural complications: Hemorrhagic complications, Thrombo-embolic complications, Other neurologic complications, Technical complications
Measured: During Procedure
Percentage of patients with post-procedural complications up to discharge
Percentage of patients with post-procedural complications up to discharge: Hemorrhagic complications, Thrombo-embolic complications, Neurologic complications
Measured: After Procedure up to Discharge (estimated at 72hrs after procedure)
Percentage of patients with post-discharge complications
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).
Measured: 12 Months
Percentage of patients with a complete occlusion of the target aneurysm
- 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)
Measured: 12 Months
Percentage of patients with a retreatment of the target aneurysm
Percentage of patients with a retreatment of the target aneurysm up to 12 months post-procedure
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start7 Mar 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Phenox GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Pierot, Prof., Principal investigator, CHU de ReimsLaurent Spelle, Prof., Principal investigator, Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748572
- Sponsor's protocol ID
- s1-CEFloW/ST-058
- Other IDs
- 19437707
- Acronym
- CEFloW
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)
- ClinicalTrials.gov ID
- NCT07748572
- Acronym / sponsor ID
- CEFloW / s1-CEFloW/ST-058
- Conditions
- Intracranial Aneurysms
- Keywords
- Vascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Intracranial Aneurysm, Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Phenox GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with intracranial aneurysms (anterior and posterior) treated with p64, p48 MW and p64 MW | – | Device: Aneurysm treatment with a Flow Modulation DeviceThe 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 %). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aneurysm treatment with a Flow Modulation DeviceTreatment of an intracranial aneurysm (anterior and posterior circulation) with a p64, p48 MW, or p64 MW Flow Modulation Device. | Device | Subjects with intracranial aneurysms (anterior and posterior) treated with p64, p48 MW and p64 MW |
Primary outcome
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 ).
6 secondary outcomes
Percentage of Device deficiencies
Time frame: 12 Months
Percentage of patients with intra-procedural complications
Time frame: During Procedure
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-discharge complications
Time frame: 12 Months
Percentage of patients with a complete occlusion of the target aneurysm
Time frame: 12 Months
Percentage of patients with a retreatment of the target aneurysm
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Pierot, Prof. principal investigator
CHU de Reims
Laurent Spelle, Prof. principal investigator
Hôpital Bicêtre
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Phenox GmbH at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Demant-Bauchspiess (+49 (0) 173 3099117, ceflow@wallabyphenox.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbi-Mortality Rate (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.