An observational study in Intracranial Aneurysms, sponsored by Phenox GmbH. Recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Phenox GmbH · Observational
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.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Phenox GmbH is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Treatment of an intracranial aneurysm (anterior and posterior circulation) with a p64, p48 MW, or p64 MW Flow Modulation Device.
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 ).
Time frame: 12 Months
Percentage of Device deficiencies
Percentage of Device deficiencies up to 12 months post-procedure
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 12 Months
Percentage of patients with a complete occlusion of the target aneurysm
1\. 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)
Time frame: 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
Time frame: 12 Months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Oct 2028, 43 months after the start.
Of 104 observational studies under Intracranial Aneurysm, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 145. This study's planned 43 months is close to that.
How these figures are worked out, and which studies are left out of them.
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