Clinical Trials in France / NCT07748572
Recruiting
Observational
PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
NCT07748572 · tracked via the Priya Life Science France tracker
Condition(s) studied
Intracranial Aneurysms
Investigational drug(s) / intervention(s)
Aneurysm treatment with a Flow Modulation 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.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Morbi-Mortality Rate — 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 ).
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Amiens-Picardie | Amiens | France | Recruiting |
| CHU Bordeaux | Bordeaux | France | Recruiting |
| CHU Pierre Wertheimer | Bron | France | Recruiting |
| CHU Clermont-Ferrand | Clermont-Ferrand | France | Recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Recruiting |
| CHU de Limoges | Limoges | France | Recruiting |
| Hôpital Pitié-Salpêtrière | Paris | France | Recruiting |
| CHU Reims | Reims | France | Recruiting |
| CHU Rouen | Rouen | France | Recruiting |
| CHRU Strasbourg | Strasbourg | France | Recruiting |
| CHU Tours | Tours | France | Recruiting |
More Phenox GmbH trials in France
Other trials for the same condition
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
Active, not recruiting
Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN
Active, not recruiting
Risk Analysis of Intracranial Aneurysm Rupture Through Social Determinants of Health
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07748572 on ClinicalTrials.gov ↗ ← All trials in France