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

Recruitingn/aAges 18 Years - anyAllPhenox GmbH
NCT07748572 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Aneurysm treatment with a Flow Modulation Device
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Where

11 sites
CHU Amiens-Picardie
Amiens, France
CHU Bordeaux
Bordeaux, France
CHU Pierre Wertheimer
Bron, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU de Limoges
Limoges, France
Hôpital Pitié-Salpêtrière
Paris, France
CHU Reims
Reims, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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