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Recruiting NCT07748572

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

Conditions: Intracranial Aneurysms

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Phenox GmbH

Location: CHU Amiens-Picardie Amiens

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07748572). StuddyBuddy aggregates publicly available trial information.