PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
Recruiting
Observational Study
Intracranial Aneurysms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Phenox GmbH · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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 c…
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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