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

Phenox GmbH200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Intracranial Aneurysms

Interventions

Aneurysm treatment with a Flow Modulation DeviceDEVICE

Treatment of an intracranial aneurysm (anterior and posterior circulation) with a p64, p48 MW, or p64 MW Flow Modulation Device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

CHU Amiens-Picardie

Amiens, France

RECRUITING

CHU Bordeaux

Bordeaux, France

RECRUITING

CHU Pierre Wertheimer

Bron, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Central Contacts

Elisabeth Demant-Bauchspiess

CONTACT

+49 (0) 173 3099117 ceflow@wallabyphenox.com

Meike Arnold

CONTACT

+49 (0) 234 36 919 2530 ceflow@wallabyphenox.com

Data from ClinicalTrials.gov

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