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

ConditionIntracranial Aneurysms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPhenox GmbH

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

The registry will include subjects across France who are treated for an intracranial aneurysm with a p64, p64 MW or p48 MW Flow Modulation Device.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Aneurysm treatment with a Flow Modulation Device

    Device

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Subjects with intracranial aneurysms (anterior and posterior) treated with p64, p48 MW and p64 MW1 intervention

Trial outcomes

Primary outcomes

1

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

1

Percentage of Device deficiencies

Percentage of Device deficiencies up to 12 months post-procedure

Time frame
12 Months
2

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
3

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)
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phenox GmbH

Lead sponsor

Source ClinicalTrials.gov
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