Intracranial Aneurysms
Conditions
Keywords
Vascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Intracranial Aneurysm, Aneurysm
Brief 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.
Interventions
DEVICEAneurysm treatment with a Flow Modulation Device
Treatment of an intracranial aneurysm (anterior and posterior circulation) with a p64, p48 MW, or p64 MW Flow Modulation Device.
Sponsors
Phenox GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbi-Mortality Rate | 12 Months | 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 ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Device deficiencies | 12 Months | Percentage of Device deficiencies up to 12 months post-procedure |
| Percentage of patients with intra-procedural complications | During Procedure | Percentage of patients with intra-procedural complications: Hemorrhagic complications, Thrombo-embolic complications, Other neurologic complications, Technical complications |
| Percentage of patients with post-procedural complications up to discharge | After Procedure up to Discharge (estimated at 72hrs after procedure) | Percentage of patients with post-procedural complications up to discharge: Hemorrhagic complications, Thrombo-embolic complications, Neurologic complications |
| Percentage of patients with post-discharge complications | 12 Months | 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). |
| Percentage of patients with a complete occlusion of the target aneurysm | 12 Months | 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) |
| Percentage of patients with a retreatment of the target aneurysm | 12 Months | Percentage of patients with a retreatment of the target aneurysm up to 12 months post-procedure |
Countries
France
Contacts
CONTACTElisabeth Demant-Bauchspiess
CONTACTMeike Arnold
PRINCIPAL_INVESTIGATORLaurent Pierot, Prof.
CHU de Reims
PRINCIPAL_INVESTIGATORLaurent Spelle, Prof.
Hôpital Bicêtre
Outcome results
None listed