Intracranial Aneurysm
Conditions
Keywords
aneurysm, endovascular, flow-diverter
Brief summary
A French, multicenter, prospective, observational, real-world assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms
Detailed description
Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care. Sample Size: 138 patients.
Interventions
DEVICEFRED and FRED JR
Intracranial aneurysm treatment
Sponsors
Microvention-Terumo, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR * Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | 1 year | Percentage of patients with neurological death |
| Morbidity Rate | 1 year | Percentage of patients with major ipsilateral stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Score | 1 year | worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death) |
| Complete aneurysm occlusion rate | 1 year | Measured by the Raymond Scale |
| Retreatment Rate | 1 year | Rate and description of aneurysm retreated or planned for retreatment |
| Patient description | 1 year | Description of the population of patients treated with FRED and FRED JR in France |
Countries
France
Outcome results
None listed