Intracranial Aneurysm
Conditions
Keywords
aneurysm, endovascular
Brief summary
A French, multicenter, prospective, observational, real life assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms
Detailed description
This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to collect data on safety of the devices used since the French reimbursement. 130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.
Interventions
DEVICELVIS and LVIS JR
Braided coil assist stents used for aneurysm embolization
Sponsors
Clinact
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 LVIS or LVIS JR, either scheduled or emergency ( Bail-out stenting ) * 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 | — |
| Morbidity Rate | 1 year | Number of adverse events with clinical impact related to the procedure and/or the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effectiveness | 1 year | Number of patients with mRS\>2 |
| Anatomical effectiveness | 1 year | Number of patients with complete occlusion of the treated aneurysm |
| Retreatment rate | 1 year | — |
Countries
France
Outcome results
None listed