NCT03553771CompletedNot Applicable
A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms
Microvention-Terumo, Inc.20 sites in 1 country130 target enrollmentStarted: February 7, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 20
- Primary Endpoint
- Morbidity Rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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
- Not provided
Outcomes
Primary Outcomes
Morbidity Rate
Time Frame: 1 year
Number of adverse events with clinical impact related to the procedure and/or the device
Mortality Rate
Time Frame: 1 year
Secondary Outcomes
- Clinical effectiveness(1 year)
- Anatomical effectiveness(1 year)
- Retreatment rate(1 year)
Investigators
Study Sites (20)
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