To confirm the longer-term safety and effectiveness of the LVIS Device. The aim of this study is to collect and provide FDA with longer term clinical performance of the LVIS device.
VIS PAS
Post-Approval Study- Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Brain aneurysm
All genders
18+
Recruiting now
Overview
Principal Investigator: Dr. Adel Malek
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Study details
Inclusion Criteria
- 1. Patients treated with the LVIS Device
- 2. Treatment of wide-necked intracranial saccular aneurysm arising from a parent vessel with diameter greater than or equal to 2.0mm and less than or equal to 4.5mm who underwent treatment with the LVIS device of researched sizes within the last 5 years
Exclusion Criteria
- Patients not treated according to the currently approved indications for use of the LVIS device
Study Requirements
This study includes retrospective data collection which does not alter nor dictate the standard of care the patient would have otherwise received.