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Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Sponsor: Microvention-Terumo, Inc.
Summary
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.
Official title: Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2020-11-17
Completion Date
2026-01-01
Last Updated
2025-06-17
Healthy Volunteers
No
Conditions
Locations (1)
Microvention
Aliso Viejo, California, United States