Trials / Enrolling By Invitation
Enrolling By InvitationNCT05453240
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2020-11-17
- Primary completion
- 2025-10-01
- Completion
- 2026-01-01
- First posted
- 2022-07-12
- Last updated
- 2025-06-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05453240. Inclusion in this directory is not an endorsement.