Clinical Trial

Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device

Study acronym: LVIS PAS
Enrolling by Invitation
View on ClinicalTrials.gov →
Record status
This record was last updated June 17, 2025 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-07-06.
Trial Details
NCT Number NCT05453240
Lead Sponsor Microvention-Terumo, Inc.
Conditions Intracranial Aneurysms
Enrollment 250 participants
Start Date 2020-11-17
Primary Completion 2025-10-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-17