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

Study acronym: LVIS PAS
StatusEnrolling by Invitation
PhaseNot specified
Started
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.

Record History

  1. Primary completion date: Oct 1, 2023 to Oct 1, 2025
    • Study completion date: Oct 1, 2023 to Jan 1, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05453240
Lead Sponsor Microvention-Terumo, Inc.
Conditions
(from sponsor)		 Intracranial Aneurysms
Related terms Intracranial Aneurysm
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov