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

NCT05453240 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-06-17

No results posted yet for this study

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

  • Intracranial Aneurysms

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2025-10-01
Completion
2026-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453240 on ClinicalTrials.gov