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

Intracranial Aneurysms Clinical Trial

Official title:
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05453240
Study type Observational
Source Microvention-Terumo, Inc.
Contact
Status Enrolling by invitation
Phase
Start date November 17, 2020
Completion date October 1, 2023
View Details
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