A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms

Microvention-Terumo, Inc.20 sites in 1 country130 target enrollmentFebruary 7, 2018

ConditionsIntracranial Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Aneurysm
Sponsor: Microvention-Terumo, Inc.
Enrollment: 130
Locations: 20
Primary Endpoint: Morbidity Rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms

Detailed Description

This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to collect data on safety of the devices used since the French reimbursement. 130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.

Registry

clinicaltrials.gov

Start Date

February 7, 2018

End Date

July 1, 2021

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Microvention-Terumo, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency (" Bail-out stenting ")
•Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data