Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms

Microvention-Terumo, Inc.130 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Intracranial Aneurysm

Interventions

LVIS and LVIS JRDEVICE

Braided coil assist stents used for aneurysm embolization

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 Exclusion Criteria: * None

Locations (20)

CHU Pellgrin

Bordeaux, France

CHU Caen

Caen, France

CHU Gabriel Montpied

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Mortality Rate

Time frame: 1 year

Morbidity Rate

Number of adverse events with clinical impact related to the procedure and/or the device

Time frame: 1 year

Secondary Outcomes

Clinical effectiveness

Number of patients with mRS\>2

Time frame: 1 year

Anatomical effectiveness

Number of patients with complete occlusion of the treated aneurysm

Time frame: 1 year

Retreatment rate

Time frame: 1 year

Data from ClinicalTrials.gov

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