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

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT03553771
• Lead Sponsor: Microvention-Terumo, Inc.

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.

Study Timeline

• Study Start: 2018-02-07
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity Rate	1 year	Number of adverse events with clinical impact related to the procedure and/or the device
Mortality Rate	1 year

Secondary Outcome Measures

Name	Time	Method
Clinical effectiveness	1 year	Number of patients with mRS\>2
Anatomical effectiveness	1 year	Number of patients with complete occlusion of the treated aneurysm
Retreatment rate	1 year

Trial Locations

Locations (20)

Hôpital Central de Nancy; 🇫🇷 Nancy, France

CHU Pellgrin; 🇫🇷 Bordeaux, France

CHU Caen; 🇫🇷 Caen, France

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

CHU Michallon; 🇫🇷 Grenoble, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

CHU Limoges; 🇫🇷 Limoges, France

Hôpital Clairval; 🇫🇷 Marseille, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Pasteur 2; 🇫🇷 Nice, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

La Fondation Rothschild; 🇫🇷 Paris, France

Hôpital Maison Blanche; 🇫🇷 Reims, France

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Nord; 🇫🇷 Saint-Étienne, France

Hôpital d'instruction des Armées Saint-Anne; 🇫🇷 Toulon, France

Hôpital Purpan; 🇫🇷 Toulouse, France

Hôpital Bretonneau; 🇫🇷 Tours, France