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NCT03553771 Clinical Trial

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

Intracranial Aneurysm Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03553771
Other study ID # LEPI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 7, 2018
Est. completion date July 1, 2021

Study information
Verified date January 2024
Source Microvention-Terumo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• LVIS and LVIS JR
Braided coil assist stents used for aneurysm embolization

Locations
Country Name City State
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 Central de Nancy Nancy
France Hôpital Pasteur 2 Nice
France Hôpital Lariboisière Paris
France Hôpital Pitié-Salpêtrière Paris
France La Fondation Rothschild Paris
France Hôpital Maison Blanche Reims
France Hôpital Nord Saint-Étienne
France Hôpital Foch Suresnes
France Hôpital d'instruction des Armées Saint-Anne Toulon
France Hôpital Purpan Toulouse
France Hôpital Bretonneau Tours

Sponsors (2)
Lead Sponsor Collaborator
Microvention-Terumo, Inc. Clinact

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Rate 1 year
Primary Morbidity Rate Number of adverse events with clinical impact related to the procedure and/or the device 1 year
Secondary Clinical effectiveness Number of patients with mRS>2 1 year
Secondary Anatomical effectiveness Number of patients with complete occlusion of the treated aneurysm 1 year
Secondary Retreatment rate 1 year
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