Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Aneurysm+6

+ Brain Diseases

+ Cardiovascular Diseases

+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2018
See protocol details

Summary

Principal SponsorMicrovention-Terumo, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 7, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT03553771
Principal SponsorMicrovention-Terumo, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AneurysmBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesIntracranial AneurysmCerebrovascular DisordersNervous System DiseasesVascular DiseasesIntracranial Arterial Diseases

Criteria

2 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Suspended

La Fondation Rothschild

Paris, FranceOpen La Fondation Rothschild in Google Maps
Suspended

Hôpital Maison Blanche

Reims, France
Suspended

Hôpital Nord

Saint-Etienne, France
Suspended

CHU Pellgrin

Bordeaux, France
Completed20 Study Centers