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

January 22, 2024 updated by: Microvention-Terumo, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Pellgrin
      • Caen, France
        • CHU Caen
      • Clermont-Ferrand, France
        • CHU Gabriel Montpied
      • Grenoble, France
        • CHU Michallon
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
      • Limoges, France
        • Chu Limoges
      • Marseille, France
        • Hôpital Clairval
      • Marseille, France
        • Hôpital de la Timone
      • Montpellier, France
        • Hopital Gui de Chauliac
      • Nancy, France
        • Hôpital Central de Nancy
      • Nice, France
        • Hopital Pasteur 2
      • Paris, France
        • Hôpital Pitié-Salpêtrière
      • Paris, France
        • Hopital Lariboisiere
      • Paris, France
        • La Fondation Rothschild
      • Reims, France
        • Hôpital Maison Blanche
      • Saint-Étienne, France
        • Hopital Nord
      • Suresnes, France
        • Hopital Foch
      • Toulon, France
        • Hôpital d'instruction des Armées Saint-Anne
      • Toulouse, France
        • Hopital Purpan
      • Tours, France
        • Hôpital Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent

Description

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 Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: 1 year
1 year
Morbidity Rate
Time Frame: 1 year
Number of adverse events with clinical impact related to the procedure and/or the device
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effectiveness
Time Frame: 1 year
Number of patients with mRS>2
1 year
Anatomical effectiveness
Time Frame: 1 year
Number of patients with complete occlusion of the treated aneurysm
1 year
Retreatment rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Collaborators

Clinact

Investigators

  • Principal Investigator: Michel Piotin, MD, Fondation Rothschild, Paris, France
  • Principal Investigator: Charbel Mounayer, Prof., CHU de Limoges, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2018

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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