Low-profile Visualized Intraluminal Support -HUD

March 22, 2019 updated by: NYU Langone Health

MicroVention Low-profile Visualized Intraluminal Support (LVIS*) or LVIS Jr Humanitarian Use Device (LVIS HUD)

The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

Wide neck aneurysms are very difficult to treat both surgically and endovascularly with clipping or coiling. The availability of this neurovascular flow diverter as a Humanitarian Use Device has provided an additional approach to aneurysm occlusion using endovascular techniques.

Study Type

Expanded Access

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

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two),Intracranial, saccular aneurysm arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm.

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?

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Howard Riina, MD, New York University Medical School

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 Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 22, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-01582
  • 09-0222 (Other Identifier: Humanitarian Use Device Designation Number)
  • H130005 (Other Identifier: Humanitarian Device Exemption Number)

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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