Low-profile Visualized Intraluminal Support -HUD

NCT ID: NCT02695030

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Giant Wide Necked Aneurysms

Interventions

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Low Profile Visualized Intraluminal Support Device

LVIS device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck, intracranial, saccular aneurysms.

Intervention Type DEVICE

Other Intervention Names

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Intracranial Stent

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Riina, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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09-0222

Identifier Type: OTHER

Identifier Source: secondary_id

H130005

Identifier Type: OTHER

Identifier Source: secondary_id

14-01582

Identifier Type: -

Identifier Source: org_study_id

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