MedPath

Low-profile Visualized Intraluminal Support -HUD

Conditions
Giant Wide Necked Aneurysms
Registration Number
NCT02695030
Lead Sponsor
NYU Langone Health
Brief Summary

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

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.

Recruitment & Eligibility

Status
APPROVED_FOR_MARKETING
Sex
All
Target Recruitment
Not specified
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.
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Exclusion Criteria

Not provided

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Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York University School of Medicine

🇺🇸

New York, New York, United States

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