Low-profile Visualized Intraluminal Support -HUD

NYU Langone Health

Status

Conditions: Giant Wide Necked Aneurysms

Treatments: Device: Low Profile Visualized Intraluminal Support Device

Study type: Expanded Access

Funder types: Other

Identifiers

NCT02695030

09-0222 (Other Identifier)

H130005 (Other Identifier)

14-01582

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.