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NCT02695030 Clinical Trial

Low-profile Visualized Intraluminal Support -HUD

Giant Wide Necked Aneurysms Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT02695030
Other study ID # 14-01582
Secondary ID 09-0222H130005
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date March 2019
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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 information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States,