Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02695030
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-03-26
First Post:
2016-02-24
Brief Title:
Low-profile Visualized Intraluminal Support -HUD
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
MicroVention Low-profile Visualized Intraluminal Support LVIS or LVIS Jr Humanitarian Use Device LVIS HUD
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25mm and less than or equal to 45mm
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H130005 | OTHER | Humanitarian Device Exemption Number | None |
| 09-0222 | OTHER | None | None |