Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT01793792
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2013-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Sponsor:
Microvention-Terumo, Inc.
Organization:
Study Overview
Official Title:
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
Status:
COMPLETED
Status Verified Date:
2019-11
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:
LVIS
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| G110188/S004 | OTHER | FDA | View |