Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01541254
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2012-02-15
Brief Title:
Feasibility Study of the LVIS Low-profile Visualized Intraluminal SupportDevice
Sponsor:
Microvention-Terumo Inc
Organization:
Microvention-Terumo Inc
Study Overview
Official Title:
A Feasibility Study of the MicroVentionIncLVIS Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms
Status:
COMPLETED
Status Verified Date:
2014-09
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 probable benefit of the Low-profile Visualized Intraluminal Support LVIS and LVIS Jrdevices from MicroVention Inc when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils
Detailed Description:
With the stent-assisted technique to treat wide neck intracranial aneurysms the neurovascular stent is placed across the aneurysm neck to act as a bridge to prevent coils from protruding into the parent artery Stenting may allow to more safely achieve a higher packing density of coils These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatmentThe LVIS device manufactured by MicroVention Inc has a braided design which may provide superior conformability and parent artery apposition as well as a more reliable continuous and uniform neck bridging than other neurovascular stents
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