Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02167997
Status:
UNKNOWN
Last Update Posted:
2016-08-18
First Post:
2014-06-17
Brief Title:
EffectiveNess and SAfety of Small ANeurysm COiling Trial
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
EffectiveNess and SAfety of Small ANeurysm COiling Trial
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
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:
NANO
Brief Summary:
To compare the safety and efficacy of treating small aneurysms with coils specially designed for small aneurysms to historically reported rates of safety and efficacy for the treatment of larger aneurysms
Detailed Description:
This is a prospective cohort study whereby patients who undergo endovascular treatment with coils for intracranial aneurysms will be studied for initial procedural and 12-18 month post-treatment outcome The procedural failure rate defined above of treating small aneurysms with specially designed coils will be compared to pre-specified historical occurrences This evaluation will occur within the framework of non-inferiority ie comparable success to coiling of large aneurysms
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