Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01762137
Status:
TERMINATED
Last Update Posted:
2018-02-13
First Post:
2012-11-16
Brief Title:
LARGE Aneurysm Randomized Trial Flow Diversion Versus Traditional Endovascular Coiling Therapy
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
LARGE Aneurysm Randomized Trial Flow Diversion Versus Traditional Endovascular Coiling Therapy
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Rarity of disease and current practice in the field made enrollment challenging
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LARGE
Brief Summary:
In this study patients with large anterior circulation IAs with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion will be randomly assigned to either treatment technique
Detailed Description:
This is a prospective randomized trial comparing the endovascular coiling endovascular coiling versus the flow diversion for large and giant aneurysm treatment The endovascular coiling used in this study are FDA-approved and in common use at institutions in this country and across the world The flow diversion devices are FDA-approved for anterior circulation aneurysms 10 mm and are in common use at institutions in this country and across the world Patients will be enrolled who meet the inclusion criteria and consent to participate Patients will be randomly assigned by a central web-based system in a 11 manner to treatment with either endovascular coiling or flow diversion Data on each patient will be collected at the time of enrollment and treatment and at subsequent follow-up visits
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