Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01593267
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2012-04-30
Brief Title:
Barrow Ruptured Aneurysm Trial
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Barrow Ruptured Aneurysm Study
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_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:
BRAT
Brief Summary:
With evolving endovascular technologies there is a growing debate centered on the relative safety and efficacy of the currently accepted alternatives for the treatment of ruptured cerebral aneurysms in the face of acute subarachnoid hemorrhage SAH The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular coiling of acutely ruptured cerebral aneurysms in a prospective randomized fashion
Detailed Description:
The planned trial enrolled 250 subjects per arm Subjects are followed postoperatively and outcome endpoints will be assessed at Discharge 6 Months 1 Year 3 Years and 6 Years One hundred 100 subjects will participate in neuropsychological testing at 1 Year after the 100th subject an interim data analysis will be performed and the viability of future neuropsychological testing will be determined Subjects will receive preoperative intraoperative or postoperative 3 Year follow up and 6 Year follow up angiograms In this fashion immediate clinical outcome including peri-procedural morbidity and mortality will be assessed as will long term outcome both clinical and angiographic
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