Clinical Trial: Barrow Ruptured Aneurysm Trial
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Barrow Ruptured Aneurysm Study
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 Summary: 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.
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Current Primary Outcome: Modified Rankin Scale [ Time Frame: 6 years ]
Original Primary Outcome: Statistically significant difference [ Time Frame: 6 years ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St. Joseph's Hospital and Medical Center, Phoenix
Dates:
Date Received: April 30, 2012
Date Started: November 2002
Date Completion: July 2017
Last Updated: May 19, 2017
Last Verified: May 2017