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 ]

Primary Outcome Measure is Modified Rankin Scale < or = to 2. Data will be analyzed on intent to treat basis with crossover to the alternative treatment analyzed as a data subset. The null hypothesis is that no difference in outcome will be detected between the endovascular and surgical treatment arms. A statistically significant difference will then be considered evidence in favor of the alternative hypothesis, that one treatment is superior to the other.


Original Primary Outcome: Statistically significant difference [ Time Frame: 6 years ]

Data will be analyzed on intent to treat basis with crossover to the alternative treatment analyzed as a data subset. The null hypothesis is that no difference in outcome will be detected between the endovascular and surgical treatment arms in any of the outcome measures. A statistically significant difference will then be considered evidence in favor of the alternative hypothesis, that one treatment is superior to the other.


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