Barrow Ruptured Aneurysm Trial (BRAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01593267|
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ruptured Cerebral Aneurysm Subarachnoid Hemorrhage (SAH)||Procedure: coil embolization Procedure: clip occlusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Barrow Ruptured Aneurysm Study|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||October 25, 2019|
|Actual Study Completion Date :||October 25, 2019|
Active Comparator: Endovascular
Subjects randomized to endovascular coil embolization will be treated by one of two neurosurgeons expert in such treatment. All endovascular coil embolization treatments will be accomplished using accepted techniques.
Procedure: coil embolization
Subjects randomized to endovascular therapy will be treated by one of two neurosurgeons expert in such treatment. All endovascular treatments will be accomplished using accepted techniques.
Active Comparator: Surgical
Subjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms.
Procedure: clip occlusion
Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.
- Modified Rankin Scale [ Time Frame: 10 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593267
|United States, Arizona|
|St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Robert F Spetzler, MD||Barrow Brain and Spine|