NCT01593267

Barrow Ruptured Aneurysm Trial

Barrow Ruptured Aneurysm Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ruptured Cerebral Aneurysm
• Subarachnoid Hemorrhage (SAH)

Interventions

Type	Name	Description
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.
PROCEDURE	clip occlusion	Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.

Timeline

• Start date: 2002-11-01
• Primary completion: 2019-10-25
• Completion: 2023-12-31
• First posted: 2012-05-08
• Last updated: 2021-09-21

Locations

1 site across 1 country: United States