Overview

This trial is active, not recruiting.

Conditions ruptured cerebral aneurysm, subarachnoid hemorrhage (sah)
Treatments coil embolization, clip occlusion
Sponsor St. Joseph's Hospital and Medical Center, Phoenix
Collaborator Barrow Neurological Foundation
Start date November 2002
End date January 2017
Trial size 500 participants
Trial identifier NCT01593267, 02BN090

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
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)
Subjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms.
clip occlusion
Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.

Primary Outcomes

Measure
Modified Rankin Scale
time frame: 6 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Acute subarachnoid hemorrhage (SAH) - Confirmed by CT scan or lumbar puncture - Age 18-80 years - Ability to give informed consent (subject or legally authorized representative) - No anatomic inclusions Exclusion Criteria: - Traumatic subarachnoid hemorrhage - Presents to hospital >14 days post-bleed - SAH caused by other primary disease - No anatomic exclusions

Additional Information

Official title Barrow Ruptured Aneurysm Study
Principal investigator Robert F Spetzler, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix.