Barrow Ruptured Aneurysm Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | November 2002 |
| End Date: | March 2017 |
Barrow Ruptured Aneurysm Study
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.
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.
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.
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.
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
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St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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