A randomized multicenter clinical trial of unruptured brain AVMs (ARUBA)
The ARUBA study is a clinical trial to find out better ways of caring for people who have been discovered to have an arteriovenous malformation (AVM) in the brain that has never bled.
Subjects interested in the ARUBA trial will be randomized into one of two groups: those who undergo AVM elimination and those who will not. Subjects assigned to the AVM elimination group will receive interventional therapy, either surgery, radiation therapy, or some combination of treatments, chosen by their doctor. Subjects assigned to medical management will receive medications and the same amount of regular follow-up visits with your assigned neurologist.
Enrolled patients will be followed for between five and 7.5 years. Enrolled patients are seen every six months for the first two years, and at least every year after that until the end of the study.
The primary objective is to determine if medical management improves long-term outcomes of patients with unruptured brain arteriovenous malformations (AVMs) compared to invasive treatment (with endovascular procedures, neurosurgery or radiotherapy, alone or in combination).
The trial plans to enroll patients from close to 100 different institutions in North America, Europe, Australia and South America. Rush University Medical Center plans to enroll 30 patients.
You may be eligible to participate in this study if you:
- Have an unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- Are 18 years of age or older
You will be excluded from this study if you:
- Have a BAVM presenting with evidence of recent or prior hemorrhage
- Have received prior BAVM therapy (endovascular, surgical, radiotherapy)
- Have a known allergy against iodine contrast agents
- Have an ailment reducing life expectancy to less than 10 years
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.