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A Randomized Multicenter Clinical Trial of Unruptured Brain AVMs (ARUBA)

Lead Physician: P. Roc Chen, M.D.

ARUBA is an FDA and institutional IRB approved randomized multicenter international clinical trial designed to determine whether medical management improves long-term outcomes of patients with unruptured brain AVMs, compared to interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination). This trial tests whether medical management or interventional therapy will reduce the risk of death or stroke (due to hemorrhage or infarction) by at least 46 percent (an absolute magnitude of about 9.5 percent over 5 years). A total of 400 patients will be enrolled in order to detect the hypothesized 46 percent reduction in event rate, analyzed using the intention-to-treat principal. This sample size supports a test of non-inferiority if medical management is not superior to interventional therapy. Patients are followed for a minimum of 5 years and a maximum of 10 years from randomization.