Arteriovenous Malformations, Cerebral Clinical Trial
Official title:
A Randomized Trial of Unruptured Brain Arteriovenous Malformations
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.
Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke,
particularly in a young population. Current invasive treatment strategies are varied and
include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are
administered on the assumption that they can be achieved at acceptably minor complication
rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.
Recent data from the literature comparing initial presentation and outcome for patients with
ruptured and unruptured BAVMs have raised the possibility that such elective invasive
treatment for unruptured BAVMs may yield worse outcomes than managing patients
symptomatically with therapy. Unfortunately, no controlled clinical trials have yet been
undertaken for management of unruptured BAVMs to address these concerns. Therefore, the goal
of this randomized controlled trial is to determine if the long-term outcomes of patients
who receive medical management for symptoms (e.g., headache, seizures) associated with an
unruptured BAVM are superior to those who receive medical management and invasive therapy to
eradicate the BAVM.
Participants will be randomly assigned to receive either symptomatic medical management
alone or such management with invasive therapies (any combination of surgery, endovascular
embolization, or radiotherapy). Functional assessment will be carried out at the time of
randomization, pre-intervention and 48-hour post-intervention, and for all participants at 1
month, and at 6 month intervals throughout the follow up period which will be a minimum of 5
years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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