Clinical Trial: A Randomized Trial of Unruptured Brain AVMs

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Trial of Unruptured Brain Arteriovenous Malformations

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Columbia University

Current Primary Outcome: Difference of 5-year event rates between two arms [ Time Frame: 5 years ]

The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.


Original Primary Outcome: Composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging)

Current Secondary Outcome: Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention [ Time Frame: 5 years ]

The hypothesis to be tested is that early intervention decreases the risk of death or clinical impairment at 5 years post-randomization. (Rankin Score >/= 2)


Original Secondary Outcome: Risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization

Information By: Columbia University

Dates:
Date Received: October 16, 2006
Date Started: October 2006
Date Completion:
Last Updated: June 2, 2015
Last Verified: June 2015