A Phase 3 interventional study of Interventional therapy and Medical management in Arteriovenous Malformations, Cerebral, sponsored by Columbia University. Completed at 66 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-04.
Sponsored by Columbia University · Phase 3, Interventional, and Treatment
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.
141 studies on the registry are indexed under Hemangioma; 16 are open to participants now.
This study's enrollment of 226 is above the median of 50 across 80 interventional studies indexed under Hemangioma.
Browse Hemangioma studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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Exclusion Criteria:
Patient has any form of arteriovenous or spinal fistulas
Previous diagnosis of any of the following -
Patients with unruptured BAVMs will receive symptomatic medical management alone.
Other: Medical management
Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).
Procedure: Interventional therapy · Other: Medical management
All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings.
Patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction.
Difference of 5-year event rates between two arms
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.
Time frame: 5 years
Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention
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)
Time frame: 5 years
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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