ARUBA
Unruptured Brain Arteriovenous Malformations Trial [SPOTRIAS]
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Status:
Ongoing. Study is currently recruiting patients and centers.
Purpose:
To determine if medical management improves long-term outcomes of patients with unruptured brain arteriovenous malformations (AVMs) compared to invasive treatment.
Location(s):
U.S., Europe, South America, Australia, and Canada.
Year Started:
2007
Design:
International, multicenter, randomized, controlled, open, prospective clinical trial.
Inclusion Criteria
Patients diagnosed with an unruptured brain AVM considered treatable by the local investigators.
Exclusion Criteria
Patient has evidence of recent or prior BAVM hemorrhage; has received prior BAVM therapy (endovascular, surgical, radiotherapy); has BAVM deemed untreatable by local investigator, or has concomitant vascular or brain disease that interferes with/or contradicts any invasive therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons); has baseline Rankin ≥2; concomitant disease reducing life expectancy to less than 10 years; thrombocytopenia (< 100,000/nl) or coagulopathy (spontaneous or iatrogenic INR>1.5, PT>30);
pregnant or lactating; known allergy against iodine contrast agents, multiple-foci BAVMs, or any form of arteriovenous or spinal fistulas; diagnosed Vein of Galen type malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome; diagnosed BAVMs in context of moya-moya-type changes, or hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber).
Patient Involvement:
Patients will be randomly assigned to invasive therapy (endovascular, surgical, and/or radiation therapy) versus medical management alone. Patients will be followed for a minimum of 5 years and a maximum of 7.5 years (mean 6.25 years) from randomization. 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
Primary Outcome:
The composite event of death from any cause or stroke (hemorrhage or infarction confirmed by imaging).
Secondary Outcome:
Risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization.
Clinical outcome status will be measured by the Rankin Scale, NIHSS, and EuroQual.
Source of Information:
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference [February 2008].
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Web Links and Publications:
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This information last updated on: 2/1/2010
Reviewed on: 01/26/2010.
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