Unruptured brain arteriovenous malformation Circulatory System Arteriovenous malformation of cerebral vessels
Conditions
Interventions
All 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
Sponsors
NIH - National Institute of Neurological Disorders and Stroke (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must have unruptured BAVM diagnosed by Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and/or angiogram 2. Patient must be 18 years of age or older 3. Patient must have signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patient has BAVM presenting with evidence of recent or prior hemorrhage 2. Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy) 3. Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicts any invasive therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons) 4. Patient has baseline Rankin more than or equal to two 5. Patient has concomitant disease reducing life expectancy to less than ten years 6. Patient has thrombocytopenia (less than 100,000/nl) 7. Patient has coagulopathy (spontaneous or iatrogenic Inernational Normalised Ratio(INR) more than 1.5, Prothrombin Time (PT) more than 30) 8. Patient is pregnant, lactating, or plans to become pregnant 9. Patient has known allergy against iodine contrast agents 10. Patient has multiple-foci BAVMs 11. Patient has any form of arteriovenous or spinal fistulas 12. Patient has a diagnosed Vein of Galen type malformation 13. Patient has a diagnosed cavernous malformation 14. Patient has a diagnosed dural arteriovenous fistula 15. Patient has a diagnosed venous malformation 16. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome 17. Patient has diagnosed BAVMs in context of moya-moya-type changes 18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine whether medical management is superior to invasive therapy for preventing the composite outcome of death from any cause or stroke (hemorrhage or infarction confirmed by imaging) in the treatment of unruptured BAVMs 2. If medical management is not superior to invasive therapy, to determine whether medical management is not inferior to invasive therapy for preventing the composite outcome of death from any cause or stroke (hemorrhage or infarction confirmed by imaging) in the treatment of unruptured BAVMs | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether treatment of unruptured BAVMs by medical management decreases the risk of death or clinical impairment (Rankin Score more than or equal to two) at five years post-randomization compared to invasive therapy. | — |
Countries
Australia, Brazil, Canada, Czech Republic, Finland, France, Germany, Italy, Lithuania, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States of America
Outcome results
None listed