A randomised trial of unruptured brain arteriovenous malformations

Not Applicable

Completed

• Conditions: nruptured brain arteriovenous malformation; Circulatory System; Arteriovenous malformation of cerebral vessels

• Registration Number: ISRCTN44013133
• Lead Sponsor: IH - National Institute of Neurological Disorders and Stroke (USA)

Brief Summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19953376 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24268105 2020 5-year follow-up results in https://pubmed.ncbi.nlm.nih.gov/32562682/ (added 22/06/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-11
• Study Completion: 2014-03-01
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 226

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified