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Department of Neurosurgery

Multi-Center Clinical Trials

A Randomized Trial of Unruptured Brain Arteriovascular Malformations (ARUBA)

Currently SUNY Downstate is participating in an interventional trial evaluating unruptured brain AVMs (ARUBA), and interested patients may enroll in this study.

Overview:

Currently there is debate regarding the need to treat unruptured brain arteriovascular malformations (AVMs). One major reason to treat AVMs is to prevent future hemorrhagic events which are potentially devastating occurrences. It has been shown that approximately twenty percent of AVMs are discovered by chance without an associated hemorrhagic event (www.sivms.org). These AVMs may exhibit a lower likelihood of bleeding than those AVMs that have hemorrhaged in the past. Since the hemorrhage risk of an AVM is critical in properly evaluating the risks and benefits of treatment, it is important to quantify the hemorrhage risk of an unruptured AVM. Without an appreciation for the hemorrhage risk of unruptured AVMs, the need to treat them remains a contentious issue.

In an attempt to answer the question "should unruptured brain AVMs be treated?" a worldwide randomized controlled trial has been organized by physicians in the United States, Europe and Australia. This study is called ARUBA, short for A Randomized Trial of Unruptured Brain AVMs, and is funded by the National Institute of Neurological Disorders and Stroke (NINDS) here in the United States. ARUBA does not receive any funding from any medical device manufacturers or pharmaceutical companies.

Patients with unruptured brain AVMs who wish to participate in ARUBA will be randomly assigned one of two groups: 1) a treatment group who will undergo interventional therapy for the AVM or 2) an observational group who will not undergo immediate inteventional therapy. Interventional therapy includes neurosurgical resection, neurointerventional occlusion and stereotactic radiosurgery. These two patient groups will be followed over a 5 year period.

Goals of the ARUBA Study:

ARUBA hopes to determine if medical management is equivalent or superior in the prevention of death, stroke and disability when compared to invasive therapeutic modalities.

In addition to this primary objective ARUBA will look for significant differences between the two treatment groups with respect to: post treatment quality of life, survival, adverse events, economic impacts, and outcomes based upon anatomic features of the unruptured AVMs.

ARUBA Patient Selection

In order to be included in the ARUBA study a patient must be an adult with a potentially treatable unruptured brain AVM. All patients who meet eligibility criteria may be included in the study regardless of gender, race, or ethnicity.

Inclusion Criteria:

  1. Unruptured AVM studies with MRI, MRA, CT angiography or conventional cerebral angiography.
  2. Be 18 years of age or older.
  3. Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms

Exclusion Criteria:

  1. Patient has brain AVM presenting with evidence of recent or prior hemorrhage
  2. Patient has received prior brain AVM therapy (endovascular, surgical, radiotherapy)
  3. Patient has brain AVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
  4. Patient has baseline Rankin ≥2
  5. Patient has concomitant disease reducing life expectancy to less than 10 years
  6. Patient has thrombocytopenia (< 100,000/µL)
  7. Patient has uncorrectable coagulopathy (INR>1.5)
  8. Patient is pregnant or lactating
  9. Patient has known allergy against iodine contrast agents
  10. Patient has multiple-foci brain AVMs
  11. Patient has any form of arteriovenous or spinal fistulas

Previous diagnosis of any of the following:

  1. Patient has a diagnosed Vein of Galen type malformation
  2. Patient has a diagnosed cavernous malformation
  3. Patient has a diagnosed dural arteriovenousfistula
  4. Patient has a diagnosed venous malformation
  5. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
  6. Patient has diagnosed brain AVMs in context of moya-moya-type changes
  7. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)