Clinical Trial Details
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NCT00389181 : A Randomized Trial of Unruptured Brain AVMs
PhasePhase 3
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patient must have unruptured BAVM diagnosed by MRI/MRA and/or angiogram

- Patient must be 18 years of age or older

Exclusion Criteria:

- Patient has evidence of recent or prior BAVM hemorrhage

- Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)

- Patient 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

- Patient has baseline Rankin ?2

- Patient has concomitant disease reducing life expectancy to less than 10 years

- Patient has thrombocytopenia (< 100,000/nl) or coagulopathy (spontaneous or
iatrogenic INR>1.5)

- Patient is pregnant or lactating

- Patient has known allergy against iodine contrast agents, multiple-foci BAVMs, or any
form of arteriovenous or spinal fistulas

- Patient has a 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

- Patient has diagnosed BAVMs in context of moya-moya-type changes, or hereditary
hemorrhagic telangiectasia (Rendu-Osler-Weber)
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