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. 2019 Sep 10;2019(9):CD003436. doi: 10.1002/14651858.CD003436.pub4

NCT00857662.

Trial name or title US multicenter, randomized controlled study comparing the performance of Onyx(EVOH) and TRUFILL® (n‐BCA) in presurgical embolization of brain arteriovenous malformations (BAVMs)
Methods Multicentre, prospective, randomized, controlled, open label, clinical trial
Participants Patients of any age, diagnosed with a brain AVM (with a Spetzler‐Martin grade of I, II, III, or IV) and the patient is a candidate for surgical resection of the AVM post embolization
Interventions Onyx (investigational device) versus TRUFILL (control device) in the presurgical embolization of brain AVMs
Outcomes Primary outcome measures
  • angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization


Secondary outcome measures
  • Safety will be assessed by the nature and severity of adverse events

  • Surgical blood loss

  • Surgical resection time

Starting date May 2001
Contact information Gary Duckwiler MD
Notes Sponsor: Medtronic Neurovascular Clinical Affairs