Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma

OBJECTIVES	To evaluate the safety and efficacy of embolization of the middle meningeal artery using Onyx™ liquid embolic for treatment of symptomatic subacute or chronic subdural hematoma.
STUDY	Multicenter, prospective randomized, interventional, controlled, open-label, adaptive design, IDE clinical trial across 60 sites in the USA. Two separate cohorts (Surgery and Observation).
POPULATION	Patients 18-90 years of age with a diagnosis of subacute/chronic subdural hematoma on CT or MRI with acute blood volume <50%. Treatment, intended to treat the SDH surgically, midline shift ≥5 mm, hematoma thickness >15 mm.
ENDPOINTS	The primary endpoint is the rate of hematoma recurrence/progression requiring surgical drainage within 90 days post-treatment. Secondary clinical endpoints included a non-inferiority assessment of Onyx™ liquid embolic treatment compared to standard of care based on the deterioration of neurological function of 90 days (defined as mRS ≥ at 90 days. Safety endpoints included device and procedure-related serious adverse events (AEs) up to 30 days and incidence of neurological death up to 90 and 180 days. Secondary effectiveness endpoints included hospital readmissions at 90 days, change in hematoma volume, midline shift, and percent change in hematoma thickness at 90 days compared to baseline.

Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma - EMBOLISE