Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA (MEMBRANE)

This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

Inclusion Criteria:

• Pre-randomization mRS </= 3
• Confirmed diagnosis of chronic subdural hematoma
• Completed informed consent

Exclusion Criteria:

• Acute subdural hematoma
• Prior treatment of target subdural hematoma
• Markwalder assessment >/= 3
• Glasgow Coma Scale < 9
• Presumed microbial superinfection
• CT or MRI evidence of intracranial tumor or mass lesion
• Life expectancy < 1 year
• Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
• Current involvement in another clinical trial that may confound study endpoints