Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is to evaluate the safety and efficacy of embolization of the
middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of
symptomatic subacute or chronic subdural hematoma (SDH)
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Endovascular
Enrollment Eligibility
Inclusion Criteria:
- Pre-morbid Modified Rankin Score ≤3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
- Meets criteria for Surgery or Observation Cohort
Exclusion Criteria:
- Life expectancy <1 year
- Unable to complete follow-up
- Pregnant, lactating, or has a positive pregnancy test at time of admission
- Diagnosed with acute SDH
- Potentially dangerous anatomic variations leading to increased procedural risk or
unsafe access for MMA embolization
- Pre-randomized Markwalder Grading Scale score ≥ 3
- Unmanaged, uncontrolled bleeding disorders/blood diathesis
- Presumed septic embolus, or suspicion of microbial superinfection
- Known active COVID-19 infection
- CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to
angiography
- Participation in another clinical trial
- Contraindicated for the use of Onyx™ LES
- Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at
least 90 days post-randomization