Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: October 27, 2020
End Date: April 01, 2023
Medtronic Neurovascular Clinical Affairs
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Inclusion Criteria:
- Pre-morbid Modified Rankin Score ≤3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
Exclusion Criteria:
- Life expectancy <1 year
- Unable to complete follow-up
- Pregnant, lactating, or has a positive pregnancy test at time of admission
- Bilateral subacute or chronic SDH
- Previous surgical interventions for subacute or chronic SDH
- Unable to undergo MMA embolization prior to surgical treatment
- Acute SDH
- Potentially dangerous anatomic variations leading to increased procedural risk
- Contraindicated for removal from anticoagulant medical therapy for at least 4 weeks post-randomization
- Pre-randomized Markwalder Grading Scale score ≥ 3
- Unmanaged, uncontrolled bleeding disorders/blood diathesis
- International normalized ratio [INR] ≤1.4
- Presumed septic embolus, or suspicion of microbial superinfection
- 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 Onyx™ LES
- Contraindicated for removal of corticosteroids for at least 90 days post-randomization
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Conditions:
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
- Hematoma