Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chr… (NCT04402632) | Clinical Trial Compass
CompletedNot Applicable
Embolization of the Middle Meningeal Artery With ONYXâ„¢ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
United States600 participantsStarted 2020-10-27
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyxâ„¢ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)
Who can participate
Age range18 Years – 90 Years
SexALL
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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 Onyxâ„¢ LES
* Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization
What they're measuring
1
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline