Status:
COMPLETED
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Subdural Hematoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04402632
Start Date
October 27 2020
End Date
April 3 2025
Last Update
December 11 2025
Active Locations (49)
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1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233-1932
2
Carondelet St. Joseph's Hospital
Tucson, Arizona, United States, 85710
3
University of California Irvine Medical Center
Irvine, California, United States, 92868
4
USC - Keck School of Medicine
Los Angeles, California, United States, 90033