Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
- Conditions
- Subdural Hematoma
- Registration Number
- NCT04402632
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- 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 or chronic subdural hematoma (SDH)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- Pre-morbid Modified Rankin Score ≤3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
- Meets criteria for Surgery or Observation Cohort
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline 90 days post-procedure
- Secondary Outcome Measures
Name Time Method Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score 90 days post-procedure Safety: Incidence of neurological death 90 days and 180 days post-procedure Safety: Incidence of device-related adverse events 90 days and 180 days post-procedure Effectiveness: Change in hematoma thickness per CT/MRI imaging 90 days post-procedure Safety: Incidence of procedure-related serious adverse events 30 days post-procedure Safety: Incidence of device-related serious adverse events 30 days post-procedure Effectiveness: Incidence of hospital readmissions 90 days post-procedure Effectiveness: Change in hematoma volume based on CT/MRI imaging 90 days post-procedure Effectiveness: Change in midline shift based on CT/MRI imaging 90 days post-procedure
Related Research Topics
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Trial Locations
- Locations (49)
University of Alabama at Birmingham (UAB) Hospital
🇺🇸Birmingham, Alabama, United States
Carondelet St. Joseph's Hospital
🇺🇸Tucson, Arizona, United States
University of California Irvine Medical Center
🇺🇸Irvine, California, United States
USC - Keck School of Medicine
🇺🇸Los Angeles, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Providence Little Company of Mary Medical Center
🇺🇸Torrance, California, United States
University of Colorado Denver School of Medicine
🇺🇸Aurora, Colorado, United States
Scroll for more (39 remaining)University of Alabama at Birmingham (UAB) Hospital🇺🇸Birmingham, Alabama, United States