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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Medical Management (Control)
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
Time frame: 90 days post-procedure
Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
Time frame: 90 days post-procedure
Effectiveness: Incidence of hospital readmissions
Time frame: 90 days post-procedure
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Time frame: 90 days post-procedure
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Time frame: 90 days post-procedure
Effectiveness: Change in midline shift based on CT/MRI imaging
Time frame: 90 days post-procedure
Safety: Incidence of device-related serious adverse events
Time frame: 30 days post-procedure
Safety: Incidence of procedure-related serious adverse events
Time frame: 30 days post-procedure
Safety: Incidence of neurological death
Time frame: 90 days and 180 days post-procedure
Safety: Incidence of device-related adverse events
Time frame: 90 days and 180 days post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Surgical Evacuation of the Subdural Hematoma (SDH)
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
...and 39 more locations