The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
520
Conventional surgery is surgical drainage through burr holes or craniotomy.
Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Mayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGBaptist Medical Center Jacksonville
Jacksonville, Florida, United States
RECRUITINGUniversity of Miami Miller School of Medicine
Miami, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
Need for Rescue Surgery or Death
Participants who need rescue surgery or die.
Time frame: Within 180-210 days of randomization
Safety of MMAE and Conventional Open Surgery
The proportion of subjects with symptomatic ischemic stroke, serious/life threatening adverse events, worsening of neurological status (a decline of 1 point on the Markwalder scale) or development of new disabling neurological symptoms, seizures, and/or cranial neuropathy.
Time frame: Within 180 days of randomization.
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Emory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITING...and 20 more locations