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.
Age 40-90 years inclusively.
Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment (at least 10 mm in thickness) and the contralateral side is asymptomatic and < 10 mm in thickness.
CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
Qualifying baseline head CT performed within the 7 days prior to randomization.
Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
Tentorial or interhemispheric SDH.
Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
Pre CSDH mRS of 5 or higher.
Parallel
Conventional Surgery
Procedure/SurgeryConventional surgery is surgical drainage through burr holes or craniotomy.
Middle Meningeal Artery Embolization (MMAE)
DeviceParticle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Need for Rescue Surgery or Death
Participants who need rescue surgery or die.
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.
Click on the lead sponsor to view all of their trials.
The University of Texas Medical Branch, Galveston
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
