Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Summary

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.

Eligibility

Age range

40–90 years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Conventional Surgery

  Conventional surgery is surgical drainage through burr holes or craniotomy.

• Device
  Middle Meningeal Artery Embolization (MMAE)

  Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.

Locations (31)