| OBJECTIVES | To investigate the effect of adjunctive middle meningeal artery embolization (MMAe) with SQUID™ (Balt USA), a non-adhesive liquid embolic agent, on the risk of treatment failure among patients receiving either surgical (burr-hole evacuation or subdural evacuating port system [SEPS] drainage) or nonsurgical standard treatment for chronic subdural hematoma. |
| STUDY | Prospective, international, multicenter, open-label, interventional, randomized 1:1 controlled trial, conducted from November 2020 to May 2023 at 32 participating sites in the United States (1-year follow-up is ongoing). |
| POPULATION | Patients ≥30 years of age with pre-morbid mRS 0-1 within the previous 12 months, diagnosis of chronic subdural hematoma (cSDH) defined as ≥50% of the volume is isodense or hypodense to normal; cortical gray matter on CT imaging, thickness of the cSDH ≥10 mm, and mass effect upon the subjacent brain-local cortical flattening or midline shift resulting in clear neurological symptoms (headache, cognitive decline, speech difficulty, aphasia, gait impairment). |
| ENDPOINTS | The primary efficacy endpoint was a composite of treatment failure defined as recurrent or residual SDH ≥10 mm at 180 days; reoperation or surgical rescue within 180 days after intervention; or major disabling stroke, myocardial infarction, or death from any neurological cause within 180 days after intervention. The primary safety endpoint was a composite of major disabling stroke or death from any cause within 30 days from intervention. |