Evaluating TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System as a treatment of chronic subdural hematoma (cSDH)

The objective of this study is to evaluate the safety and effectiveness of TRUFILLP Pn-BCA for MMA embolization in patients presenting with a cSDH compared to patients treated with standard of care management. Residual or re-accumulation of the cSDH (more than 10 mm) at 6 months as assessed by an independent core laboratory OR re-operation or surgical procedure on the SDH within 6 months post randomization. Re-operation and surgical procedures will be reported by the site. Hematoma size will be assessed by the independent core laboratory. Secondary Endpoints: Effectiveness 1. Mean reduction of hematoma volume at 3, 6 and 12 months compared to baseline, as assessed by an independent core laboratory 2. Reduction more than 50% in hematoma volume at 3, 6 and 12 months as assessed by an independent core laboratory 3. Complete resolution of the cSDH at 3, 6 and 12 months as assessed by an independent core laboratory 4. Median time to achieve complete resolution of the cSDH 5. Subjects that develop an acute component of their existing cSDH or a new cSDH at 3, 6 and 12 months as assessed by an independent core laboratory 6. Subjects requiring a surgical procedure on the SDH within 3, 6 and 12 months post randomization 7. Subjects requiring more than one surgical procedure on the SDH within 3, 6 and 12 months post randomization Re-operation and surgical procedures will be reported by the site. Hematoma volume and resolution, as well as identification of an acute component of the cSDH or a new SDH will be assessed by the independent core laboratory. Secondary Endpoints: Safety 1. mRS distribution change at 3, 6 and 12 months 2. Death, stroke, myocardial infarction or thromboembolic complications within 3, 6 and 12 months as assessed by the Clinical Events Committee (CEC) 3. Development of new onset of seizures within 3, 6 and 12 months as assessed by the CEC 4. Change in Markwalder Grading Scale at 3, 6 and 12 months compared to baseline 5. Change in Mini-Mental State Exam MMSE score at 6 months compared to baseline Death, stroke, myocardial infarction, thromboembolic complications and new onset seizures will be adjudicated by the CEC. Markwalder and mRS used in secondary endpoints will be assessed by a qualified independent evaluator who is not part of the interventional (embolization) treating team and not involved in patient care or data entry and is blinded to study treatment assignment. Secondary Endpoints Health Economics 1. Hospital days and intensive care unit (ICU) days 2. Change in EQ-5D-5L score at discharge and 6 months compared to baseline