Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

Percentage of participants and odds ratio (OR) of participants with residual or re-accumulation of the cSDH (>10 mm) at 6 months as assessed by an independent core laboratory or re-operation or surgical procedure on the cSDH at 6 months post-randomization in the treatment with eMMA vs. standard of care is represented. Residual or re-accumulation of the cSDH >10 mm was a threshold included in the guidelines for surgical evacuation and was considered to be of prognostic importance given its association with mortality, decreased quality of life, and complications from new or repeat procedures.

An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All AEs including both serious and non serious were reported.

Participants were considered to have a good functional outcome if the 3-month mRS was less than or equal to (<=) 2 or otherwise no worsening from baseline mRS if the baseline mRS was >=3. mRS was used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scales ranges from 0-6, as follows: 0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead; higher values reflecting more severe disability or death.

Hematoma volume was assessed by independent core laboratory. An independent imaging core laboratory was utilized to provide an unbiased and standardized assessment of study imaging. Hematoma volume was calculated using the ABC/2 method (multiplying Diameters A, B, and C and dividing by 2), where Diameter A was defined as the largest length in the axial plane to each corner of the SDH, Diameter B was defined as the maximum with 90 degree to Diameter A in the same slice, Diameter C was defined as the maximum height of the hematoma. For the calculation of the height, the number of slices with visible hematoma was multiplied by the thickness of the CT-scan. Change from baseline was defined as: post-baseline value minus baseline value, with negative values indicating improvement with respect to baseline (a reduction in hematoma volume). Baseline was defined as the last non-missing measurement collected prior to randomization.

Hematoma volume was assessed by independent core laboratory. An independent imaging core laboratory was utilized to provide an unbiased and standardized assessment of study imaging. Hematoma volume was calculated using the ABC/2 method (multiplying Diameters A, B, and C and dividing by 2), where Diameter A was defined as the largest length in the axial plane to each corner of the SDH, Diameter B was defined as the maximum with 90 degree to Diameter A in the same slice, Diameter C was defined as the maximum height of the hematoma. For the calculation of the height, the number of slices with visible hematoma was multiplied by the thickness of the CT-scan. Hematoma volume reduction (%) was calculated as: (post-baseline hematoma volume minus baseline volume) divided by baseline volume *100%. A reduction >50% was defined as a decrease in hematoma volume of more than half compared with baseline. Baseline was defined as the last non-missing measurement collected prior to randomization.

Number of participants with complete resolution of the cSDH at 3, 6, and 12 months as assessed by an independent core laboratory was reported. Complete resolution was defined as the absence of measurable cSDH on CT imaging, with no residual collection visible on the evaluated slices.

Median time to achieve complete resolution was estimated as the time point corresponding to a 50% probability of resolution of the cSDH based on the core laboratory evaluations. cSDH was evaluated using CT imaging reviewed by an independent blinded core laboratory. Complete resolution was defined as the absence of measurable cSDH on CT imaging. Time to complete resolution was calculated as the number of days from baseline to the first imaging assessment demonstrating complete resolution.

Percentage of participants who developed an acute component of their existing cSDH or a new cSDH at 3, 6, and 12 months as assessed by an independent core laboratory was reported. The first incidence of an acute component of an existing cSDH or a new cSDH was considered as event. Percentages reported are Kaplan-Meier estimates of cumulative incidence.

Participants who underwent re-operation or surgical procedure on the cSDH within 3 and 6 months post randomization were reported. Percentages reported are Kaplan-Meier estimates of cumulative incidence.

Number of participants who required more than one surgical procedure on the cSDH within 3, 6, and 12 months post-randomization were reported.

Number of participants who required a surgical procedure on the cSDH within 12 months were reported.

mRS was used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scales ranges from 0-6, as follows: 0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead; higher values reflecting more severe disability or death. Baseline was defined as the last non-missing measurement collected prior to randomization.

Number of participants with death, stroke, MI or thromboembolic complications within 6 and 12 months as assessed by the CEC were reported.

Percentage of participants with new onset of seizures within 3, 6, and 12 months as assessed by the CEC were reported. Percentages reported are Kaplan-Meier estimates of cumulative incidence.

MMSE was a standardized tool to assess mental state in elderly patients. It included tests of orientation, attention, memory, language, and visual-spatial skills. It is comprised of questions (For example (e.g.), "What is the year?") and tasks (e.g., "Make up and write a sentence about anything"). MMSE scores range between 0 and 30. Scores 0-17 indicated severe cognitive impairment, scores 18-23 indicated mild impairment, and scores 24-30 were considered normal. Higher scores indicated better cognitive function. Baseline was defined as the last non-missing measurement collected prior to randomization.

Number of participants with shift from baseline in MGS at 3, 6, and 12 months was reported. The MGS is a grading system developed to evaluate neurological performance in patients with cSDH. MGS is a 5 point scale ranging from 0 to 4, where lower scores indicate less neurological impairment and higher scores indicate greater impairment. The scale is defined as follows: Grade 0: patient neurologically normal; Grade 1: patient alert and oriented with mild symptoms such as headache or mild neurologic deficit; Grade 2: patient drowsy or disoriented with variable neurologic deficit; Grade 3: patient stuporous but responsive to noxious stimuli with focal neurologic signs; and Grade 4: patient comatose with absent motor response to painful stimuli. Baseline was defined as the last non-missing measurement collected prior to randomization.

Hospital days included total length of stay in hospital (including ICU) for index procedure. ICU days included length of stay at ICU during hospitalizations for index procedure.

The EQ-5D-5L measured self-assessed health-related quality of life based on five categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each area was rated on a scale that described the degree of problems in that area (that is (i.e.)., "I had no problems walking about," "slight problems," "moderate problems," "severe problems," or "unable to walk"). This tool also had an overall health scale ranged from 1 to 100 to describe the condition of their health, 100 being the best imaginable. Higher scores indicating better QoL. Baseline was defined as the last non-missing measurement collected prior to randomization.