N/A
N=376
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Chronic Subdural Hematoma
Bottom Line
View on ClinicalTrials.gov: NCT04816591 ↗Enrolled (actual)
376
Serious AEs
38.3%
Results posted
Feb 2026
Primary outcome: Primary: Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any Re-operation or Surgical Procedure on the cSDH at 6 Months — 8.5; 20.2; 20.0; 27.0 Percentage of Participants — p==0.044
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (Device); Standard of Care Surgery (Other); Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System (Device); Standard of Care Medical Management (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any Re-operation or Surgical Procedure on the cSDH at 6 Months |
8.5; 20.2; 20.0; 27.0 | =0.044 sig |
| PRIMARY Percentage of Participants With All Adverse Events (AEs) |
68.5; 66.9; 80.4; 61.4 | — |
| SECONDARY Number of Participants With Good Functional Outcome at 3 Months (Modified Rankin Score [mRS] 0-2 or no Worsening From Baseline if Baseline mRS Greater Than Equal to [>=] 3) |
95; 76; 27; 28 | — |
| SECONDARY Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory |
-55.19; -59.07; -60.95; -61.95; -60.89; -72.52 | — |
| SECONDARY Number of Participants With Greater Than (>) 50 Percent (%) Reduction in Hematoma Volume at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory |
74; 56; 29; 27; 106; 88 | — |
| SECONDARY Number of Participants With Complete Resolution of the cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory |
43; 23; 15; 14; 80; 57 | — |
| SECONDARY Median Time to Achieve Complete Resolution of the cSDH |
120.8; 155.7; 120.3; 122.9 | — |
| SECONDARY Percentage of Participants Who Developed an Acute Component of Their Existing cSDH or a New cSDH (Kaplan-Meier Estimate) at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory |
7.6; 15.3; 5.9; 15.6; 10.7; 17.0 | — |
| SECONDARY Percentage of Participants Who Required a Surgical Procedure on the cSDH (Kaplan-Meier Estimate) Within 3 and 6 Months Post-Randomization |
2.3; 9.3; 7.8; 11.8; 2.3; 9.3 | — |
| SECONDARY Number of Participants Who Required More Than One Surgical Procedure on the cSDH Within 3, 6, and 12 Months Post-Randomization |
1; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants Who Required a Surgical Procedure on the cSDH Within 12 Months |
3; 13; 4; 6 | — |
| SECONDARY Number of Participants With Shift From Baseline in Modified Rankin Scale (mRS) Score at 3, 6, and 12 Months |
10; 7; 2; 3; 2; 2 | — |
| SECONDARY Number of Participants With Death, Stroke, Myocardial Infarction (MI) or Thromboembolic Complications Within 6 and 12 Months as Assessed by the Clinical Events Committee (CEC) |
1; 11; 5; 5; 1; 2 | — |
| SECONDARY Percentage of Participants With New Onset of Seizures (Kaplan-Meier Estimate) Within 3, 6, and 12 Months as Assessed by the Clinical Events Committee (CEC) |
6.8; 4.7; 3.7; 1.9; 6.8; 4.7 | — |
| SECONDARY Number of Participants With Shift From Baseline in Mini-Mental State Exam (MMSE) Score at 6 Months |
2; 3; 1; 0; 6; 5 | — |
| SECONDARY Number of Participants With Shift From Baseline in Markwalder Neurological Grading Scale (MGS) at 3, 6, and 12 Months |
16; 15; 5; 7; 2; 4 | — |
| SECONDARY Hospital Days and Intensive Care Unit (ICU) Days |
12.0; 7.0; 4.0; 3.0 | — |
| SECONDARY Change From Baseline in EuroQol-5 Dimension-5 Levels (EQ-5D-5L) Score at 6 Months |
13.0; 10.7; 7.5; 9.0 | — |
Summary
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
Eligibility Criteria
Inclusion Criteria
- Pre-randomization mRS /= 3
- Glasgow Coma Scale < 9
- Presumed microbial superinfection
- CT or MRI evidence of intracranial tumor or mass lesion
- Life expectancy < 1 year
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
- Current involvement in another clinical trial that may confound study endpoints
Data sourced from ClinicalTrials.gov (NCT04816591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.