This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).
The primary objective of this observational registry study is to assess the safety and efficacy of Balt Coils as an adjunct to middle meningeal artery (MMA) embolization in a real-world setting among patients undergoing treatment for chronic subdural hematoma (cSDH), and explore correlations between patient characteristics, clinical characteristics, and outcomes. By collecting comprehensive, real-world data, the registry will characterize procedural inputs, document clinical and radiographic outcomes, and explore variation in technique and practice setting. The overarching goal is to generate a more complete understanding of Middle Meningeal Artery Embolization (MMAE) in diverse clinical environments, inform future prospective studies, and guide evidence-based adoption of this evolving therapy. Patients may be treated with Balt coils regardless of enrollment in the study as the decision to place the coils should be made independently as per standard of care and prior to enrollment in the study.
Study Type
OBSERVATIONAL
Enrollment
150
MMA embolization utilizing Balt Coils
surgical or bedside evacuation pre or post-surgical debridement
Mount Sinai Hospital
New York, New York, United States
Change in hematoma volume
Change in hematoma volume based on CT imaging
Time frame: 180 days
Change in maximal thickness
Change in maximal thickness based on CT imaging
Time frame: 180 days
Change in midline shift
Change in midline shift (mm) based on CT imaging
Time frame: 180 days
Number of periprocedural major disabling stroke or any death
Number of periprocedural major disabling stroke or any death
Time frame: 30 days
Number of participants with symptomatic recurrence progression requiring retreatment
Number of participants with symptomatic recurrence progression of the SDH requiring retreatment
Time frame: 180 days
Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE
Number of Adverse events and serious adverse events related to the device as assessed by an independent medical monitor
Time frame: 180 days
Number of Acute successful embolization of the target vessel
Determination of successful embolization based on angiographic imaging
Time frame: Immediately post-procedure
Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L, each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from \<0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Lower scores indicate a higher QoL.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 180 days