Icahn School of Medicine at Mount Sinai
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…
Inclusion criteria: * Age ≥ 18 * Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed. * A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study. * Signed informed consent obtained by patient or Legal Authorized Representative (LAR) Exclusion criteria: * Primary acute SDH * Prior MMAE in target territory * Premorbid mRS \> 3 * Common carotid stenosis \>70% or pr…
MMA embolization utilizing Balt Coils
surgical or bedside evacuation pre or post-surgical debridement
Arctuva estimate
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