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Chronic Subdural Hematoma Embolization With Detachable Coils
RecruitingObservational study
Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 prior carotid stent placement * Significant medical contraindication to angiography (kidney failure/disease) * Anatomical variations that would make MMA embolization difficult or unsafe * Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints * Pregnancy * Life expectancy ≤ 1 year
About the study
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).
What is being tested
- Balt coils: (Balt USA, LLC) (device)
- MMA embolization (procedure)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 150 · Started: Jun 2, 2026
Contact the study team
- Sukaina Davdani · Phone: (212) 241-2524
- Sydney Edwards · Phone: (212) 241-2524
Official record on ClinicalTrials.gov — NCT07291427
Locations in the U.S.
| Arizona | Carondelet Neurological Institute, Tucson (Not yet recruiting) |
| California | University of California - San Deigo, San Deigo (Not yet recruiting) John Muir Health, Walnut Creek |
| Kentucky | University of Louisville, Louisville (Not yet recruiting) |
| Oklahoma | Oklahoma University Medical Center, Oklahoma City (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.