Balt Coils with MMA Embolization for Chronic Subdural Hematoma
Official title: Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils
Run by Icahn School of Medicine at Mount Sinai · NCT07291427 · Data updated 2026-11-12
This registry is testing whether using Balt coils during middle meningeal artery embolization is safe and helps patients with chronic subdural hematoma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 5 sites (Tucson, Arizona and 4 other locations) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07291427 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with unilateral or bilateral non-acute subdural hematoma who are treated with coiling and/or embolics as part of their standard care.
✕Probably not a fit
Patients with primary acute SDH, prior MMA embolization in the target territory, or other contraindications may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multi-center registry evaluating the safety and effectiveness of Balt coils as an adjunct to MMA embolization in adults with chronic subdural hematoma. Data will be collected on procedural details, radiographic and clinical outcomes, and variations in practice settings to understand real-world use. The study does not require that all patients receive coils for enrollment, and decisions about coil placement are made as part of standard care before enrollment. Results aim to inform future research and guide evidence-based adoption of MMA embolization for cSDH.
Why it matters
Potential benefit: If successful, the approach could improve safety and outcomes for patients with cSDH undergoing MMA embolization.
How similar studies have gone: Other observational studies and registries have explored MMA embolization; this study builds on real-world data to further understand safety and outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
John Muir Health
Walnut Creek, California, United States Recruiting -
Carondelet Neurological Institute
Tucson, Arizona, United States Not yet recruiting -
University of California - San Deigo
San Deigo, California, United States Not yet recruiting -
University of Louisville
Louisville, Kentucky, United States Not yet recruiting -
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States Not yet recruiting
Study contacts
- Principal investigator: Christopher Kellner — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sukaina Davdani
- Email: Sukaina.Davdani@mountsinai.org
- Phone: (212) 241-2524
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.