Chronic Subdural Hematoma Embolization With Detachable Coils
United States150 participantsStarted 2026-07-01
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in hematoma volume
Timeframe: 180 days
2
Change in maximal thickness
Timeframe: 180 days
3
Change in midline shift
Timeframe: 180 days
4
Number of periprocedural major disabling stroke or any death
Timeframe: 30 days
5
Number of participants with symptomatic recurrence progression requiring retreatment