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NCT07291427From ClinicalTrials.govRecruiting

Chronic Subdural Hematoma Embolization With Detachable Coils

Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils

  • Chronic Subdural Hemorrhage (cSDH)

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Icahn School of Medicine at Mount Sinai
Enrolment target
150
Started
2 June 2026
Main results due
1 September 2028
Study sites
5
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(5)

  • Carondelet Neurological Institute

    Tucson, Arizona, United States

    Not yet recruiting

  • University of California - San Deigo

    San Deigo, California, United States

    Not yet recruiting

  • John Muir Health

    Walnut Creek, California, United States

    Recruiting

  • University of Louisville

    Louisville, Kentucky, United States

    Not yet recruiting

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, United States

    Not yet recruiting

Showing 5 of 5 sites. 1 of the 5 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07291427. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Chronic Subdural Hematoma Embolization With Detachable Coils | Trialion