Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Deigo, California and other locations
Dates
study started
study ends around

Description

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).

Official Title

Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils

Details

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 a more complete understanding of Middle Meningeal Artery Embolization (MMAE) in diverse clinical environments, inform future prospective studies, and guide evidence-based adoption of this evolving therapy. Patients may be treated with Balt coils regardless of enrollment in the study as the decision to place the coils should be made independently as per standard of care and prior to enrollment in the study.

Keywords

Chronic Subdural Hemorrhage (cSDH), Subdural hemorrhage, Coils, Middle meningeal artery, Hematoma, Subdural, Chronic, Subdural Hematoma, Balt coils: (Balt USA, LLC), MMA embolization

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • University of California - San Deigo not yet accepting patients
    San Deigo California 92093 United States
  • Carondelet Neurological Institute not yet accepting patients
    Tucson Arizona 85711 United States
  • John Muir Health accepting new patients
    Walnut Creek California 94598 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Icahn School of Medicine at Mount Sinai
ID
NCT07291427
Study Type
Observational [Patient Registry]
Participants
Expecting 150 study participants
Last Updated