Chronic Subdural Hematoma Embolization With Detachable Coils (SEED)

Mount Sinai Health System

Status: Begins enrollment this month

Conditions: Chronic Subdural Hemorrhage (cSDH)

Treatments: Procedure: MMA embolization; Device: Balt coils: (Balt USA, LLC)

Study type: Observational

Funder types: Other

Identifiers

NCT07291427

STUDY-25-01365

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Participants with cSDH

Description:

All participants enrolled will be treated with the Balt coils. 1. MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment. 2. MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as: 1. MMA embolization in combination with Balt coils post-surgical debridement, or 2. MMA embolization using Balt coils alone, pre- or post-surgical debridement.

Treatment:

Device: Balt coils: (Balt USA, LLC)

Procedure: MMA embolization