Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in hematoma volume
Overview
Brief 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).
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Participants with cSDH
All participants enrolled will be treated with the Balt coils.
-
MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment.
-
MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as:
-
MMA embolization in combination with Balt coils post-surgical debridement, or
-
MMA embolization using Balt coils alone, pre- or post-surgical debridement.
Intervention: Balt coils: (Balt USA, LLC) (Device)
Participants with cSDH
All participants enrolled will be treated with the Balt coils.
-
MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment.
-
MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as:
-
MMA embolization in combination with Balt coils post-surgical debridement, or
-
MMA embolization using Balt coils alone, pre- or post-surgical debridement.
Intervention: MMA embolization (Procedure)
Outcomes
Primary Outcomes
Change in hematoma volume
Time Frame: 180 days
Change in hematoma volume based on CT imaging
Change in maximal thickness
Time Frame: 180 days
Change in maximal thickness based on CT imaging
Change in midline shift
Time Frame: 180 days
Change in midline shift (mm) based on CT imaging
Number of periprocedural major disabling stroke or any death
Time Frame: 30 days
Number of periprocedural major disabling stroke or any death
Number of participants with symptomatic recurrence progression requiring retreatment
Time Frame: 180 days
Number of participants with symptomatic recurrence progression of the SDH requiring retreatment
Secondary Outcomes
- Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE(180 days)
- Number of Acute successful embolization of the target vessel(Immediately post-procedure)
- Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L)(180 days)
Investigators
Christopher P Kellner
Associate Professor
Icahn School of Medicine at Mount Sinai