Chronic Subdural Hemorrhage (cSDH)
Conditions
Keywords
Subdural hemorrhage, Coils, Middle meningeal artery
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.
Interventions
DEVICEBalt coils: (Balt USA, LLC)
MMA embolization utilizing Balt Coils
PROCEDUREMMA embolization
surgical or bedside evacuation pre or post-surgical debridement
Sponsors
Icahn School of Medicine at Mount Sinai
John Muir Health
Carondelet Neurological Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hematoma volume | 180 days | Change in hematoma volume based on CT imaging |
| Change in maximal thickness | 180 days | Change in maximal thickness based on CT imaging |
| Change in midline shift | 180 days | Change in midline shift (mm) based on CT imaging |
| Number of periprocedural major disabling stroke or any death | 30 days | Number of periprocedural major disabling stroke or any death |
| Number of participants with symptomatic recurrence progression requiring retreatment | 180 days | Number of participants with symptomatic recurrence progression of the SDH requiring retreatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE | 180 days | Number of Adverse events and serious adverse events related to the device as assessed by an independent medical monitor |
| Number of Acute successful embolization of the target vessel | Immediately post-procedure | Determination of successful embolization based on angiographic imaging |
| Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L) | 180 days | The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L, each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from \<0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Lower scores indicate a higher QoL. |
Countries
United States
Contacts
CONTACTSukaina Davdani
CONTACTSydney Edwards
PRINCIPAL_INVESTIGATORChristopher Kellner
Icahn School of Medicine at Mount Sinai
PRINCIPAL_INVESTIGATORBenjamin Yim
John Muir Health
PRINCIPAL_INVESTIGATORAlexander Coon
Carondelet Neurological Institute
Outcome results
None listed