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| Name | Class |
|---|---|
| John Muir Health | OTHER |
| Carondelet Neurological Institute | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with cSDH | All participants enrolled will be treated with the Balt coils.
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balt coils: (Balt USA, LLC) | Device | MMA embolization utilizing Balt Coils |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hematoma volume | Change in hematoma volume based on CT imaging | 180 days |
| Change in maximal thickness | Change in maximal thickness based on CT imaging | 180 days |
| Change in midline shift | Change in midline shift (mm) based on CT imaging | 180 days |
| Number of periprocedural major disabling stroke or any death | Number of periprocedural major disabling stroke or any death | 30 days |
| Number of participants with symptomatic recurrence progression requiring retreatment | Number of participants with symptomatic recurrence progression of the SDH requiring retreatment | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE | Number of Adverse events and serious adverse events related to the device as assessed by an independent medical monitor | 180 days |
| Number of Acute successful embolization of the target vessel |
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Inclusion criteria:
Exclusion criteria:
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Patients with symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukaina Davdani | Contact | (212) 241-2524 | Sukaina.Davdani@mountsinai.org | |
| Sydney Edwards | Contact | (212) 241-2524 | Sydney.Edwards@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kellner | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Benjamin Yim | John Muir Health | Principal Investigator |
| Alexander Coon |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. Data that will be shared and published will be that of all participants combined to protect individual patient privacy and confidentiality.
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D006408 | Hematoma, Subdural |
| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| MMA embolization | Procedure | surgical or bedside evacuation pre or post-surgical debridement |
|
Determination of successful embolization based on angiographic imaging |
| Immediately post-procedure |
| Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L) | 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. | 180 days |
| Carondelet Neurological Institute |
| Principal Investigator |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |