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Chronic Subdural Hematoma Embolization With Detachable Coils

NCT ID: NCT07291427

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-09-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Chronic Subdural Hemorrhage (cSDH)

Keywords

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Subdural hemorrhage Coils Middle meningeal artery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with cSDH

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.

Balt coils: (Balt USA, LLC)

Intervention Type DEVICE

MMA embolization utilizing Balt Coils

MMA embolization

Intervention Type PROCEDURE

surgical or bedside evacuation

pre or post-surgical debridement

Interventions

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Balt coils: (Balt USA, LLC)

MMA embolization utilizing Balt Coils

Intervention Type DEVICE

MMA embolization

surgical or bedside evacuation

pre or post-surgical debridement

Intervention Type PROCEDURE

Other Intervention Names

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Optima OptiMax OptiBlock Optima series line extensions

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John Muir Health

OTHER

Sponsor Role collaborator

Carondelet Neurological Institute

UNKNOWN

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Christopher P Kellner

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Kellner

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Benjamin Yim

Role: PRINCIPAL_INVESTIGATOR

John Muir Health

Alexander Coon

Role: PRINCIPAL_INVESTIGATOR

Carondelet Neurological Institute

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Sukaina Davdani

Role: CONTACT

Phone: (212) 241-2524

Email: [email protected]

Sydney Edwards

Role: CONTACT

Phone: (212) 241-2524

Email: [email protected]

Facility Contacts

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Sukaina Davdani

Role: primary

Sydney Edwards

Role: backup

Other Identifiers

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STUDY-25-01365

Identifier Type: -

Identifier Source: org_study_id