Chronic Subdural Hematoma Embolization With Detachable Coils

NCT07291427 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY-25-01365
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Subdural Hemorrhage (cSDH)

Keywords

Subdural hemorrhage; Coils; Middle meningeal artery

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

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

Interventions

Balt coils: (Balt USA, LLC) DEVICE

MMA embolization utilizing Balt Coils

Also known as: Optima, OptiMax, OptiBlock, Optima series line extensions

Participants with cSDH

MMA embolization PROCEDURE

surgical or bedside evacuation pre or post-surgical debridement

Participants with cSDH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• John Muir Health: collaborator
• Carondelet Neurological Institute: collaborator

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Christopher Kellner

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Benjamin Yim

  John Muir Health

  PRINCIPAL INVESTIGATOR

• Alexander Coon

  Carondelet Neurological Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukaina Davdani

CONTACT

(212) 241-2524; Sukaina.Davdani@mountsinai.org

Sydney Edwards

CONTACT

(212) 241-2524; Sydney.Edwards@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)