Recruiting

Balt Coils

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07291427

Conditions

Chronic Subdural Hemorrhage (cSDH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balt coils: (Balt USA, LLC)

MMA embolization

Study Details

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)

Study ID

NCT07291427

Start date

Jun 2, 2026

Status verified date

Jul, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Balt coils: (Balt USA, LLC)

MMA embolization utilizing Balt Coils

MMA embolization

surgical or bedside evacuation

pre or post-surgical debridement

Primary outcome measure

  • Change in hematoma volume [ Time Frame: 180 days ]
  • Change in maximal thickness [ Time Frame: 180 days ]
  • Change in midline shift [ Time Frame: 180 days ]
  • Number of periprocedural major disabling stroke or any death [ Time Frame: 30 days ]
  • Number of participants with symptomatic recurrence progression requiring retreatment [ Time Frame: 180 days ]

Central Contacts and Locations

Central contacts

Sukaina Davdani

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

Sydney Edwards

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

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Sukaina Davdani

Sukaina.Davdani@mountsinai.org

Sydney Edwards

sydney.edwards@mountsinai.org

Principal Investigator:

Christopher Kellner

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Subdural hemorrhage
  • Coils
  • Middle meningeal artery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-24.