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Recruiting NCT07291427

Chronic Subdural Hematoma Embolization With Detachable Coils

— Observational Chronic Subdural Hemorrhage (cSDH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Balt coils: (Balt USA, LLC), MMA embolization.
Who it may be relevant to
Registry conditions: Chronic Subdural Hemorrhage (cSDH). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils

Overview

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

  • Device Balt coils: (Balt USA, LLC)
    MMA embolization utilizing Balt Coils
  • Procedure MMA embolization
    surgical or bedside evacuation pre or post-surgical debridement

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE [Time frame: 180 days]
  • Number of Acute successful embolization of the target vessel [Time frame: Immediately post-procedure]
  • Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L) [Time frame: 180 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Mount Sinai Hospital — New York

Identifiers

NCT: NCT07291427 · STUDY-25-01365

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗