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NCT Number: NCT07757113

Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization

Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

About this study

Participants will be sequentially enrolled into one of three treatment arms based on the embolic material used during their MMA embolization:

Cohort/Arm 1: Particles (polyvinyl alcohol or similar microspheres) Cohort/Arm 2: Liquid embolics (Onyx, n-BCA, or equivalent) Cohort/Arm 3: Phenox coils (Avenir UNO Helical Coil) Participants will remain on study through their standard 30- and 90-day follow-up visits.

With a target of 30 patients (10 per arm), the study will provide preliminary data on radiographic efficacy (primary: hematoma resolution/thickness reduction), safety (complications, recurrence, adverse events, reinterventions), and exploratory outcomes (symptom/functional improvement, procedural metrics, influence of comorbidities/antithrombotics).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18 years)
  • Undergoing Middle Meningeal Artery Embolization (MMAE) for chronic subdural hematoma (cSDH)
  • Able to provide informed consent or have a legally authorized representative (LAR) do so

Exclusion criteria

  • Ineligible for MMAE procedure, as deemed by the treating physician, for any indication (e.g. pregnancy)
  • Non-chronic subdural hematoma (cSDH) indications for Middle Meningeal Artery Embolization (MMAE), including acute subdural hematoma with symptom onset < 72 hours or mixed acute/chronic without predominant chronic features
  • Pregnancy or breastfeeding
  • Known severe allergy or contraindication to embolic materials (e.g. particles, liquids like Onyx/n-BCA, or coils)
  • Inability to undergo angiography (e.g. severe renal impairment contraindicating contrast)
  • Inability or unwillingness to complete follow-up visits at 30 and 90 days

Treatment and study plan

Particles (polyvinyl alcohol or similar microspheres)

Device

Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.

Liquid Embolics (Onyx, n-BCA, or equivalent)

Device

Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.

Phenox Coils (Avenir UNO Helical Coil)

Device

Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.

Primary outcomes

  1. Change in hematoma size

    Time frame: Baseline, 90 days

    The primary objective aims to compare the radiographic efficacy of three embolic materials (particles, liquid embolics, Phenox coils) in MMA embolization for cSDH to evaluate change in hematoma size.

Secondary outcomes

  1. Complications

    Time frame: Baseline, 90 days

    The secondary objectives aim to evaluate the safety profile of the embolic materials, to support overall comparative effectiveness.

  2. Recurrence Rates

    Time frame: Baseline, 90 days

    The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.

  3. Adverse Events

    Time frame: Baseline, 90 days

    The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.

  4. Re-Intervention Rates

    Time frame: Baseline, 90 days

    The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.

Study contacts

Contact information is provided by the study sponsor or research team.

Alycia Abler Clinical Research Project Manager

CONTACT

[email protected]

(701) 417-2002

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Collaborators

  • phenox Inc.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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