Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
Sanford Health
Summary
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.
Description
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, rec…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceParticles (polyvinyl alcohol or similar microspheres)
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
- DeviceLiquid Embolics (Onyx, n-BCA, or equivalent)
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
- DevicePhenox Coils (Avenir UNO Helical Coil)
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Location
- Sanford USD Medical CenterSioux Falls, South Dakota