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.
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
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)
Single group
Particles (polyvinyl alcohol or similar microspheres)
DeviceParticipants 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)
DeviceParticipants 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)
DeviceParticipants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Change in hematoma size
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.
Complications
The secondary objectives aim to evaluate the safety profile of the embolic materials, to support overall comparative effectiveness.
Recurrence Rates
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Adverse Events
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Re-Intervention Rates
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
Click on the lead sponsor to view all of their trials.
Sanford Health
Lead sponsor
phenox Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
