Chronic Subdural Hematoma, Middle Meningeal Artery Embolization, Stroke
Conditions
Brief 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.
Detailed 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, recurrence, adverse events, reinterventions), and exploratory outcomes (symptom/functional improvement, procedural metrics, influence of comorbidities/antithrombotics).
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.
Sponsors
Sanford Health
phenox Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hematoma size | 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
| Measure | Time frame | Description |
|---|---|---|
| Complications | Baseline, 90 days | The secondary objectives aim to evaluate the safety profile of the embolic materials, to support overall comparative effectiveness. |
| Recurrence Rates | Baseline, 90 days | The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness. |
| Adverse Events | Baseline, 90 days | The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness. |
| Re-Intervention Rates | Baseline, 90 days | The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness. |
Countries
United States
Contacts
CONTACTAlycia Abler Clinical Research Project Manager
PRINCIPAL_INVESTIGATORDivyajot Sandhu, MD, MBBS
Sanford Health
Outcome results
None listed