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

Part of paid clinical trials in Sioux Falls, South Dakota.

Sponsor: Sanford Health
Study ID: NCT07757113
Status: Not Yet Recruiting

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Conditions

Chronic Subdural Hematoma
Middle Meningeal Artery Embolization
Stroke

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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.

Study Details

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.

Key Dates

First listed: Aug 11, 2026
Start date: Sep 30, 2026
Status verified: Jul 2026
Primary completion: Sep 30, 2027
Completion: Mar 31, 2028

Study Design

Enrollment: 30 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: MMA Embolization
Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared.