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MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
Sponsor: Arsenal Medical, Inc.
Summary
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH) adjunctive to surgery.
Official title: Pivotal Study of the Treatment of Symptomatic Subacute and Chronic Subdural Hematoma Via Middle Meningeal Artery Embolization With the NeoCastTM Embolic System (RADIANT)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-08-13
Completion Date
2028-04
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
NeoCast Embolic System
NeoCast will be used to embolize a participant's middle meningeal artery in an endovascular procedure before or after adjunctive surgery to drain the hematoma
Onyx LES, an FDA-Approved Commercial Liquid Embolic
Onyx LES, an FDA-approved commercial liquid embolic, will be used to embolize a participant's middle meningeal artery in an endovascular procedure before or after adjunctive surgery to drain the hematoma
Locations (2)
Yale Neurosciences Institute
New Haven, Connecticut, United States
University of Washington Medicine - Harborview Medical Center
Seattle, Washington, United States