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RECRUITING
NCT07541404
NA

MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

Sponsor: Arsenal Medical, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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

DEVICE

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