Pivotal Study of the Treatment of Symptomatic Subacute and Chronic Subdural Hematoma Via Middle Meningeal Artery Embolization With the NeoCastTM Embolic System (RADIANT)
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.
Description
This is a prospective, multi-center, randomized, controlled, single-blind pivotal trial to evaluate the safety and effectiveness of the NeoCast Embolic System in embolization of the middle meningeal artery (MMA) in surgically treated patients with symptomatic subacute or chronic SDH. One hundred fifty participants will be randomized in a 2:1 ratio to be embolized with either the Arsenal Medical NeoCast Embolic System or an FDA-approved commercial embolic. The Primary Effectiveness Endpoint will be measured at the 90-day timepoint post-treatment. Participants will be followed through 180 days.
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant whose age is ≥ 18 and ≤ 90 years; * Pre-morbid mRS ≤ 2; * Confirmed diagnosis of subacute or chronic subdural hematoma that measures ≥10 mm in greatest thickness; * Participant presents with one or more of the following corroborating neurological symptoms: headache; cognitive decline; speech difficulty; gait impairment or imbalance; focal neurological deficit; and/or seizure, within the last 30 days; * Participant is planned for middle meningeal artery embolization within ±7 days of surgical evacuation of hematoma via burr hole or craniotomy; * Participant or…
Interventions
- DeviceNeoCast 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
- DeviceFDA-Approved Commercial Liquid Embolic
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 InstituteNew Haven, Connecticut
- University of Washington Medicine - Harborview Medical CenterSeattle, Washington