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.
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. Three hundred sixty participants will be randomized in a 2:1 ratio to be embolized with either the Arsenal Medical NeoCast Embolic System or Onyx LES, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
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, will be used to embolize a participant's middle meningeal artery in an endovascular procedure before or after adjunctive surgery to drain the hematoma
Yale Neurosciences Institute
New Haven, Connecticut, United States
University of Washington Medicine - Harborview Medical Center
Seattle, Washington, United States
Comparison of NeoCast arm vs. Onyx LES arm for a composite endpoint of treatment failure events
The Primary Effectiveness Endpoint is a non-inferiority comparison of the NeoCast and Onyx LES groups for treatment failure as defined by the occurrence of any of the following events: 1. Residual or re-accumulation of the SDH (≥10 mm) on 90-day scan post-treatment (assessed by a blinded, independent Imaging Core Lab); 2. Re-operation (after index procedure) or surgical rescue within 90 days post-treatment (CEC adjudicated); 3. Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause within 90 days post-treatment (CEC adjudicated)
Time frame: 90 Days post-treatment
Safety Outcomes including Device-related or Procedure-related Serious Adverse Events
CEC-adjudicated safety outcomes in both arms including: * Incidence of device-related Serious Adverse Events * Incidence of embolization procedure-related Serious Adverse Events * Incidence of device-related neurological deaths or disabling strokes within 30 days of embolization procedure * Incidence of device-related Adverse Events
Time frame: 180 days post-treatment
Superiority evaluation for successful distal penetration comparing NeoCast arm to the Onyx LES active comparator arm
Superiority evaluation for successful distal penetration comparing NeoCast arm to the Onyx LES active comparator arm
Time frame: Peri-procedural
Superiority evaluation for successful embolization comparing NeoCast arm to the Onyx LES active comparator arm
Superiority evaluation for successful embolization comparing NeoCast arm to the Onyx LES active comparator arm
Time frame: 90 days post-treatment
Superiority evaluation of complete hematoma resolution at 180 days comparing the NeoCast arm to the Onyx LES active comparator arm
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Superiority evaluation of complete hematoma resolution at 180 days comparing the NeoCast arm to the Onyx LES active comparator arm
Time frame: 180 days post-treatment
Superiority evaluation of percent hematoma volume reduction at 30 days compared to post-treatment timepoint comparing the NeoCast arm to the Onyx LES active comparator arm
Superiority evaluation of percent hematoma volume reduction at 30 days compared to post-treatment timepoint comparing the NeoCast arm to the Onyx LES active comparator arm
Time frame: 30 days post-treatment