MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
ConditionSubdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorArsenal Medical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Diagnosed with acute SDH
Participant with prior embolization of either MMA
Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
Participant with bilateral SDH where both sides require surgery or contralateral SDH >5mm in greatest thickness
Trial design
Design model
Parallel
Treatments tested in this trial
NeoCast Embolic System
DeviceNeoCast 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
DeviceOnyx 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
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: NeoCast Embolic SystemExperimental treatment 1 intervention
Group B: Onyx LES FDA-Approved Commercial Liquid EmbolicActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-treatment2
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-treatmentSecondary outcomes
1
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-procedural2
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-treatment3
Superiority evaluation of complete hematoma resolution at 180 days comparing the NeoCast arm to the Onyx LES active comparator arm
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-treatment4
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-treatmentSponsors and contacts
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Source ClinicalTrials.gov