MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma
ConditionSubdural Hematoma
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- NeoCast Embolic System
- Onyx LES, an FDA-Approved Commercial Liquid Embolic
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov