MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

NCT07541404 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: EMBO-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subdural Hematoma

Keywords

Hematoma; Chronic subdural hematoma (cSDH); Subacute subdural hematoma; Subdural hematoma (SDH); Middle Meningeal Artery (MMA) Embolization

Outcome Measures

Primary Outcomes (2)

• Comparison of NeoCast arm vs. FDA-approved commercial liquid embolic for demonstration of successful embolization of the middle meningeal artery

  Comparison of NeoCast arm vs. FDA-approved commercial liquid embolic for demonstration of successful embolization of the middle meningeal artery which is defined by meeting all the following criteria: * Distribution of the embolic material in the distal 50% of the MMA branches (assessed by a blinded, independent Imaging Core Lab); * Avoidance of SDH recurrence/progression requiring ipsilateral surgical drainage through 90 days (CEC adjudicated); * Avoidance of neurological disabling SAE related to the device and/or embolization procedure through 30 days (CEC adjudicated)

  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

  180 days post-treatment

Secondary Outcomes (4)

• Superiority evaluation for successful distal penetration comparing NeoCast arm to the active comparator arm

  Peri-procedural

• Superiority evaluation for successful embolization comparing NeoCast arm to the active comparator arm

  90 days post-treatment

• Superiority evaluation of complete hematoma resolution at 180 days comparing the NeoCast arm to the active comparator arm

  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 active comparator arm

  30 days post-treatment

Study Arms (2)

NeoCast Embolic System

EXPERIMENTAL

Participants randomized to the NeoCast arm will have their MMA embolized with NeoCast adjunctive to surgery

Device: NeoCast Embolic System

FDA-Approved Commercial Liquid Embolic

ACTIVE COMPARATOR

Participants randomized to the active comparator control arm will have their MMA embolized with an FDA-approved commercial liquid emblic adjunctive to surgery

Device: FDA-Approved Commercial Liquid Embolic

Interventions

NeoCast Embolic System DEVICE

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

NeoCast Embolic System

FDA-Approved Commercial Liquid Embolic DEVICE

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

Also known as: Active Comparator Arm

FDA-Approved Commercial Liquid Embolic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Legally Authorized Representative/Person Responsible for consenting on their behalf understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
• Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;
• Participant is willing to return to the investigational site for follow-up visits.

You may not qualify if:

• 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
• Participant identified with potentially dangerous anatomic variations leading to increased procedural risk, risk of incomplete embolization, or unsafe access for MMA embolization (i.e., MMA originating from ophthalmic artery)
• Participant who presents with a meningioma ≥1 cm or \< 1 cm with mass effect
• Subjects with conditions placing them at high-risk for ischemic stroke who cannot be taken off anticoagulants for at least 7 days post-surgery
• Participant currently undergoing radiation therapy for carcinoma or sarcomas of the head or neck region
• SDH developed due to underlying condition or structure pathology (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt, spontaneous intracranial hypotension or previous craniotomy)
• Presumed microbial superinfection
• Participant who is breastfeeding
• Participant with life expectancy of \<1 year
• Participants with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy
• Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
• Participant is allergic to any of the materials used in the NeoCast device or commercial embolic device

Sponsors & Collaborators

• Arsenal Medical, Inc.: lead

Study Sites (2)

Yale Neurosciences Institute

New Haven, Connecticut, 06519, United States

Location

University of Washington Medicine - Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Pham QP, Groom JV 2nd, Sadasivan C, Fiorella DJ, Madoff DC, Guo LJ, Fornaciari M, Guertin C, Wiltsey C, Core L, Merlo J, Wustenberg W, Virmani R, Arthur AS, Langer RS, Whitesides GM, Sharma U. An In Situ Curing, Shear-Responsive Biomaterial Designed for Durable Embolization of Microvasculature. Adv Healthc Mater. 2025 Jun;14(15):e2404011. doi: 10.1002/adhm.202404011. Epub 2025 Mar 11.

  PMID: 40066510 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Chronic Disease; Disease Attributes

Study Officials

• Charles Matouk, MD

  Yale Neurosciences Institute

  PRINCIPAL INVESTIGATOR

• Michael Levitt, MD

  University of Washington Medicine - Harborview Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Pekar, MBA

CONTACT

508-523-5456; cpekar@arsenalmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Independent Imaging Core Lab
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)