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Subdural HematomaRADIANTNCT07541404

MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

A study testing NeoCast Embolic System and Onyx LES, an FDA-Approved Commercial Liquid Embolic in people with Subdural Hematoma, run by Arsenal Medical, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Subdural Hematoma
What is being tested?
NeoCast Embolic System and Onyx LES, an FDA-Approved Commercial Liquid Embolic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesUnited States
Study dates
13 Aug 2026to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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 the Onyx LES commercial embolic device
  • Participant who is currently participating or planning to participate within 6 months in another clinical research study

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carol Pekar, MBA contact

508-523-5456

cpekar@arsenalmedical.com

United States2 sites, 2 recruiting

  • Yale Neurosciences Institute

    New Haven, Connecticut, 06519

    Not yet recruiting

  • University of Washington Medicine - Harborview Medical Center

    Seattle, Washington, 98104

    Recruiting

Other trials in United States

About this study

Official title: Pivotal Study of the Treatment of Symptomatic Subacute and Chronic Subdural Hematoma Via Middle Meningeal Artery Embolization With the NeoCastTM Embolic System (RADIANT)

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.

Read the detailed 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. 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.

Being tested
NeoCast Embolic System, Onyx LES, an FDA-Approved Commercial Liquid Embolic
Keywords
Hematoma, Chronic subdural hematoma (cSDH), Subacute subdural hematoma, Subdural hematoma (SDH), Middle Meningeal Artery (MMA) Embolization
Medical subject headings
Hematoma, Subdural, Hematoma, Hematoma, Subdural, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeoCast Embolic SystemDevice

    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 EmbolicDevice

    Also called Active Comparator Arm

    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

Study groups in NCT07541404
Study groupRoleWhat they receive
NeoCast Embolic SystemExperimentalParticipants randomized to the NeoCast arm will have their MMA embolized with NeoCast adjunctive to surgery
Receives: Device: NeoCast Embolic System
Onyx LES FDA-Approved Commercial Liquid EmbolicActive comparatorParticipants randomized to the active comparator control arm will have their MMA embolized with Onyx LES, an FDA-approved commercial liquid embolic adjunctive to surgery
Receives: Device: Onyx LES, an FDA-Approved Commercial Liquid Embolic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 90 Days post-treatment

  2. 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

    Measured: 180 days post-treatment

Secondary outcomes (4)

  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

    Measured: Peri-procedural

  2. 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

    Measured: 90 days post-treatment

  3. 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

    Measured: 180 days post-treatment

  4. 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

    Measured: 30 days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start13 Aug 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07541404
Sponsor's protocol ID
EMBO-03
Acronym
RADIANT
Status last verified
Sep 2026
First submitted
6 Apr 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Slater LA, de Villiers L, Arthur AS, Groom J 2nd, Pham QP, Pekar C, Fiorella D. A first-in-human, prospective feasibility trial of a next-generation, shear-responsive, liquid embolic biomaterial, NeoCast. J Neurointerv Surg. 2026 Sep 7:jnis-2026-025708. doi: 10.1136/jnis-2026-025708. Online ahead of print.

    PubMed 42567700

  • 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.

    PubMed 40066510

Questions about this trial

What is this clinical trial studying?

A study testing NeoCast Embolic System and Onyx LES, an FDA-Approved Commercial Liquid Embolic in people with Subdural Hematoma, run by Arsenal Medical, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carol Pekar, MBA (508-523-5456, cpekar@arsenalmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of NeoCast arm vs. Onyx LES arm for a composite endpoint of treatment failure events (time frame: 90 Days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07541404, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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