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MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

Study acronym: RADIANT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Jul 2026 to Aug 13, 2026
    • Eligibility criteria expanded, about 24 words
    • Site details revised at 2 of 2 sites
    • Publications: 1 to 2
  2. Primary endpoint(s) modifiedv2 Show 7 more changesShow less
    • Enrollment increased: 150 → 360 participants
    • Primary completion pushed from Nov 2027 to Jan 2028
    • Study completion pushed from Feb 2028 to Apr 2028
    • Interventions: FDA-Approved Commercial Liquid Embolic (Device), NeoCast Embolic System (Device) to NeoCast Embolic System (Device), Onyx LES, an FDA-Approved Commercial Liquid Embolic (Device)
    • Secondary endpoints revised (4)
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07541404
Lead Sponsor Arsenal Medical, Inc.
Conditions
(from sponsor)		 Subdural Hematoma
Related terms Hematoma, Hematoma, Subdural, Hematoma, Subdural, Chronic
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov