PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial

This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).

NCT Number	NCT07576998
Lead Sponsor	Microvention-Terumo, Inc.
Conditions	Chronic Subdural Hematomas
Enrollment	475 participants
Start Date	2026-12-31
Primary Completion	2030-05-31 (estimated)
Study Completion	2031-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-08