The CHALLENGER Registry

The study is a multi-center prospective, single-arm, post-market study evaluating the efficacy and radiologic and functional outcomes associated use of the Numen SILK coils for Middle Meningeal Artery (MMA) embolization following Chronic Subdural Hematoma (cSDH) compared to surgical evacuation or medical management alone. Chronic subdural hematoma is a collection of blood between the dural mater and the brain. It typically develops over time in older adults or people on anticoagulant medication. Blood slowly accumulates over time and often becomes encapsulated by a fibrous membrane over weeks or months, which can lead to the gradual development of symptoms. Middle Meningeal Artery embolization (MMAE) through coiling provides a minimally invasive option for cSDH treatment and prevention of reaccumulation and recurrence.

NCT Number	NCT07197840
Lead Sponsor	Icahn School of Medicine at Mount Sinai Collaborators: MicroPort NeuroTech Co., Ltd.
Conditions	Chronic Subdural Hematoma
Enrollment	100 participants
Start Date	2025-11-20
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-28