The CHALLENGER Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-98
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-98 years inclusively

Unilateral convexity cSDH measuring at least 10 mm in thickness OR

Bilateral cSDH if only one side is considered for treatment and the contralateral side is asymptomatic and < 5 mm in thickness.

cSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying cSDH

Disqualifiers

Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor

Bilateral cSDH with unknown origin of symptoms

Participants who underwent prior embolization of either MMA

Tentorial or interhemispheric SDH

Trial design

Treatments tested in this trial

  • Numen SILK coil embolization system

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

MicroPort NeuroTech Co., Ltd.

Collaborator