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
Sponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
MicroPort NeuroTech Co., Ltd.
Collaborator