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.
The NumenFR detachment system is a sterile, handheld, single-patient use device designed for use with the Numen SILK coil embolization system and is operated by two pre-loaded batteries. The analysis of the Numen SILK coil embolization system will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the study will receive supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to: neurointensive care, neuromonitoring, and surgical and medical management of cSDH.
Study Type
OBSERVATIONAL
Enrollment
100
The Numen SILK coil embolization system is designed to be used in conjunction with the NumenFR detachment system. It consists of two main parts: • Introducer Sheath: The purpose of this sheath is to facilitate the introduction of the coil into the microcatheter. • Coil System: Composed of the pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The NumenFR detachment system is a sterile, handheld, single-patient use device designed for use with the Numen SILK coil embolization system and is operated by two pre-loaded batteries
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization
The proportion of patients centrally deemed to need rescue surgery or die within 180 days of MMA coil embolization
Time frame: 180 days
Recurrent or residual chronic subdural hematoma measuring greater than 10 mm in thickness
Recurrent or residual chronic subdural hematoma at 180 days measuring greater than 10 mm in thickness
Time frame: 180 days
Number of patients requiring reoperation or surgical rescue within
Number of patients requiring reoperation or surgical rescue within 180 days
Time frame: 180 days
Worsening of or death from neurological causes within 180 days
Worsening of or death from neurological causes within 180 days
Time frame: 180 days
Major disabling stroke from neurological causes within 180 days
Major disabling stroke from neurological causes within 180 days
Time frame: 180 days
Rate of serious adverse events from neurological causes within 180 days
Rate of serious adverse events from neurological causes within 180 days
Time frame: 180 days
Change in hematoma thickness
Change in hematoma thickness from baseline to the repeat scan at 90 days and from baseline to the repeat scan at 180 days
Time frame: Baseline, at 90 days and at 180 days
Modified Rankin Scale (mRS) score at 90 days and at 180 days
Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. The scale runs from 0-6, running from perfect health without symptoms to death: * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead.
Time frame: at 90 days and at 180 days
Number of target MMA injuries related to study device
The number of injuries to the target middle meningeal artery (MMA) that are determined to be related to the study device, as identified through adverse event reporting during the study period.
Time frame: 180 days
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