The CHALLENGER Registry
ConditionChronic Subdural Hematoma
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
This trial does not accept healthy volunteersQualifiers
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 population
The patient population for this study will be comprised of up to 100 patients with chronic subdural hematoma (cSDH).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Numen SILK coil embolization system
DeviceThe 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Numen SILK1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
Number of patients requiring reoperation or surgical rescue within
Number of patients requiring reoperation or surgical rescue within 180 days
Time frame
180 days3
Worsening of or death from neurological causes within 180 days
Worsening of or death from neurological causes within 180 days
Time frame
180 days4
Major disabling stroke from neurological causes within 180 days
Major disabling stroke from neurological causes within 180 days
Time frame
180 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
MicroPort NeuroTech Co., Ltd.
Collaborator
Source ClinicalTrials.gov