Status:
NOT_YET_RECRUITING
The CHALLENGER Registry
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
MicroPort NeuroTech Co., Ltd.
Conditions:
Chronic Subdural Hemorrhage (cSDH)
Eligibility:
All Genders
18-98 years
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 18-98 years inclusively
- Per CT of the head, (one of the following):
- 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
- Qualifying baseline head CT performed within the 14 days prior to treatment
- Patient or legally authorized representative agrees to be participated in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Exclusion Criteria:
- 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
- mRS \>4
- On tranexamic acid
- Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \[INR\] \> 1.5 and/or platelet count \< 80109/L)
- Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA ophthalmic artery anastomosis)
- Known contraindications to angiography
- Known intolerance to occlusion procedures
- Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or coil embolization
- Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
- Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.
- Patient has a known active systemic infection or sepsis
- Patient is pregnant, planning to become pregnant, or lactating
- Life expectancy of less than 6 months due to comorbid terminal conditions
- Concurrent participation in another research protocol for investigation of an experimental therapy
- Known or suspected to not be able to comply with the study protocol
Exclusion
Key Trial Info
Start Date :
March 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07197840
Start Date
March 1 2026
End Date
March 1 2028
Last Update
September 29 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029