NCT07197840 · Icahn School of Medicine at Mount Sinai
The CHALLENGER Registry
(CHALLENGER)
What this study is about
The study is a multi-center forward-looking, single-treatment group$1, post-market study evaluating the effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
Numen SILK coil embolization system
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
Primary outcome measures
Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization
Time frame: 180 days
The proportion of patients centrally deemed to need rescue surgery or die within 180 days of MMA coil embolization
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 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
- 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
Where
- New York, New York
Collaborators
MicroPort NeuroTech Co., Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations