Chronic Subdural HematomaCHALLENGERNCT07197840
The CHALLENGER Registry
An observational study of Chronic Subdural Hematoma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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 (MMA) embolization following Chronic Subdural Hematoma (cSDH) compared to surgical evacuation or medical management… Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Numen SILK coil embolization system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to 1 Mar 2028
- How long will I take part?
- 180 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population for this study will be comprised of up to 100 patients with chronic subdural hematoma (cSDH).
Who may be able to join
None listed.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sukaina Davdani, (212) 241-2524, Sukaina.Davdani@mountsinai.org
Samantha St Elin, (212) 241-2524, Samantha.StElin@mountsinai.org
About this study
Official title: Chronic Subdural Hematoma Treated With Numen SILK Coiling of Middle Meningeal Artery
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.
Read the 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 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Numen SILK coil embolization system
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numen SILK coil embolization systemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Numen SILK | Patients treated with the Numen SILK coil embolization system Receives: Device: Numen SILK coil embolization system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 days
Secondary outcomes (8)
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
Measured: 180 days
Number of patients requiring reoperation or surgical rescue within
Number of patients requiring reoperation or surgical rescue within 180 days
Measured: 180 days
Worsening of or death from neurological causes within 180 days
Worsening of or death from neurological causes within 180 days
Measured: 180 days
Major disabling stroke from neurological causes within 180 days
Major disabling stroke from neurological causes within 180 days
Measured: 180 days
Rate of serious adverse events from neurological causes within 180 days
Rate of serious adverse events from neurological causes within 180 days
Measured: 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
Measured: 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.
Measured: 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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start20 Nov 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort NeuroTech Co., Ltd.
- Responsible party
- Principal investigator, Shahram Majidi, Icahn School of Medicine at Mount Sinai
- Investigators
- Shahram Majidi, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197840
- Sponsor's protocol ID
- STUDY-25-00525
- Acronym
- CHALLENGER
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on its cloud-based system.