The CHALLENGER Registry

Not yet recruiting

• Conditions: Chronic Subdural Hemorrhage (cSDH)

• Registration Number: NCT07197840
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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 (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.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2026-03-01
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization	180 days	The proportion of patients centrally deemed to need rescue surgery or die within 180 days of MMA coil embolization

Secondary Outcome Measures

Name	Time	Method
Recurrent or residual chronic subdural hematoma measuring greater than 10 mm in thickness	180 days	Recurrent or residual chronic subdural hematoma at 180 days measuring greater than 10 mm in thickness
Number of patients requiring reoperation or surgical rescue within	180 days	Number of patients requiring reoperation or surgical rescue within 180 days
Worsening of or death from neurological causes within 180 days	180 days	Worsening of or death from neurological causes within 180 days
Major disabling stroke from neurological causes within 180 days	180 days	Major disabling stroke from neurological causes within 180 days
Rate of serious adverse events from neurological causes within 180 days	180 days	Rate of serious adverse events from neurological causes within 180 days
Change in hematoma thickness	Baseline, at 90 days and at 180 days	Change in hematoma thickness from baseline to the repeat scan at 90 days and from baseline to the repeat scan at 180 days
Modified Rankin Scale (mRS) score at 90 days and at 180 days	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.
Number of target MMA injuries related to study device	180 days	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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States