The CHALLENGER Registry

Recruiting now

Conditions studied: Chronic Subdural Hematoma

In brief

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.

Key facts

Study ID

NCT07197840

Run by

Icahn School of Medicine at Mount Sinai

People needed

100

Starts

2025-11-20

Expected to finish

2028-03-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 98. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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