The CHALLENGER Registry (NCT07197840) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The CHALLENGER Registry
United States100 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 98 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 arter…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization