The CHALLENGER Registry
Recruitment Status: Recruiting
Start Date: November 20, 2025
End Date: March 01, 2028
- 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 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
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Conditions:
- Hematoma, Subdural, Chronic