The CHALLENGER Registry

Mount Sinai Health System

Status

Begins enrollment this month

Conditions

Chronic Subdural Hemorrhage (cSDH)

Treatments

Device: Numen SILK coil embolization system

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07197840

STUDY-25-00525

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 98 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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