The CHALLENGER Registry

NCT07197840 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY-25-00525
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hemorrhage (cSDH)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization

  The proportion of patients centrally deemed to need rescue surgery or die within 180 days of MMA coil embolization

  180 days

Secondary Outcomes (8)

• Recurrent or residual chronic subdural hematoma measuring greater than 10 mm in thickness

  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

• Major disabling stroke from neurological causes within 180 days

  180 days

• Rate of serious adverse events from neurological causes within 180 days

  180 days

Study Arms (1)

Numen SILK

Patients treated with the Numen SILK coil embolization system

Device: Numen SILK coil embolization system

Interventions

Numen SILK coil embolization system DEVICE

The Numen SILK coil embolization system is designed to be used in conjunction with the NumenFR detachment system. It consists of two main parts: • Introducer Sheath: The purpose of this sheath is to facilitate the introduction of the coil into the microcatheter. • Coil System: Composed of the pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. 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

Numen SILK

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population for this study will be comprised of up to 100 patients with chronic subdural hematoma (cSDH).

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• MicroPort NeuroTech Co., Ltd.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Shahram Majidi

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukaina Davdani

CONTACT

(212) 241-2524; Sukaina.Davdani@mountsinai.org

Samantha St Elin

CONTACT

(212) 241-2524; Samantha.StElin@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)