Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-03-01
2028-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Numen SILK
Patients treated with the Numen SILK coil embolization system
Numen SILK coil embolization system
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
Interventions
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Numen SILK coil embolization system
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
Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
98 Years
ALL
No
Sponsors
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MicroPort NeuroTech Co., Ltd.
INDUSTRY
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Shahram Majidi
Associate Professor of Neurosurgery
Principal Investigators
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Shahram Majidi
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY-25-00525
Identifier Type: -
Identifier Source: org_study_id
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