Chronic Subdural Hematoma
Conditions
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.
Detailed 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.
Interventions
DEVICENumen 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
Sponsors
Icahn School of Medicine at Mount Sinai
MicroPort NeuroTech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 98 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization | 180 days | The proportion of patients centrally deemed to need rescue surgery or die within 180 days of MMA coil embolization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent or residual chronic subdural hematoma measuring greater than 10 mm in thickness | 180 days | Recurrent or residual chronic subdural hematoma at 180 days measuring greater than 10 mm in thickness |
| Number of patients requiring reoperation or surgical rescue within | 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 | Worsening of or death from neurological causes within 180 days |
| Major disabling stroke from neurological causes within 180 days | 180 days | Major disabling stroke from neurological causes within 180 days |
| Rate of serious adverse events from neurological causes within 180 days | 180 days | Rate of serious adverse events from neurological causes within 180 days |
| Change in hematoma thickness | Baseline, at 90 days and at 180 days | Change in hematoma thickness from baseline to the repeat scan at 90 days and from baseline to the repeat scan at 180 days |
| Modified Rankin Scale (mRS) score at 90 days and at 180 days | at 90 days and at 180 days | Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. The scale runs from 0-6, running from perfect health without symptoms to death: * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead. |
| Number of target MMA injuries related to study device | 180 days | The number of injuries to the target middle meningeal artery (MMA) that are determined to be related to the study device, as identified through adverse event reporting during the study period. |
Countries
United States
Contacts
CONTACTSukaina Davdani
CONTACTSamantha St Elin
PRINCIPAL_INVESTIGATORShahram Majidi
Icahn School of Medicine at Mount Sinai
Outcome results
None listed