Evaluating Coil Embolization for Chronic Subdural Hematoma in a Multi-Center Registry

Introduction/Purpose Chronic subdural hematoma (cSDH) is a common neurosurgical condition with significant recurrence rates following conventional surgical evacuation. Recent successes in randomized controlled trials have promoted the utility of middle meningeal artery embolization (MMAE) as a promising adjunct or alternative therapy. While liquid and particulate embolic agents have been widely studied, real‐world data on coil embolization in this setting remains limited. Given the prospective advantages of coil embolization including: technical simplicity, mitigated risk of non‐target embolization, and feasibility of decreased anesthesia needs, additional studies on coils as an embolic agent in this setting are warranted. The iCURE CSDH registry is a prospective, multi‐center, single arm, post‐market clinical registry enrolling adult patients diagnosed with cSDH who undergo MMAE with Kaneka iED coils as a standalone embolic. Materials/Methods The registry will be conducted at up to 20 sites and enroll up to 200 patients (≥18 years) with symptomatic, cSDH (≤50% acute blood) requiring unilateral intervention. Patients must have a pre‐morbid Modified Rankin Score (mRS) of 0‐3 and a Markwalder Grading Scale of 0‐2. Patients may have burr hole, mini craniotomy (<3 cm), or subdural evacuation portal system (SEPS) placement at the discretion of the treating physician.Key data elements include: Patient demographics, medications and relevant medical history including mRS, Markwalder Grading Scale, Headache Impact Test (HIT‐6) scoreHematoma characteristics and CT imaging findingsProcedural details (anesthesia, embolic penetration depth within vasculature)Peri‐procedural complicationsFollow‐up imaging and clinical outcomes at 24 hours, hospital discharge/5 days, 30 days, 90 days, and 180 days. Results (Anticipated) : For comparison, both the primary and secondary effectiveness and safety outcomes are modeled to reflect recent publications on the use of alternative embolic materials in similar clinical settings. All results will be analyzed and adjudicated by an independent core‐lab. The primary effectiveness outcome will be the incidence of hematoma recurrence or progression requiring repeat MMAE or surgical reintervention within 180 days post‐procedure. The primary safety outcome will be assessed by comparing changes in functional status, as measured by mRS, at 90 days post‐procedure. Secondary outcomes include incidence of hospital readmissions, change in hematoma thickness, change in midline shift, change in mRS, change in headache intensity (via HIT‐6 score), and incidence of device and procedure‐related adverse events within 30‐180 days post‐procedure. Additional analyses will examine procedural success, stratified by the degree of coil penetration within the middle meningeal artery, to explore potential correlations between embolization depth and clinical outcomes. Anticipated results will provide insight into the clinical utility of coils for MMAE, including recurrence rates, safety profile, and functional outcomes. It will also inform best practices and support future comparative studies with other embolic modalities. Conclusion The iCURE CSDH registry represents an initial prospective effort to generate high‐quality, real‐world evidence on coil‐based MMAE for cSDH. By fostering multicenter collaboration, the registry aims to address a current gap in literature by providing quality data on both the utility and potential advantages of coil embolization in this evolving therapeutic space.