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A101 Middle meningeal artery embolisation for treatment of chronic subdural hematoma (cSDH) with trufill n-BCA: membrane trial primary results

neurintsurg · 2025-09-02 · canonical JSON source

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Introduction Endovascular embolisation of the middle meningeal artery (eMMA) with a liquid embolic is an emerging treatment for cSDH. The prospective, global, multicentre, open-label MEMBRANE study ( NCT04816591) evaluated safety/effectiveness of TRUFILL n-Butyl Cyanoacrylate (n-BCA) for eMMA in participants with cSDH versus standard-of-care (SOC).Aim of Study To present safety/effectiveness results from the MEMBRANE study.Method Site physicians assessed participants for surgical or non-surgical management. Primary effectiveness endpoint was residual or re-accumulation of the cSDH (>10mm) at 6 months or re-operation or surgical procedure on the cSDH within 6 months. Primary safety endpoint was occurrence of all adverse events (AEs) through 6 months. Percentage of participants with good functional outcome at 3 months (modified Rankin Scale [mRS] 0–2 or no worsening from baseline if baseline mRS ≥3) was assessed, along with other secondary endpoints.Results After demonstrating cSDH stability, 376 participants were randomised to receive SOC alone or SOC and TRUFILL n-BCA eMMA in each surgical/non-surgical cohort, with follow-up at 1-, 3-, 6-, and 12-months post-procedure. Statistically significant treatment benefit of using TRUFILL n-BCA versus SOC across both cohorts (with or without surgery) was demonstrated (p=0.044). eMMA treatment was successfully non-inferior to SOC alone for assessment of good functional outcome. Overall AEs were reported by 71.8% and 65.3% of participants in the eMMA and SOC groups, respectively. Secondary effectiveness, safety, and health economic outcomes generally favoured eMMA treatment versus SOC alone.Conclusion This study demonstrates a positive treatment effect of eMMA using TRUFILL n-BCA versus SOC, with a safety profile comparable to SOC.Conflict of Interest Yes Christopher P. Kellner: Research at Mount Sinai supported by research grants from: Integra LifeSciences, Penumbra, Viz.ai, Siemens, Medtronic, Longeviti, IRRAS, iCE Neurosystems, CVAID, EndoStream, MicroTransponder; consultant for Route 92 Medical and Johnson & Johnson MedTech Neurovascular, with compensation to Mount Sinai for his time; and equity in Precision Recovery, Borealis, E8, Borvo, and METIS Innovative (METIS Innovative is an investment group that has coordinated investments in Synchron, Proprio, Fluid Biomed, VonVascular.io, Precision Recovery, Phantom Neuro, Radical, Aurenar, and Reach Neuro). Ansaar T. Rai: Consulting fees from Johnson & Johnson MedTech Neurovascular and Stryker. Hazem Shoirah: None. Visish M. Srinivasan: Consulting fees from Johnson & Johnson MedTech Neurovascular, Stryker, Imperative Care, IschemaView, and the National Football League. Grants from Zeiss, Medtronic, Stryker, and Siemens. Rishi Gupta: Steering committee for MEMBRANE study sponsored by Johnson & Johnson MedTech Neurovascular and ELEVATE study sponsored by Medtronic; principal investigator for DISTALS study sponsored by Rapid Medical, RECCLAIM II sponsored by ZOLL Medical, and ASSIST registry sponsored by Stryker Neurovascular; and Clinical Events Committee for MIND study sponsored by Penumbra. Robert M. Starke: Research supported by the Neurosurgery Research & Education Foundation, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, Department of Health Biomedical Research Grant (21K02AWD-007000), and by National Institute of Health (R01NS111119–01A1 and UL1TR002736, KL2TR002737) through the Miami Clinical and Translational Science Institute, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities; unrestricted research grant from Medtronic and Balt Group; and consulting and teaching agreements with Penumbra, Abbott, Medtronic, Balt Group, InNeuroCo, Johnson & Johnson MedTech Neurovascular, Microvention, Stryker, Zylox-Tonbridge, VON Medical, and Optimize Vascular. Fawaz Al-Mufti: Consulting fees from Stryker Neurovascular, Johnson & Johnson MedTech Neurovascular, and Rapid AI. Charles Matouk: Consulting fee or speakers bureau for Stryker, Medtronic, Microvention, Penumbra, and Silk Road Medical; research funding from NIH (Contact PI for NIH Grant R21NS128641). Benjamin Yim: Consulting/speaking agreements with Imperative Care, Terumo Neuro, Penumbra, Rapid Medical, Q’Apel, Kaneka, Stryker. Matthew Fusco: None. Jieqing Wan: None. SoHyun Boo: Consulting fee or speakers bureau for Stryker, Johnson & Johnson MedTech Neurovascular, and Microvention; proctor for the WEB™ device. Brian T. Jankowitz: Consultant for Johnson & Johnson MedTech Neurovascular, Rapid Medical, Medtronic, MIVI Neurosciences, Balt, Zimmer Biomet, Stryker, and IRRAS.