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Introduction/Purpose Middle meningeal artery embolization (MMAE) with a liquid embolic is an emerging treatment for chronic subdural hematomas (cSDH). MEMBRANE ( NCT04816591) is a prospective, global, multi-center, open-label, randomized controlled trial evaluating the safety and effectiveness of TRUFILL n-Butyl Cyanoacrylate (n-BCA) for MMAE in participants with cSDH versus standard-of-care (SOC). A total of 376 subjects were enrolled across 30 sites in the US and China. Six-month results demonstrated a positive treatment effect of MMAE+SOC versus SOC for the primary effectiveness endpoint (residual or re-accumulation of hematoma (>10 mm), reoperation or surgical procedure on the cSDH), with a similar safety profile to SOC. Here we report results from the longer-term, 12-month follow-up.Materials and Methods All imaging endpoints were assessed by an independent core laboratory, and all adverse events (AEs) were adjudicated by a Clinical Events Committee (CEC). Effectiveness outcomes included requirement for surgery on cSDH within 12 months and >50% hematoma volume reduction in the Intent-to-Treat (ITT) analysis. Safety outcomes included changes in modified Rankin Scale (mRS), Markwalder Grading Scale (MGS) scores, incidence of new onset seizures per CEC, death, stroke, myocardial infarction, or thromboembolic complications per CEC, and device-related AEs in the As-Treated Population.Results Within 12 months, significantly fewer participants in the ITT analysis set (N=376) required surgery following MMAE+SOC versus SOC alone (4.3% versus 12.9%; common odds ratio, 0.390 [90% confidence interval, CI: 0.189, 0.808]; P=0.020). At 12 months, hematoma volume reduction >50% compared to baseline occurred in 99.2% (131/132) of MMAE+SOC and 97.3% (110/113) of SOC alone; complete resolution occurred in 81.8% and 72.6% of participants in the MMAE+SOC and SOC alone groups, respectively, with median times to complete resolution of 121.5 and 145.6 days. Over 12 months, Kaplan-Meier (KM) analysis showed lower probability of acute or new cSDH in MMAE+SOC compared with SOC alone over time. Rebleeding (acute or new cSDH) rates [90% CI] for MMAE+SOC versus SOC alone groups were 11.2% [7.9%, 15.8%] versus 16.7% [12.6%, 21.9%] at 12 months. In the As-Treated Population (N=371), changes in mRS and MGS scores from baseline to 12 months showed an increase in the proportion of patients with mRS scores 0-1 in both MMAE+SOC (52.0% to 64.9%) and SOC alone (56.2% to 69.2%) and in the proportion of participants with MGS score 0 in both MMAE+SOC (17.3% to 70.7%) and SOC alone (24.8% to 72.6%). KM analysis of time to new onset of seizures per CEC showed a cumulative incidence rate [90% CI] of 6.1% [3.8%, 9.9%] in MMAE+SOC and 3.2% [1.6%, 6.2%] in SOC alone at 12 months. KM analysis of death, stroke, myocardial infarction, or thromboembolic complications showed rates [90% CI] for MMAE+SOC versus SOC alone groups of 12.4% [8.8%, 17.3%] versus 11.6% [8.2%, 16.4%] at 12 months. Device-related AEs were reported for 3.9% in the MMAE+SOC group within 12 months.Conclusion The 12-month MEMBRANE study results demonstrated a positive long-term treatment effect of MMAE using TRUFILL n-BCA versus SOC for reduction in requirement for re-operation on cSDH and a safety profile similar to SOC.Disclosures A. Rai: 2; C; Johnson & Johnson MedTech Neurovascular and Stryker. 3; C; Johnson & Johnson MedTech Neurovascular and Stryker. C. Kellner: 2; C; Route 92 Medical and Johnson & Johnson MedTech Neurovascular; has received research grants from Integra LifeSciences, Penumbra, Viz.ai, Siemens, Medtronic, Longeviti, IRRAS, iCE Neurosystems, CVAID, EndoStream, and MicroTransponder. 3; C; Route 92 Medical and Johnson & Johnson MedTech Neurovascular; has received research grants from Integra LifeSciences, Penumbra, Viz.ai, Siemens, Medtronic, Longeviti, IRRAS, iCE Neurosystems, CVAID, EndoStream, and MicroTransponder. 6; C; 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). H. Shoirah: None. V. Srinivasan: 1; C; Zeiss, Medtronic, Stryker, Siemens. 2; C; Johnson & Johnson MedTech Neurovascular, Stryker, Imperative Care, IschemaView, Q’ Apel, Rapid Medical, National Football League. R. Gupta: 6; C; Received royalties from UpToDate, Johnson & Johnson MedTech Neurovascular (MEMBRANE study steering committee member), Medtronic (ELEVATE study steering committee member), Rapid Medical (PI for DISTALS study), ZOLL Medical (PI for RECCLAIM II study), Stryker Neurovascular (PI for ASSIST registry), and Penumbra (member of MIND study clinical events committee). R.M. Starke: 2; C; Penumbra, Abbott, Medtronic, Balt Group, InNeuroCo, Johnson & Johnson MedTech Neurovascular, Microvention, Stryker, Zylox-Tonbridge, VON Medical, and Optimize Vascular. 3; C; Penumbra, Abbott, Medtronic, Balt Group, InNeuroCo, Johnson & Johnson MedTech Neurovascular, Microvention, Stryker, Zylox-Tonbridge, VON Medical, and Optimize Vascular. 6; C; Neurosurgery Research & Education Foundation (research funding), Joe Niekro Foundation (research funding), Brain Aneurysm Foundation (research funding), Bee Foundation (research funding), Department o, National Institute of Health (through Miami Clinical and Translational Science Institute; Grants R01NS111119-01A1 and UL1TR002736, KL2TR002737), National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities Medtronic (unrestricted research grant) and Balt Group (unrestricted research, Medtronic (unrestricted research grant) and Balt Group (unrestricted research grant). F. Al-Mufti: 2; C; Stryker Neurovascular, Johnson & Johnson MedTech Neurovascular, and Rapid AI. 3; C; Stryker Neurovascular, Johnson & Johnson MedTech Neurovascular, and Rapid AI. C. Matouk: 2; C; Stryker, Medtronic, Microvention, Penumbra, and Silk Road Medical. 3; C; Stryker, Medtronic, Microvention, Penumbra, and Silk Road Medical. 4; C; CereVasc, Jiva Medical, and Neurofine. 6; C; NIH (received grant R21NS128641). B. Yim: 2; C; Imperative Care, Stryker, Q’Apel, Kaneka, Terumo Neuro, Rapid Medical, and Penumbra. 3; C; Imperative Care, Stryker, Q’Apel, Kaneka, Terumo Neuro, Rapid Medical, and Penumbra. 6; C; Johnson & Johnson MedTech Neurovascular (principal investigator) and Kaneka (registry data source). M. Fusco: None. J. Wan: None. E. Liptrap: None. P. Bhuva: 2; C; Johnson & Johnson MedTech Neurovascular. 3; C; Johnson & Johnson MedTech Neurovascular. R. Grandhi: 2; C; Medtronic Neurovascular, Johnson & Johnson MedTech Neurovascular, Balt Neurovascular, and Stryker Neurovascular. 3; C; Medtronic Neurovascular, Johnson & Johnson MedTech Neurovascular, Balt Neurovascular, and Stryker Neurovascular. R. Cerejo: 6; C; iSchemaView (served as a member of advisory board). J. Liu: None. J. Cherian: None. Q. Zhang: None. I. Kaminsky: 2; C; Johnson & Johnson. C. Prestigiacomo: 6; C; Served on an advisory panel for Imperative Care and Penumbra. E. Orru’: 2; C; Stryker Neurovascular, Balt, Kaneka, Johnson & Johnson MedTech, and Philips. E. Lin: None. J. Howington: 2; C; Johnson & Johnson MedTech. A. Evans: None. T. Mehta: 1; C; PCORI. 2; C; Johnson & Johnson, Terumo, Balt, and Medtronic. S. Boo: None. I. Finch: None. T. Liu: None. R.V. Chitale: 1; C; Cerenovus and Kaneka. 6; C; Participated in a clinical events committee for Medtronic and Galaxy Therapeutics, participated on a data safety monitoring board for the DISH trial, participated in the steering committee for the PLUNGER Stroke trial, and is a co-founder/owner of Perceptive Robotics, Inc. S. Majidi: 2; C; JNJ, Imperative Care, Rapid Medical, and Kaneka. 6; C; Advisory board for JNJ, Imperative Care, Rapid Medical, and Kaneka. B. Jankowitz: 2; C; Johnson & Johnson MedTech Neurovascular, Medtronic, Balt, and Stryker. 3; C; Johnson & Johnson MedTech Neurovascular, Medtronic, Balt, and Stryker.