Yoo AJ, Geyik S, Froehler MT, Maurer CJ, Kass-Hout T, Zaidat OO, Nogueira RG, Hanel RA, Pierot L, Spelle L, Lopes D, Hassan A, Širvinskas A, Lin E, Ribo M, Blasco J, Taqi MA, Badruddin A, Siddiqui AH, Miller TR, Hussain SM, Haussen DC, Woodward K, Groden C, Consoli A, Chaudry MI, Ramsey C, Maud A, Bentley J, Bajrami A, Sahnoun M, Fiehler J, and Gupta R
Background: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval., Objective: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device., Methods: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH)., Results: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139)., Conclusions: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal., Trial Registration Number: NCT04514562., Competing Interests: Competing interests: AJY: consultant: Penumbra, Cerenovus, Vesalio, Zoll Circulation, Philips Neurovascular; individual stocks/stock options: Nicolab; ownership interest: Insera Therapeutics, Galaxy Therapeutics; research funding (principal investigator (PI) or named investigator): Medtronic, Cerenovus, Penumbra, Stryker, Genentech. LS: consultant: Balt, Medtronic, Microvention, Stryker; research funding (PI or named investigator): Philips. AH: consultant: Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care. AS: consultant: Microvention, Stryker, Vesalio. AHS: consultant: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., Cerenovus, Cerevatech Medical, Inc; inidividual stocks/stock options: Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd., BlinkTBI, Inc, Borvo Medical, Inc., Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, Collavidence, I; other; Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial; CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, Research Funding (PI or named investigator); co-investigator for NIH - 1R01EB030092-01, Project Title: High speed angiography at 1000 frames per second; Mentor for Brain Aneurysm Foundation Carol W. Harvey Chair of Research, Sharon Epperson Chai. SG: Consultant; Stryker, Microvention, Medtronic. TRM: Advisor; Carpl AI. MTF: advisor; Cerenovus; research funding (PI or named investigator): Medtronic Neurovascular; researcher: Stryker Neurovascular, Cerenovus, Rapid Medical. DCH: consultant; Stryker Neurovascular, Cerenovus, Chiesi USA, Brainomix, Poseydon Medical; individual stocks/stock options: VizAI and Motif; other: Jacobs Institute/Medtronic, Vesalio., Frontiers in Neurology. MIC: advisor: Celt/Vasorum; consultant: Microvention, Medtronic, Imperative Care, Q'Apel; individual stocks/stock options: Imperative Care, Celt/Vasorum, Synchron, Endostream, Cerebrotech, Q'Apel, RIST, Three Rivers Medical, Neuolutions, Radical Medical, Tulavi, viseon, VMT, Vastrax, Serenity Medical. MF: consultant: Cerenovus, Balt, Jacobs Institute, Kai Medical, Oculus; research funding (PI or named investigator): Vesalio, Genentech, Siemens. MS: consultant: Vesalio., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)