LB-002 Core lab and clinical outcome adjudicated results of M2 aspiration thrombectomy: a subgroup analysis from the imperative trial
Year: 2025
Type: conference-abstract
Abstract: Introduction Recent trials (ESCAPE-MeVO and DISTAL) failed to demonstrated superiority of endovascular thrombectomy (EVT) for medium and small vessel occlusions compared to medical management (MM). Potential limitations of these trials include an older patient population, milder presenting National Institutes of Health Stroke Scale (NIHSS), a higher proportion of patients with premorbid disability, longer intervals from presentation to revascularization, inclusion of both medium and small vessel occlusions in the same study, and a very high percentage of patients being treated with stent retrievers (SRs). Here we present M2 occlusion data from the prospective Imperative Trial (IT) evaluating the Zoom System for aspiration thrombectomy. Methods The IT is a prospective, multicenter, single-arm core lab and independent safety board adjudicated trial evaluating the Zoom System (Imperative Care, Inc., Campell, California) for intracranial large vessel and M2 occlusion. In this sub-analysis, patients with core lab adjudicated M2 occlusions were identified and their data summarized for evaluation. Good and excellent angiographic outcomes were defined as final reperfusion mTICI≥2b and mTICI ≥2c, respectively. Good and excellent clinical outcome were defined as mRS 0-2 and 0-1 at 90 days, respectively. Safety was evaluated by all-cause mortality, symptomatic intracranial hemorrhage (sICH) and all hemorrhage. Results Of the 260 patients prospectively enrolled in the IT, 25% (65/260) presented with primary M2 occlusions and were included in this analysis. The median age was 69 (IQR 57.5-79.5) years with a median presenting NIHSS of 13 (IQR 10.3-17). Good and excellent reperfusion was 88% (57/65) and 66% (43/65), respectively. Good and excellent clinical outcomes at 90 days occurred in 62% (39/63) and 56% (35/63) of patients, respectively. All-cause mortality, sICH, and all hemorrhage were 4.6% (3/65), 1.5% (1/65), and 18.5% (12/65), respectively. These outcomes compared favorably with the EVT and MM arms of both ESCAPE-MeVO and Distal (table 1). Conclusions M2 occlusions in the IT presented with higher NIHSS in younger patients than observed in recent MeVO trials. Results demonstrated excellent angiographic, clinical, and safety outcomes when treated with the Zoom Reperfusion System. These data suggest that excellent safety and clinical outcomes can be achieved with aspiration thrombectomy, despite significant presenting deficits in an M2 occlusion population. Future randomized trials for medium vessel occlusions are warranted. Disclosures J. Mascitelli: 2; C; Stryker, Imperative Care. R. De Leacy: 2; C; Hyprevention, Imperative Care, J&J, Medical Device Business Services, Scientia Vascular, Stryker. 4; C; Endostream, Q’Apel, Spartan Micro, Synchron, Van Vascular, Vastrax. W. Mack: 2; C; Egret, Imperative Care, Integra LifeSciences, Q’Apel, Rebound Therapeutics, Spartan Micro, Stream Biomedical, Stryker, Viseon. 4; C; Borvo, Cerebrotech, Egret, Endostream, Q’Apel, Radical Catheters, Rebound Therapeutics, Spartan Micro, Stream Biomedical, Vastrax, Viseon. R. Nogueira: 2; C; Stryker, Cerenovus, Medtronic, Phenox, Anaconda, Genentech, Biogen, Prolong Pharmaceuticals, Imperative Care. 4; C; Brainomix, Viz-AI, Corindus Vascular Robotics, Vesalio, Ceretrieve, Astrocyte, Cerebrotech. S. Majidi: 2; C; DePuy Synthes, Imperative Care, Medical Device Business Services, Rapid Medical. D. Tomalty: 2; C; Imperative Care. 3; C; Inari Medical. M. Mokin: 1; C; NIH. 2; C; Balt USA, Canon Medical, Imperative Care, J&J, Medtronic, MicroVention, Rapid Pulse. 4; C; Bendit Technology, Borvo Medical, Brain Q, Endostream, QAS.AI, Quantanosis.AI, Radical Catheter Technologies, Serenity Medical, Sim&Cure, Synchrone, VICIS. J. Vargas: 2; C; Viz.AI, Imperative Care, Precision Neuro, Q’Apel, Medtronic, Microvention. 4; C; Viz.AI, Imperative Care, Borvo, Radical, Synchron. B. Cucchiara: None. K. Snyder: 2; C; Boston Scientific, Canon Medical Systems, MicroVention, Medtronic, Stryker. 3; C; Canon Medical Systems USA Inc. 4; C; Boston Scientific, Access Closure, Niagara Gorge Medical. V. Parada: None. H. Shakir: 2; C; Imperative Care, Q’Apel Medical, Stryker, Terumo. 4; C; Borvo Medical, Cerebrotech, Radical Catheter Technologies, Sim&Cure, Synchron. D. Rosenbaum-Halevi: None. N. Aghaebrahim: 3; C; Penumbra. D. Hoit: 2; C; Imperative Care, Stryker. 3; C; Medtronic, MicroVention. B. Yim: 2; C; Penumbra, Stryker, Terumo, Q’Apel, Imperative Care, Rapid Medical. M. Tenser: None. A. Al-Bayati: 2; C; Medical Device Business Services, Stryker. J. Milburn: 2; C; Imperative Care, MicroVention. S. Nimjee: 2; C; Medical Device Business Services, Baskin Biosciences. 3; C; Medtronic. N. Haranhalli: None. M. Nahhas: None. D. Shaff: None. K. Layton: 2; C; Stryker. N. Beaty: 2; C; Stryker. R. Starke: 3; C; Medtronic, Penumbra. H. Hawk: None. D. Haussen: 2; C; Chiesi USA, DePuy Synthes, Stryker. A. Pabaney: None. C. Kellner: 1; C; Cerenovus, Medtronic. 2; C; Integra LifeSciences. J. Grossberg: 1; C; Emory Medical Care Foundation, Emory Neurosurgery Catalyst, Georgia Research Alliance, National Institute of Neurological Disorders and Stroke, Uniformed Services University-Surgical Critical Care Initiative. 2; C; Cognition, Imperative Care, NTI, Route 92.
Authors: J Mascitelli, R De Leacy, W Mack, R Nogueira, S Majidi, D Tomalty, M Mokin, J Vargas, B Cucchiara, K Snyder, V Parada, H Shakir, D Rosenbaum-Halevi, N Aghaebrahim, D Hoit, B Yim, M Tenser, A Al-Bayati, J Milburn, S Nimjee, N Haranhalli, M Nahhas, D Shaff, K Layton, N Beaty, R Starke, H Hawk, D Haussen, A Pabaney, C Kellner, J Grossberg
Institutions: The University of Texas at San Antonio Health Science Center, Icahn School of Medicine at Mount Sinai, University of Southern California, Keck Hospital of USC, UPMC Health System, University of Pittsburgh Medical Center, Huntsville Hospital, University of South Florida, Prisma Health, University of Pennsylvania, University at Buffalo, State University of New York, Valley Baptist Medical Center, University of Oklahoma Health Sciences Center, Munson Medical Center, Baptist Medical Center Jacksonville, University of Tennessee Health Science Center, John Muir Health, John Muir Medical Center, Ochsner Health System, Ochsner Medical Center, The Ohio State University, Albert Einstein College of Medicine, Montefiore Medical Center, The University of Texas Health Science Center at Houston, Lehigh Valley Hospital, Baylor University Medical Center, Florida State University, University of Miami Health System, Erlanger Health System, Emory University
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4413081159