{
  "abstract": "Background Mechanical thrombectomy is the standard of care for large vessel occlusion (LVO) stroke, yet most device trials focus on individual technologies rather than complete systems.Objective To evaluate the safety and efficacy of the Zoom Reperfusion System compared with performance goals derived from a meta-analysis of trials using established thrombectomy technologies.Methods Prospective, multicenter, non-randomized, investigational device exemption trial conducted across 26 United States centers from October 2021 to March 2024. Adults with anterior circulation LVO stroke within 8 hours of onset were treated using the Zoom System, which includes aspiration catheters ranging from 0.035″ to 0.071″, and a novel 0.088″ intracranial guide/aspiration catheter. The primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3) within three passes using Zoom-only components, adjudicated by an independent core laboratory. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Secondary outcomes included final reperfusion, first-pass success, time to reperfusion, 90-day modified Rankin Scale (mRS), and mortality.Results Among 260 patients (median age 68 years; median National Institutes of Health Stroke Scale (NIHSS) 15), successful reperfusion within three passes was achieved in 83% (216/259; 95% CI: 78% to 89%), exceeding the performance goal (p<0.001). Final reperfusion was 92%, with 5.5% requiring rescue devices. First-pass mTICI 2b-3 success was 57%. Median puncture-to-reperfusion time was 19 min. At 90 days, 55% achieved mRS 0–2. The sICH rate was 1.9%, and 90-day mortality was 12.7%.Conclusions The Zoom Reperfusion System demonstrated a safety and efficacy profile exceeding prespecified contemporary performance metrics with potential to significantly shorten reperfusion times and reduce the need for rescue therapy.Trial registration number ClinicalTrials.gov--Identifier: NCT04129125.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurosurgery, USC Keck School of Medicine, Los Angeles, California, USA"
      ],
      "name": "William Mack"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Reade Andrew De Leacy"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Radiology, and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA"
      ],
      "name": "Jonathan A Grossberg"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Shahram Majidi"
    },
    {
      "affiliations": [
        "Huntsville Hospital, Huntsville, Alabama, USA"
      ],
      "name": "Robert Dana Tomalty"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA"
      ],
      "name": "Maxim Mokin"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA"
      ],
      "name": "Jan Vargas"
    },
    {
      "affiliations": [
        "Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Brett L Cucchiara"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA"
      ],
      "name": "Kenneth V Snyder"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA"
      ],
      "name": "Justin Mascitelli"
    },
    {
      "affiliations": [
        "Department of Neurology, Valley Baptist Medical Center, Harlingen, Texas, USA",
        "Department of Neurology, The University of Texas Rio Grande Valley, Brownsville, Texas, USA"
      ],
      "name": "Victoria Parada"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA"
      ],
      "name": "Hakeem J Shakir"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Munson Medical Center, Traverse City, Michigan, USA"
      ],
      "name": "David Rosenbaum-Halevi"
    },
    {
      "affiliations": [
        "Baptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA"
      ],
      "name": "Amin Aghaebrahim"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA",
        "Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee, USA"
      ],
      "name": "Daniel Hoit"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, John Muir Health, Walnut Creek, California, USA"
      ],
      "name": "Benjamin Yim"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of Southern California, Los Angeles, California, USA"
      ],
      "name": "Matthew S Tenser"
    },
    {
      "affiliations": [
        "Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA"
      ],
      "name": "Alhamza R Al-Bayati"
    },
    {
      "affiliations": [
        "Department of Radiology, Ochsner Medical Center, New Orleans, Louisiana, USA"
      ],
      "name": "James M Milburn"
    },
    {
      "affiliations": [
        "Department of Neurological Surgery, Ohio State University, Columbus, Ohio, USA"
      ],
      "name": "Shahid M Nimjee"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Montefiore Hospital and Medical Center, New York, New York, USA",
        "Department of Neurosurgery, Albert Einstein College of Medicine, New York, New York, USA"
      ],
      "name": "Neil Haranhalli"
    },
    {
      "affiliations": [
        "Department of Neurology, University of Texas McGovern Medical School, Houston, Texas, USA"
      ],
      "name": "Michael Nahhas"
    },
    {
      "affiliations": [
        "Department of Neurointerventional Radiology, Lehigh Valley Health Network, Allentown, Pennsylvania, USA"
      ],
      "name": "Darryn Shaff"
    },
    {
      "affiliations": [
        "Department of Neurointerventional Radiology, Baylor University Medical Center at Dallas, Dallas, Texas, USA"
      ],
      "name": "Kennith F Layton"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Tallahassee Memorial Hospital, Florida State University, Tallahassee, Florida, USA"
      ],
      "name": "Narlin Beaty"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of Miami Health System, Miami, Florida, USA"
      ],
      "name": "Robert M Starke"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Erlanger Health System, Chattanooga, Tennessee, USA"
      ],
      "name": "Harris Hawk"
    },
    {
      "affiliations": [
        "Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA"
      ],
      "name": "Diogo C Haussen"
    },
    {
      "affiliations": [
        "Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA"
      ],
      "name": "Aqueel Pabaney"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Christopher Paul Kellner"
    },
    {
      "affiliations": [
        "Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA"
      ],
      "name": "Raul G Nogueira"
    }
  ],
  "title": "Stroke thrombectomy with a novel reperfusion system including a 0.088′′ aspiration catheter: the Imperative Trial",
  "uid": "429f8785-e6d7-5b74-912c-7ac2913d2cab"
}