{
  "abstract": "Introduction Preclinical animal experiments and initial feasibility studies in humans have shown encouraging outcomes using the novel Saccular Endovascular Aneurysm Lattice (SEAL™) system for the treatment of both ruptured and unruptured wide-neck intracranial aneurysms (IAs). The SEAL™ Interventional Pivotal IDE PMA Trial (SEAL™ IT) is designed to assess the safety and efficacy of the SEAL™ in patients with saccular IAs. This ongoing, prospective, multicenter trial includes three study arms and will enroll a total of 279 participants with wide-neck bifurcation (WNBA), sidewall (SW), or acutely ruptured IAs across 50 U.S. sites.Methods Eligibility requirements include patients aged 20-80 years with a wide-neck saccular intracranial aneurysm (2-19 mm) deemed suitable for treatment with the SEAL™ Intrasaccular Device (SID). Participants receive treatment using the SEAL™ device (Galaxy Therapeutics Inc.) and are monitored at discharge, and again at 3, 6, and 12 months, followed by yearly assessments for up to 5 years. The primary efficacy outcome is defined as complete aneurysm occlusion at 12 months without evidence of parent vessel stenosis or the need for retreatment, as determined by an independent core laboratory. Key safety outcomes include neurological death within 12 months, stroke occurring within the first 30 days, and ipsilateral stroke between 30 days and 1 year.Results As of submission, 163 WNBA, 59 WNSW, and 58 ruptured for a total of 280 patients (76.0% female; mean age 61.6 ± 11.3) have been enrolled at 50 sites. Mean aneurysm width was 5.5 ± 2.3, neck size of 3.9 ± 1.5, and neck-to-dome ratio of 1.5 ± 0.33. SEAL Arc was used in 64.8% and SEAL Base in 35.2%. Technical device success rate is 99.4% for WNBA, 96.6% WNSW, and 98.2% ruptured. The interim complete occlusion rate for the primary group is 71.6% at most recent date based on available imaging.Disclosures D. Altschul: None. B. Jankowitz: None. X. Xin: None. S. Dandapat: None. E. Afreen: None. T. Kass-Hout: None. V. Bansal: None. H. Cuellar-Saenz: None. N. Swamy: None. V. Srinivasan: None. P. Khandelwal: None. P. Bhuva: None. N. Janjua: None. J. Eliyas: None. K. Ebersole: None. R. Priest: None. I. Abecassis: None. F. Almufti: None. E. Pereira: None. A. Badruddin: None. K. Woodward: None. T. Wolfe: None. M. Oliver: None.",
  "authors": [
    {
      "affiliations": [
        "Montefiore Einstein Medical Center, Bronx, NY"
      ],
      "name": "D Altschul"
    },
    {
      "affiliations": [
        "JFK University Medical Center, Edison, NJ"
      ],
      "name": "B Jankowitz"
    },
    {
      "affiliations": [
        "Neurological Surgery, Cooper University Hospital, Camden, NJ"
      ],
      "name": "S Boo"
    },
    {
      "affiliations": [
        "Neurological Surgery, Cooper University Hospital, Camden, NJ"
      ],
      "name": "D Tonetti"
    },
    {
      "affiliations": [
        "Cleveland, OH"
      ],
      "name": "M Hussain"
    },
    {
      "affiliations": [
        "Neurosurgery, RUSH University, Chicago, IL"
      ],
      "name": "D Lopes"
    },
    {
      "affiliations": [
        "Mercy Health St. Vincent Medical Center, Toledo, OH"
      ],
      "name": "X Xin"
    },
    {
      "affiliations": [
        "ponte vedra, FL"
      ],
      "name": "R Hanel"
    },
    {
      "affiliations": [
        "Advocate Health - St. Luke’s, Milwaukee, WI"
      ],
      "name": "S Dandapat"
    },
    {
      "affiliations": [
        "SUNY SB, Stony Brook, NY"
      ],
      "name": "D Fiorella"
    },
    {
      "affiliations": [
        "Promedica Toledo Hospital, Toledo, OH"
      ],
      "name": "E Afreen"
    },
    {
      "affiliations": [
        "Neurological Surgery, Cooper University Hospital, Camden, NJ"
      ],
      "name": "R Grandhi"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Endeavor Health, Evanston, IL"
      ],
      "name": "WJ Ares"
    },
    {
      "affiliations": [
        "University of Chicago, Chicago, IL"
      ],
      "name": "T Kass-Hout"
    },
    {
      "affiliations": [
        "Javon Bea Hospital-Riverside, Rockford, IL"
      ],
      "name": "V Bansal"
    },
    {
      "affiliations": [
        "LSU Health Shreveport, Shreveport, LA"
      ],
      "name": "H Cuellar-Saenz"
    },
    {
      "affiliations": [
        "Los Robles Hospital, Thousand Oaks, CA"
      ],
      "name": "N Swamy"
    },
    {
      "affiliations": [
        "University of Pennsylvania, Philadelphia, PA"
      ],
      "name": "V Srinivasan"
    },
    {
      "affiliations": [
        "Neurosurgery, Wellstar Medical Group, Marietta, GA"
      ],
      "name": "A Khaldi"
    },
    {
      "affiliations": [
        "Neurological Surgery, Cooper University Hospital, Camden, NJ"
      ],
      "name": "S Wolfe"
    },
    {
      "affiliations": [
        "New York, NY"
      ],
      "name": "S Majidi"
    },
    {
      "affiliations": [
        "NeuroInterventional Surgery, Baptist Cardiac & Vascular Institute, Miami, FL"
      ],
      "name": "G Dabus"
    },
    {
      "affiliations": [
        "Kingwood, TX"
      ],
      "name": "M Ezzeldin"
    },
    {
      "affiliations": [
        "Rutgers New Jersey Medical School, Newark, NJ"
      ],
      "name": "P Khandelwal"
    },
    {
      "affiliations": [
        "HCA Medical City, Plano, TX"
      ],
      "name": "P Bhuva"
    },
    {
      "affiliations": [
        "Semmes-Murphy, Memphis, TN"
      ],
      "name": "L Elijovich"
    },
    {
      "affiliations": [
        "University of Miami, Miami, FL"
      ],
      "name": "RM Starke"
    },
    {
      "affiliations": [
        "Neurosurgery, Carondelet Neurological Institute, Tucson, AZ"
      ],
      "name": "AL Coon"
    },
    {
      "affiliations": [
        "Pomona Valley Hospital, Pomona, CA"
      ],
      "name": "N Janjua"
    },
    {
      "affiliations": [
        "Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, MN"
      ],
      "name": "JE Delgado"
    },
    {
      "affiliations": [
        "University at Buffalo, Buffalo, NY"
      ],
      "name": "JM Davies"
    },
    {
      "affiliations": [
        "St. Francis Hospital, Hartford, CT"
      ],
      "name": "J Eliyas"
    },
    {
      "affiliations": [
        "University of Kansas, Kansas City, KS"
      ],
      "name": "K Ebersole"
    },
    {
      "affiliations": [
        "Neurosurgery, University of Virginia, Charlottesville, VA"
      ],
      "name": "RT Kellogg"
    },
    {
      "affiliations": [
        "Oregon Health & Science University, Portland, OR"
      ],
      "name": "R Priest"
    },
    {
      "affiliations": [
        "University of Louisville, Louisville, KY"
      ],
      "name": "I Abecassis"
    },
    {
      "affiliations": [
        "Westchester Medical Center, Valhalla, NY"
      ],
      "name": "F Almufti"
    },
    {
      "affiliations": [
        "Neuroendovascular Surgery, Americas Clinic, Medellin, Colombia"
      ],
      "name": "B Pabon"
    },
    {
      "affiliations": [
        "McLeod Health, Florence, SC"
      ],
      "name": "E Pereira"
    },
    {
      "affiliations": [
        "Powers Health, East Chicago, IN"
      ],
      "name": "A Badruddin"
    },
    {
      "affiliations": [
        "Vista Radiology, Knoxville, TN"
      ],
      "name": "K Woodward"
    },
    {
      "affiliations": [
        "Aurora Health Care, Milwaukee, WI"
      ],
      "name": "T Wolfe"
    },
    {
      "affiliations": [
        "Thomas Jefferson University Hospital, Philadelphia, PA"
      ],
      "name": "P Jabbour"
    },
    {
      "affiliations": [
        "Radiology, University Radiology Group, East Brunswick, NJ"
      ],
      "name": "S Roychowdhury"
    },
    {
      "affiliations": [
        "Advocate Health - Lutheran General, Park Ridge, IL"
      ],
      "name": "M Oliver"
    },
    {
      "affiliations": [
        "Galaxy Therapeutics, Inc, Milpitas, CA"
      ],
      "name": "OO Zaidat"
    }
  ],
  "title": "O-070 Update on the saccular endovascular aneurysm lattice system interventional pivotal trial (SEAL™ IT)",
  "uid": "09706c4b-37b7-5edb-a7e0-67ad4c75c4c8"
}