{
  "abstract": "Background Wide-necked intracranial aneurysms present unique challenges for endovascular treatment. The Comaneci device is a novel temporary bridging device designed to assist coil embolization without parent vessel occlusion.Methods The SUccess in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS) was a multicenter, prospective, postmarket surveillance study conducted at 17 US centers. Ninety consecutive patients with wide-necked intracranial aneurysms were treated with Comaneci-assisted coiling. The primary effectiveness endpoint was successful aneurysm occlusion (Raymond-Roy class I/II) at procedure end. Primary safety endpoints included periprocedural events within 24 hours and clinical outcomes at discharge and 30 days.Results Of 90 enrolled patients (mean age 63 years, 63% female), 32 (36%) presented with ruptured aneurysms. Most common locations were anterior communicating (33%), internal carotid (20%), and posterior communicating arteries (19%). Successful occlusion was achieved in 85.6% of cases at procedure end and 94.7% at 6 months. Good clinical outcome (modified Rankin Scale (mRS) 0–2) was maintained from baseline (73%) through 30 days (81%) and 6 months (83%). Thromboembolic events occurred in 5.5% of cases, all asymptomatic. Device-related complications were minimal, with coil entanglement in 0.3% of deployed coils and no instances of deployment/retrieval failure. All-cause mortality was 4.4%, confined to the ruptured aneurysm cohort.Conclusions The SUCCESS study demonstrates high rates of successful aneurysm occlusion with Comaneci-assisted coiling, with occlusion rates persisting through 6 month follow-up. The safety profile was favorable, with low rates of thromboembolic events compared with other assist techniques. These results support the use of the Comaneci device for wide-necked aneurysm treatment in both ruptured and unruptured settings.Trial registration number NCT04518670.",
  "authors": [
    {
      "affiliations": [
        "Neurosurgery and Bioinformatics and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA",
        "Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA"
      ],
      "name": "Jason M Davies"
    },
    {
      "affiliations": [
        "Department of Neurosurgery and Neurointervention, Los Robles Hospital and Medical Center, Thousand Oaks, Ca, Palm Springs, California, USA"
      ],
      "name": "Muhammad Asif Taqi"
    },
    {
      "affiliations": [
        "Carondelet Neurological Institute, St. Joseph’s Hospital, Tucson, AZ, Tucson, Arizona, USA"
      ],
      "name": "Alexander L Coon"
    },
    {
      "affiliations": [
        "Carondelet Neurological Institute, Carondelet Health Network, Tucson, Arizona, USA"
      ],
      "name": "Li-Mei Lin"
    },
    {
      "affiliations": [
        "Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA"
      ],
      "name": "Bradley Bohnstedt"
    },
    {
      "affiliations": [
        "Neurosurgery, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA"
      ],
      "name": "Justin Mascitelli"
    },
    {
      "affiliations": [
        "Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA",
        "Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA"
      ],
      "name": "Elad I Levy"
    },
    {
      "affiliations": [
        "University at Buffalo Neurosurgery Inc, Buffalo, New York, USA"
      ],
      "name": "Adnan Siddiqui"
    },
    {
      "affiliations": [
        "Neurosurgery, UT Health San Antonio, San Antonio, Texas, USA"
      ],
      "name": "Lee Birnbaum"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of Texas Health Science at San Antonio, San Antonio, Texas, USA"
      ],
      "name": "Pavel Rodriguez"
    },
    {
      "affiliations": [
        "Neurosurgery, Kaiser Permanente Southern California, Fontana, California, USA"
      ],
      "name": "Mazen Noufal"
    },
    {
      "affiliations": [
        "Neurosurgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA"
      ],
      "name": "Philipp Taussky"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, University of Utah, Salt Lake City, Utah, USA"
      ],
      "name": "Craig Kilburg"
    },
    {
      "affiliations": [
        "Thomas Jefferson University, Philadelphia, Pennsylvania, USA"
      ],
      "name": "M Reid Gooch"
    },
    {
      "affiliations": [
        "Radiology, University of Massachusetts, Worcester, Massachusetts, USA"
      ],
      "name": "Ajit S Puri"
    },
    {
      "affiliations": [
        "Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA"
      ],
      "name": "Orlando Diaz"
    },
    {
      "affiliations": [
        "Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Johanna T Fifi"
    },
    {
      "affiliations": [
        "Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Shahram Majidi"
    },
    {
      "affiliations": [
        "Texas Stroke Institute, Plano, Texas, USA"
      ],
      "name": "Albert J Yoo"
    },
    {
      "affiliations": [
        "Neurointervention, Texas Stroke Institute, Plano, Texas, USA"
      ],
      "name": "Jazba Soomro"
    },
    {
      "affiliations": [
        "Neuroendovascular Surgery, Texas Stroke Institute, Plano, Texas, USA"
      ],
      "name": "Parita Bhuva"
    },
    {
      "affiliations": [
        "Santa Barbara Cottage Hospital, Santa Barbara, California, USA"
      ],
      "name": "Robert A Taylor"
    },
    {
      "affiliations": [
        "University of Texas Health Science Center at Houston, Houston, Texas, USA"
      ],
      "name": "Akinwunmi O Oni-Orisan"
    },
    {
      "affiliations": [
        "Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA"
      ],
      "name": "Michael Chen"
    },
    {
      "affiliations": [
        "Lyerly Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA"
      ],
      "name": "Eric Sauvageau"
    },
    {
      "affiliations": [
        "Neurology, University of South Alabama, Mobile, Alabama, USA"
      ],
      "name": "Steve M Cordina"
    },
    {
      "affiliations": [
        "Department of Neurology, University of South Alabama College of Medicine, Mobile, Alabama, USA"
      ],
      "name": "Rebecca M Sugg"
    },
    {
      "affiliations": [
        "Radiology, University of Massachusetts, Worcester, Massachusetts, USA"
      ],
      "name": "Jasmeet Singh"
    },
    {
      "affiliations": [
        "Geisinger, Danville, Pennsylvania, USA"
      ],
      "name": "Oded Goren"
    },
    {
      "affiliations": [
        "Department of Neurology, University of California Los Angeles, Los Angeles, California, USA"
      ],
      "name": "David S Liebeskind"
    },
    {
      "affiliations": [
        "Lyerly Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA"
      ],
      "name": "Ricardo A Hanel"
    }
  ],
  "title": "Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study",
  "uid": "ebae60f6-ce4b-5abf-aa9e-04fa81089566"
}