{
  "abstract": "Introduction Intracranial aneurysms are routinely managed using minimally invasive endovascular techniques aimed at excluding the lesion from the cerebral circulation. The Kaneka Endovascular Embolization and Protection (KEEP) study was designed to evaluate the safety and effectiveness of the Kaneka i-ED Coil System in the treatment of both ruptured and unruptured intracranial aneurysms.Methods This post-market, prospective, multicenter, single-arm registry was designed to collect real-world clinical data to assess both acute and long-term performance of the i-ED Coil System. Eligible patients presented with bifurcation or sidewall aneurysms measuring 4–14 mm. A total of 163 patients were enrolled following Institutional Review Board (IRB)-approved and all patients signed an IRB approved informed consent. The primary endpoint, assessed by an independent core laboratory, was the proportion of patients achieving adequate aneurysm occlusion—defined as Modified Raymond-Roy Classification (MRRC) grades I or II at 12 months without retreatment. Secondary endpoints included coil packing density, longitudinal changes in aneurysm occlusion (MRRC), and functional outcomes measured by the modified Rankin Scale (mRS). Procedure and device-related serious adverse events were independently adjudicated.Results Between December 2022 and December 2024, 163 patients were enrolled across 17 academic and private clinical centers. The cohort included 117 females (71.7%) and 46 males (28.3%), with a mean age of 62.5 years (range: 27–80 years).Of the aneurysms treated, 120 (73.6%) were unruptured and 43 (26.4%) were ruptured. Aneurysm size ranged from 4 mm to 11 mm, with 78.5% measuring between 4 mm and 7 mm. The mean neck size was 3.4 mm (range: 1.9–9.0 mm). The coils were used as a stand-alone treatment in 85.2% of cases and in conjunction with adjunctive devices in 14.8% of cases.Among 126 patients with 12-month imaging follow-up, 110 (87.3%) achieved adequate occlusion (MRRC I or II), 15 (11.9%) were classified as MRRC III, and 1 case was indeterminate due to imaging artifact from coil mass.A total of 10 device or procedure-related serious adverse events occurred in 9 patients. There were no device or procedure-related deaths; however, two unrelated deaths were reported (one due to malignancy and one due to pulmonary disease).Retreatment was required in 12 patients (7.3%), with 6 occurring within 6 months and 6 between 7 and 12 months. In 8 of these cases, adjunctive stent placement was performed at the time of retreatment.Conclusion Endovascular coil embolization remains a well-established, minimally invasive treatment modality for intracranial aneurysms, promoting aneurysm occlusion through flow disruption and thrombus formation. The findings from this registry suggest that the i-ED Coil System demonstrates favorable occlusion rates and an acceptable safety profile in real-world clinical practice. Continued follow-up and expanded patient cohorts are warranted to further validate long-term outcomes and strengthen the evidence of this coil technology.Disclosures M. Hussain: 1; C; Kaneka - PI KEEP study. 2; C; Kaneka. W. Mack: 1; C; Kaneka - PI KEEP study. 6; C; Kaneka. A. Puri: 1; C; Kaneka - PI KEEP study. A. Ahmed: 2; C; Kaneka. R.V. Chitale: 2; C; Kaneka. I. Kaminsky: None. K. Khatibi: 2; C; Kaneka. R. Kaushal: None. J. Miller: 2; C; Kaneka. K. Shah: None. K. Shah: 2; C; Kaneka. K. Yaeger: 2; C; Kaneka. B. Yim: 2; C; Kaneka.",
  "authors": [
    {
      "affiliations": [
        "Cerebrovascular Center, Cleveland Clinic, Cleveland, OH"
      ],
      "name": "M Hussain"
    },
    {
      "affiliations": [
        "University of Southern California, Los Angeles, CA"
      ],
      "name": "W Mack"
    },
    {
      "affiliations": [
        "Department of Radiology, Division Neuroimaging and Intervention, University of Massachusetts Medical School, Worcester, MA"
      ],
      "name": "A Puri"
    },
    {
      "affiliations": [
        "Radiology, Boston Medical Center, Boston, MA"
      ],
      "name": "M Abdalkader"
    },
    {
      "affiliations": [
        "Neurological Surgery, University of Wisconsin, Madison, WI"
      ],
      "name": "A Ahmed"
    },
    {
      "affiliations": [
        "Rush, Chicago, IL"
      ],
      "name": "M Chen"
    },
    {
      "affiliations": [
        "Neurosurgery, Vanderbilt University Medical Center, Nashville, TN"
      ],
      "name": "RV Chitale"
    },
    {
      "affiliations": [
        "Swedish Hospital, Englewood, CO"
      ],
      "name": "S Hakeem"
    },
    {
      "affiliations": [
        "Swedish Hospital, Englewood, CO"
      ],
      "name": "I Kaminsky"
    },
    {
      "affiliations": [
        "Neurosurgery, UCLA, Los Angeles, CA"
      ],
      "name": "K Khatibi"
    },
    {
      "affiliations": [
        "Palmetto Hospital, Hialeah, FL"
      ],
      "name": "R Kaushal"
    },
    {
      "affiliations": [
        "Cleveland Clinic Florida, Port St Lucie, FL"
      ],
      "name": "J Miller"
    },
    {
      "affiliations": [
        "Neurology, Detroit Medical Center, Troy, MI"
      ],
      "name": "A Majjhoo"
    },
    {
      "affiliations": [
        "Aurora St Luke’s Hospital, Milwaukee, WI"
      ],
      "name": "K Shah"
    },
    {
      "affiliations": [
        "Aurora St Luke’s Hospital, Milwaukee, WI"
      ],
      "name": "K Shah"
    },
    {
      "affiliations": [
        "Houston Methodist, Houston, TX"
      ],
      "name": "K Yaeger"
    },
    {
      "affiliations": [
        "Neurosurgery, John Muir Hospital, Walnut Creek, CA"
      ],
      "name": "B Yim"
    }
  ],
  "title": "O-064 Post market registry for endovascular treatment of intracranial aneurysms using the i-ED coil system",
  "uid": "3defeef6-a8c2-536e-bf7c-c44d836129f3"
}