{
  "abstract": "Background The River stent is the first stent specifically designed for intracranial venous sinuses. We report the 1-year results of the River trial, performed to obtain Humanitarian Device Exemption approval of the River stent in the United States (US).Methods The River trial was a prospective, open-label, multicenter, single-arm trial which enrolled 39 subjects at 5 US centers. Eligible patients had clinical diagnosis of idiopathic intracranial hypertension (IIH) with severe headaches or visual field loss and had failed medical therapy. The primary safety endpoint was the 1-year rate of major adverse events compared with cerebrospinal fluid (CSF) shunting using historical controls. The primary benefit endpoint was a composite at 1 year of clinical improvement and absence of venous sinus stenosis. Secondary endpoints included improvement in pulsatile tinnitus, visual symptoms, quality of life (QOL) scores, and medications.Results All procedures were technically successful. There was one serious adverse event, a gastrointestinal hemorrhage observed 2 months after the procedure while the patient was still on dual antiplatelet therapy. The primary safety endpoint was met with a rate of major adverse event of 5.4% versus 51.7% for CSF shunts. The primary benefit endpoint was achieved in 60% of trial participants. Additional improvements were also observed in opening CSF pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and QOL scores. Post hoc analysis demonstrated that subjects with minimal or absent papilledema at baseline showed similar improvement compared with subjects with papilledema at baseline, in terms of headaches, pulsatile tinnitus, and QOL.Conclusions The River study 1- year results establish safety and suggest efficacy for venous sinus stenting in IIH subjects who have failed medical therapy.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurological Surgery, North Shore University Hospital, Manhasset, New York, USA"
      ],
      "name": "Athos Patsalides"
    },
    {
      "affiliations": [
        "Neurological Surgery and Radiology, Wake Forest University, Winston-Salem, North Carolina, USA"
      ],
      "name": "Kyle M Fargen"
    },
    {
      "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 Neurological Surgery, Divison of Interventional Neuroradiology, NewYork-Presbyterian Hospital, Weill Cornell Medical Center, New York, New York, USA"
      ],
      "name": "Srikanth R Boddu"
    },
    {
      "affiliations": [
        "Departments of Neurology and Ophthalmology, NewYork-Presbyterian Hospital, Weill Cornell Medical College, New York, New York, USA"
      ],
      "name": "Marc Dinkin"
    },
    {
      "affiliations": [
        "Charles T. Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health & Science University, Portland, Oregon, USA"
      ],
      "name": "Ryan Priest"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Northwell Health, Great Neck, New York, USA"
      ],
      "name": "Howard D Pomeranz"
    },
    {
      "affiliations": [
        "Departments of Radiology and Neurosurgery, Weill Cornell Medicine, NewYork-Presbyterian Hospital, New York, New York, USA"
      ],
      "name": "Y Pierre Gobin"
    },
    {
      "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": "Adnan H Siddiqui"
    }
  ],
  "title": "The River study: the first prospective multicenter trial of a novel venous sinus stent for the treatment of idiopathic intracranial hypertension",
  "uid": "081207c2-1f82-5d39-bb8a-0ff3a02b1b83"
}