Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Trial: Protocol for a Randomized, Controlled, Multicenter Study Comparing the Solitaire Revascularization Device with IV tPA with IV tPA Alone in Acute Ischemic Stroke

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  • Jeffrey L. Saver
    Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles, Los Angeles, CA, USA
  • Mayank Goyal
    Department of Radiology, University of Calgary, Calgary, AB, Canada
  • Alain Bonafe
    Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier, France
  • Hans-Christoph Diener
    Department of Neurology, University Hospital of University Duisburg-Essen, Essen, Germany
  • Elad I. Levy
    Department of Neurosurgery, State University of New York at Buffalo, Buffalo, NY, USA
  • Vitor M. Pereira
    Division of Neuroradiology, Toronto Western Hospital, Toronto, ON, Canada
  • Gregory W. Albers
    Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, USA
  • Christophe Cognard
    Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, Toulouse, France
  • David J. Cohen
    Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA
  • Werner Hacke
    Department of Neurology, University of Heidelberg, Heidelberg, Germany
  • Olav Jansen
    Department of Radiology and Neuroradiology, Christian-Albrechts-University Kiel, Kiel, Germany
  • Tudor G. Jovin
    Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
  • Heinrich P. Mattle
    Department of Neurology, Inselspital, University of Bern, Bern, Switzerland
  • Raul G. Nogueira
    Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA
  • Adnan H. Siddiqui
    Department of Neurosurgery, Toshiba Stroke and Vascular Research Center, University at Buffalo State University of New York at Buffalo, Buffalo, NY, USA
  • Dileep R. Yavagal
    Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine/Jackson Memorial Hospital, Miami, FL, USA
  • Thomas G. Devlin
    Division of Neurology, Erlanger Hospital at University of Tennessee, Chattanooga, TN, USA
  • Demetrius K. Lopes
    Department of Neurosurgery, Rush University Medical Center, Chicago, IL, USA
  • Vivek Reddy
    Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
  • Richard du Mesnil de Rochemont
    Institute of Neuroradiology, Klinikum der Goethe-Universität, Frankfurt, Germany
  • Reza Jahan
    Division of Interventional Neuroradiology, University of California Los Angeles, Los Angeles, CA, USA

Description

<jats:sec><jats:title>Rationale</jats:title><jats:p> Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. </jats:p></jats:sec><jats:sec><jats:title>Aim</jats:title><jats:p> The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. </jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p> The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. </jats:p></jats:sec><jats:sec><jats:title>Procedures</jats:title><jats:p> Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. </jats:p></jats:sec><jats:sec><jats:title>Study Outcomes</jats:title><jats:p> The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. </jats:p></jats:sec><jats:sec><jats:title>Analysis</jats:title><jats:p> Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0–2). </jats:p></jats:sec>

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