Open Access

Jeffrey L. Saver, Mayank Goyal, Alain Bonafe, Hans-Christoph Diener, Elad I. Levy, Vitor M. Pereira, Gregory W. Albers, Christophe Cognard, David J. Cohen, Werner Hacke, Olav Jansen, Tudor G. Jovin, Tudor G. Jovin, Heinrich P. Mattle, Raul G. Nogueira, Adnan H. Siddiqui, Dileep R. Yavagal, Thomas G. Devlin, Demetrius K. Lopes, Vivek Reddy, Richard Klaus Frieder Du Mesnil de Rochemont, Reza Jahan

• Rationale: Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. S olitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. Aim: 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 S olitaire revascularization devices reduces degree of disability 3 months post stroke. Design: 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. Procedures: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 S olitaire device within six‐hours of symptom onset. Study Outcomes: The primary end‐point is 90‐day global disability, assessed with the modified R ankin S cale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in N ational I nstitutes of H ealth S troke S cale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. Analysis:Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified R ankin S cale (R ankin shift) and proportions of subjects achieving functional independence (mRS 0–2).