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
| Autor: | Saver, Jeffrey L, Goyal, Mayank, Bonafe, Alain, Diener, Hans-Christoph, Levy, Elad I, Pereira, Vitor M, Albers, Gregory W, Cognard, Christophe, Cohen, David J, Hacke, Werner, Jansen, Olav, Jovin, Tudor G, Mattle, Heinrich P, Nogueira, Raul G, Siddiqui, Adnan H, Yavagal, Dileep R, Devlin, Thomas G, Lopes, Demetrius K, Reddy, Vivek, du Mesnil de Rochemont, Richard, Jahan, Reza, SWIFT PRIME Investigators |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_treatment Medizin Severity of Illness Index recanalization Brain Ischemia Modified Rankin Scale Occlusion 80 and over Prospective Studies Thrombectomy Aged 80 and over Cerebral infarction SWIFT PRIME Investigators clinical trial Thrombolysis Middle Aged X-Ray Computed stent retriever Stroke Treatment Outcome Neurology Tissue Plasminogen Activator Injections Intravenous endovascular Stents Female Intravenous Perfusion Adult Solitaire Cryptographic Algorithm medicine.medical_specialty acute ischemic stroke thrombolysis Tomography Scanners X-Ray Computed Adolescent Clinical Trials and Supportive Activities Clinical Sciences Bioengineering 610 Medicine & health and over Revascularization Injections Young Adult Fibrinolytic Agents Clinical Research medicine Humans Aged Tomography Scanners Neurology & Neurosurgery business.industry Neurosciences medicine.disease Brain Disorders Surgery Clinical trial business Protocols Magnetic Resonance Angiography Follow-Up Studies |
| Zdroj: | International journal of stroke : official journal of the International Stroke Society, vol 10, iss 3 Saver, J L, Goyal, M, Bonafe, A, Diener, H-C, Levy, E I, Pereira, V M, Albers, G W, Cognard, C, Cohen, D J, Hacke, W, Jansen, O, Jovin, T G, Mattle, H P, Nogueira, R G, Siddiqui, A H, Yavagal, D R, Devlin, T G, Lopes, D K, Reddy, V, du Mesnil de Rochemont, R, Jahan, R, SWIFT PRIME Investigators & Andersen, G 2015, ' 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 ', International Journal of Stroke, vol. 10, no. 3, pp. 439-48 . https://doi.org/10.1111/ijs.12459 International Journal of Stroke Saver, Jeffrey L; Goyal, Mayank; Bonafe, Alain; Diener, Hans-Christoph; Levy, Elad I; Pereira, Vitor M; Albers, Gregory W; Cognard, Christophe; Cohen, David J; Hacke, Werner; Jansen, Olav; Jovin, Tudor G; Mattle, Heinrich P.; Nogueira, Raul G; Siddiqui, Adnan H; Yavagal, Dileep R; Devlin, Thomas G; Lopes, Demetrius K; Reddy, Vivek; du Mesnil de Rochemont, Richard; ... (2015). 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. International journal of stroke, 10(3), pp. 439-448. Blackwell Publishing 10.1111/ijs.12459 |
| Popis: | Rationale 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. 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 Solitaire 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 Solitaire device within six-hours of symptom onset. Study Outcomes 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. Analysis 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). |
| Databáze: | OpenAIRE |
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