Open AccessS olitaire ™ with the I ntention for T hrombectomy as P rimary E ndovascular T reatment for A cute I schemic S troke ( SWIFT PRIME ) trial: protocol for a randomized, controlled, multicenter study comparing the S olitaire revascularization device with IV t PA with IV t PA alone in acute ischemic stroke
Author(s) -
Saver Jeffrey L.,
Goyal Mayank,
Bonafe Alain,
Diener HansChristoph,
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
Publication year - 2015
Publication title -
international journal of stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.375
H-Index - 74
eISSN - 1747-4949
pISSN - 1747-4930
DOI - 10.1111/ijs.12459
Subject(s) - solitaire cryptographic algorithm , medicine , modified rankin scale , thrombolysis , clinical endpoint , randomized controlled trial , tissue plasminogen activator , stroke (engine) , revascularization , surgery , occlusion , ischemia , myocardial infarction , ischemic stroke , mechanical engineering , engineering
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 S olitaire 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).