REVASCAT: a randomized trial of revascularization with SOLITAIRE FR® device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset

REVASCAT is a prospective, multicenter, randomized trial seeking to establish whether subjects meeting following main inclusion criteria: age 18-80, baseline National Institutes of Health Stroke Scale 6, evidence of intracranial internal carotid artery or proximal (M1 segment) middle cerebral artery occlusion, Alberta Stroke Program Early Computed Tomography score of >7 on non-contrast CT or >6 on diffusion-weighted magnetic resonance imaging , ineligible for or with persistent occlusion after intravenous alteplase and procedure start within 8 hours from symptom onset, have higher rates of favorable outcome when treated with the SolitaireTM FR embolectomy device compared to standard medical therapy alone The primary end-point, based on intention-to-treat criteria is the distribution of modified Rankin Scale scores at 90 days. Projected sample size is 690 patients. Estimated common odds ratio is 1.615. Randomization is performed under a minimization process using age, baseline NIHSS, therapeutic window, occlusion location and investigational center. The study follows a sequential analysis (triangular model) with the first approach to test efficacy at 174 patients and subsequent analyses (if necessary) at 346, 518, and 690 subjects. Secondary end-points are infarct volume evaluated on CT at 24h, dramatic early favorable response, defined as NIHSS of 0-2 or NIHSS improvement 8 points at 24h and successful recanalization in the Solitaire arm according to the thrombolysis in cerebral infarction (TICI) classification defined as TICI 2b or 3. Safety variables are mortality at 90 days, symptomatic intracranial haemorrhage rates at 24 hours and procedure related complications.