TESLA Trial: Rationale, Protocol, and Design

Background Mechanical thrombectomy has been shown to be effective in patients with acute ischemic stroke secondary large‐vessel occlusion and small moderate infarct volume. However, there are no randomized clinical trials for large‐core volume comparing mechanical medical therapy the population selected based solely on noncontrast computed tomography brain scan. The TESLA (Thrombectomy Emergent Salvage of Large Anterior Circulation Ischemic Stroke) trial is designed address this question. Methods aim demonstrate efficacy (3‐month 1‐year disability following stroke) safety intraarterial large‐volume infarction assessed a design prospective, controlled, multicenter, open‐label, assessor‐blinded anterior circulation adaptive enrichment design, enrolling up 300 patients. Patients who meet imaging eligibility criteria basis Alberta Stroke Program Early CT Score (2–5) adjudicated by site investigator will 1:1 ratio undergo or best management 24 hours from last known well. Results primary outcome utility‐weighted modified Rankin Scale (mRS) score distribution at 90 days between groups. results an intention‐to‐treat analysis that examine Bayesian posterior probability that, adjusted Score, treated intra‐arterial have higher expected mRS than those alone. 90‐day death rate. Key outcomes dichotomized 0 2 3 outcomes, ordinal scores, quality life (EuroQol 5 Dimension Level survey) 1 year, hemicraniectomy rate, rate 24‐hour symptomatic intracranial hemorrhage both Conclusion pragmatic trial, unanswered question large infarcts diagnosed only scan symptoms onset.