Endovascular treatment plus placebo versus endovascular treatment plus intravenous thrombolysis in acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery: a multicenter randomized clinical trial: the M-TWO Trial

Abstract

BACKGROUND For patients with large vessel occlusion (LVO) strokes, it is unknown whether endovascular treatment (EVT) treatment alone compared with intravenous thrombolysis plus EVT (standard treatment) can achieve similar functional and safety outcomes.

OBJECTIVES To investigate whether EVT plus placebo is non-inferior to intravenous thrombolysis followed by EVT for achieving functional independence at 90 days (modified Rankin Scale 0-2) among patients with acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery (MCA). Secondary objectives to assess efficacy include investigating recanalization rates and final infarct volume at 72h measured by diffusion-weighted imaging (DWI). Secondary objectives to assess safety include symptomatic intracerebral haemorrhage (sICH), any intracerebral haemorrhage (ICH), any other haemorrhages and mortality rates.

METHODS Randomized, multicentric, prospective, double-blind, non-inferiority, controlled clinical trial. Intervention will be performed internationally in 50 stroke centres from Europe, USA and Canada