A Randomized Study to Compare the Efficacy of Primary Thrombectomy With Double Stent (DS-EVT) Versus Primary Thrombectomy With One Stent (SS-EVT) as an Initial Attempt at Thrombectomy

Prospective, multicenter, randomized, controlled, open and blinded trial of patients with acute stroke with acute large vessel occlusion (LGO) identified by ASD, in which two strategies will be compared: primary double stent (DS-EVT) versus simple stent (SS-EVT) as an initial attempt at thrombectomy.

Assignment will be stratified according to the initial location of the occlusion: terminal ICA, distal M1, and basilar artery.

The primary objective will be to evaluate the efficacy of the primary strategy DS-EVT defined as first-pass angiographic complete recanalization (TICI 2c-3) compared to SS-EVT.

The primary safety endpoint will assess the safety of the primary DS-EVT strategy compared to SS-EVT, defined as the occurrence of symptomatic intracerebral hemorrhage (sICH), along with any other serious procedure-related adverse events. (excluding those already accounted for in sICH) within 24 hours (-8/+12) after the procedure.

A designated Data Safety Monitoring Board (DSMB) will review the primary safety endpoint after every 25 new patients enrolled in the study and determine continuation of the study based on the occurrence of adverse events in each study arm to assess early completion of the study. A first interim efficacy analysis will be performed after enrolling 106 patients and enrollment will be stopped if a significant difference in first-pass recanalization between both groups is demonstrated according to pre-specified stopping rules.