The PROTECT-MT study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation (PROBE) trial, and aims to determine the effectiveness of balloon guide catheter(BGC) as compared to standard guide catheter on functional outcome (modified Rankin Scale [mRS] score at Day 90 of 0-2) in patients with acute ischemic stroke due to anterior circulation large vessel occlusion.~Primary Endpoints~Functional outcome, defined as modified Rankin Scale (mRS) score of 0-2, at 90 days (±14 days) .~Secondary Endpoints~Dichotomized mRS at 90 days after the operation (0-1 versus 2-6, 0-3 versus 4-6, 0-4 versus 5-6, 0-5 versus 6).~Change in stroke severity (NIHSS score) at 24 hours post treatment.~Change in stroke severity (NIHSS score) at 7 days post treatment or discharge (whichever occurs first).~Technical success rate (defined as successfully navigating the guide catheter into the target vessel, and finishing the mechanical thrombectomy procedure without changing to another guide catheter).~Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) in final angiogram.~Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) after the first pass.~Time from groin puncture to successful reperfusion (eTICI 2b or greater, eTICI 2c or greater).~Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access.~Number of thrombectomy attempts (final).~Occurrence of emboli to a new territory.~Safety Endpoints:~Deaths at 90 days (±14 days) post treatment.~Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first).~Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee.~Any Procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.
A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS.