Proxiaml Temporary Occlusion using Balloon Guide Catheter for Mechanical Thrombectomy (PROTECT-MT): Study protocol for a multicenter randomized trial

Abstract

AbstractBackground and RationaleUncertainty exists over balloon guide catheter(BGC) usage for Mechanical Thrombectomy(MT) in patients with acute ischemic stroke acute ischemic stroke due to anterior circulation large vessel occlusion.ObjectiveTo determine the effectiveness of balloon guide catheter(BGC) as compared to conventional guide catheter on functional outcome in patients with acute ischemic stroke and treated with MT.DesignProximal TEmporary oCclusion using balloon guide caTheter for Mechanical Thrombectomy (PROTECT-MT) is an investigator-initiated, multicenter, prospective, open label trial with blinded outcome assessment (PROBE design) assessing the effectiveness and safety of BGC in acute ischemic stroke. An estimated 1074 patients meet the inclusion criteria would be randomized (1:1) to receive either MT with BGC(intervention) or MT with conventional guide catheter(control). The primary outcome is an ordinal shift analysis of scores on the modified Rankin scale (mRS) at 90 days.ProgressRecruitment started on February 7, 2023. At a meeting of the independent Data and Safety Monitoring Board in November 2023 to review primary outcome data available for 169 patients, they recommended suspension of recruitment due to safety concerns, which was implemented by the Trial Steering Committee (TSC) with 329 randomized patients. The TSC stopped recruitment due to the safety concerns persisted on further review of the data on April 18, 2024.DiscussionPROTECT-MT is the largest RCT assessing the effectiveness of BGC versus conventional guide catheter on functional outcome in large vessel occlusion patients treated with MT, it will provide further randomized evidence on the role of BGC in AIS patients treated with MT.