PROximal TEmporary oCclusion using balloon guide caTheter for Mechanical Thrombectomy (PROTECT-MT)

Background and Rationale: Uncertainty 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. Objective: To 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. Design: Proximal 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. Progress: Recruitment 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. Discussion: PROTECT-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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov Identifier: [NCT05592054][1] ### Funding Statement Funded by Shanghai Hospital Development Center (SHDC2022CR019), the Biopharma Industry Promotion Center Shangha(i FW2023CYBG01), and Ton-bridge Medical Technology Co., Ltd. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The medical ethical committee and research board of the Changhai Hospital, Shanghai, approved this study in China (CHEC2023-301). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05592054&atom=%2Fmedrxiv%2Fearly%2F2024%2F07%2F13%2F2024.07.12.24310194.atom