A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol

INTRODUCTION: Current evidence indicates endovascular intervention is a safe and effective treatment for peripheral artery disease of the lower extremity. However, the clinical outcome of endovascular intervention for femoropopliteal lesions has been shown to be affected by the status of tibial runoff. It remains unclear whether endovascular intervention for tibial runoff is associated with additional benefits. METHODS AND ANALYSIS: This prospective, multicenter, real-world observational study is carried out from January 2021 to December 2022 in 8 designated centers across China with an estimated sample size of 1200 patients with severe femoropopliteal disease. The pre-procedural status of tibial runoff is evaluated with the modified SVS score and categorized as good (SVS <5), compromised (SVS 5–10) or poor (SVS >10). Whether the patient will be treated with endovascular intervention for tibial runoff is determined by the treating vascular surgeons. Patients are dichotomized into the intervention group and the non-intervention group, with each group further divided into the good, compromised and poor tibial run-off subgroup, yielding 6 subgroups in total. Patients within various subgroups are compared with regard to the primary patency rate of the femoropopliteal artery, changes in quality of life, changes of Rutherford category, improvement of the Wound, Ischemia, and Foot Infection Classification, and incidence of major adverse events over 24-months follow-up. The results of this study may provide important information to help vascular sspecialists to decide whether the tibial runoff should be endovascularly intervened and which patient population benefits most from tibial runoff intervention. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04675632?id=NCT04675632&draw=2&rank=1, NCT04675632.