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

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机构: [1]Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China, [2]Department of Vascular Surgery, The First Affiliated Hospital of Medicine College of Zhejiang University, Hangzhou, China, [3]Department of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China, [4]Department of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, China, [5]Department of Vascular Surgery, Qingdao Haici Hospital Affiliated to Qingdao University, Qingdao, China, [6]Department of Vascular Surgery, School of Medicine, Affiliated Hangzhou First People’s Hospital, Zhejiang University, Hangzhou, China, [7]Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China, [8]Biomedical Informatics and Statistics Center, Fudan University School of Public Health, Shanghai, China, [9]Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
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关键词: arteriosclerosis obliterans endovascular intervention femoropopliteal lesion tibial runoff protocol

摘要:
IntroductionCurrent 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 analysisThis 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.

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
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出版当年[2020]版:
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

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第一作者机构: [1]Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China,
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