A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol
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...
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1035659/full |
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| author | Yang Liu Qiqi Wang Ziheng Wu Zibo Fen Lianrui Guo Qiang Li Xin Fang Hongfei Sang Yudi Dai Chunshui He Meng Ye |
| author_facet | Yang Liu Qiqi Wang Ziheng Wu Zibo Fen Lianrui Guo Qiang Li Xin Fang Hongfei Sang Yudi Dai Chunshui He Meng Ye |
| author_sort | Yang Liu |
| collection | DOAJ |
| description | 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.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04675632?id=NCT04675632&draw=2&rank=1, NCT04675632. |
| first_indexed | 2024-04-12T09:18:40Z |
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| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-12T09:18:40Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-ca0d2cc2681c4f7a974700127496492a2022-12-22T03:38:45ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-11-01910.3389/fcvm.2022.10356591035659A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocolYang Liu0Qiqi Wang1Ziheng Wu2Zibo Fen3Lianrui Guo4Qiang Li5Xin Fang6Hongfei Sang7Yudi Dai8Chunshui He9Meng Ye10Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital of Medicine College of Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical College of Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, ChinaDepartment of Vascular Surgery, Qingdao Haici Hospital Affiliated to Qingdao University, Qingdao, ChinaDepartment of Vascular Surgery, School of Medicine, Affiliated Hangzhou First People's Hospital, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, ChinaBiomedical Informatics and Statistics Center, Fudan University School of Public Health, Shanghai, ChinaDepartment of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaIntroductionCurrent 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.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04675632?id=NCT04675632&draw=2&rank=1, NCT04675632.https://www.frontiersin.org/articles/10.3389/fcvm.2022.1035659/fullarteriosclerosis obliteransendovascular interventionfemoropopliteal lesiontibial runoffprotocol |
| spellingShingle | Yang Liu Qiqi Wang Ziheng Wu Zibo Fen Lianrui Guo Qiang Li Xin Fang Hongfei Sang Yudi Dai Chunshui He Meng Ye A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol Frontiers in Cardiovascular Medicine arteriosclerosis obliterans endovascular intervention femoropopliteal lesion tibial runoff protocol |
| title | A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol |
| title_full | A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol |
| title_fullStr | A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol |
| title_full_unstemmed | A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol |
| title_short | A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol |
| title_sort | prospective multicenter real world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions research protocol |
| topic | arteriosclerosis obliterans endovascular intervention femoropopliteal lesion tibial runoff protocol |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1035659/full |
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