Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis
Introduction Femoropopliteal artery in-stent restenosis (FP-ISR) represents one of the main obstacles for stent implantation in peripheral artery disease patients, especially Tosaka III FP-ISR, which is also referred to as in-stent occlusion. Diverse endovascular treatments of Tosaka III FP-ISR are...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e060200.full |
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| author | Qiang Li Xu Li Xin Fang Meng Ye Min Zhou Zhenyu Shi Hongfei Sang Yong Ding Ziheng Wu Zibo Feng Lianrui Guo |
| author_facet | Qiang Li Xu Li Xin Fang Meng Ye Min Zhou Zhenyu Shi Hongfei Sang Yong Ding Ziheng Wu Zibo Feng Lianrui Guo |
| author_sort | Qiang Li |
| collection | DOAJ |
| description | Introduction Femoropopliteal artery in-stent restenosis (FP-ISR) represents one of the main obstacles for stent implantation in peripheral artery disease patients, especially Tosaka III FP-ISR, which is also referred to as in-stent occlusion. Diverse endovascular treatments of Tosaka III FP-ISR are available, and the results are unequivocal. However, real-world data are limited. This study aims to evaluate the efficacy, safety and health economics evaluation of various endovascular procedures in the treatment of Tosaka III FP-ISR.Method and analysis This study is a prospective, multicentre, real-world, observational clinical study. Patients diagnosed with Tosaka III FP-ISR and treated with endovascular procedures in nine centres from 1 April 2021 to 31 December 2022 will be recruited. The relevant clinical information, Ankle-Brachial Index and CT angiography will be collected. All the participants will undergo follow-up at 1, 6, 12, 18 and 24 months after the operation. The primary outcome is freedom from clinically driven target lesion revascularisation at 24 months. Safety and health economics issues will also be reported.Ethics and dissemination The FP-RESTORE clinical trial has been registered at ClinicalTrials.gov (http://clinicaltrials.gov/). This study was also approved by the Institutional Review Board and Human Research Ethics Committee of Zhongshan Hospital, Fudan University (approval number: B2021-427). Moreover, written informed consent will be obtained at the time of recruitment. The study outcomes will be disseminated by publication in a peer-reviewed journal to provide information for further clinical practice.Trial registration number NCT04801004. |
| format | Article |
| id | doaj-art-0cdd1432ec314d8cae3379ddd948fe75 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-0cdd1432ec314d8cae3379ddd948fe752025-08-20T02:57:08ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2021-060200Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosisQiang Li0Xu Li1Xin Fang2Meng Ye3Min Zhou4Zhenyu Shi5Hongfei Sang6Yong Ding7Ziheng Wu8Zibo Feng9Lianrui Guo10Department of Vascular Surgery, Qingdao Haici Hospital, Qingdao, Shandong, China1 Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Vascular Surgery, Affiliated Hangzhou First People`s Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, ChinaDepartment of Vascular Surgery, Shanghai Jiaotong University, Shanghai, Minhang, ChinaDepartment of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, People`s Republic of China2 China Center for Health Development Studies, Peking University, Beijing, ChinaDepartment of Neurology, Hangzhou First People`s Hospital Affiliated of Westlake University School of Medicine, Hangzhou, Zhejiang, ChinaDepartment of Vascular Surgery, Institute of Vascular Surgery, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital Fudan University, Shanghai, Xuhui, ChinaDepartment of Vascular Surgery, Zhejiang University School of Medicine First Affiliated Hospital, Hangzhou, Zhejiang, ChinaDepartment of Vascular Surgery, Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, ChinaDepartment of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, Hebei, ChinaIntroduction Femoropopliteal artery in-stent restenosis (FP-ISR) represents one of the main obstacles for stent implantation in peripheral artery disease patients, especially Tosaka III FP-ISR, which is also referred to as in-stent occlusion. Diverse endovascular treatments of Tosaka III FP-ISR are available, and the results are unequivocal. However, real-world data are limited. This study aims to evaluate the efficacy, safety and health economics evaluation of various endovascular procedures in the treatment of Tosaka III FP-ISR.Method and analysis This study is a prospective, multicentre, real-world, observational clinical study. Patients diagnosed with Tosaka III FP-ISR and treated with endovascular procedures in nine centres from 1 April 2021 to 31 December 2022 will be recruited. The relevant clinical information, Ankle-Brachial Index and CT angiography will be collected. All the participants will undergo follow-up at 1, 6, 12, 18 and 24 months after the operation. The primary outcome is freedom from clinically driven target lesion revascularisation at 24 months. Safety and health economics issues will also be reported.Ethics and dissemination The FP-RESTORE clinical trial has been registered at ClinicalTrials.gov (http://clinicaltrials.gov/). This study was also approved by the Institutional Review Board and Human Research Ethics Committee of Zhongshan Hospital, Fudan University (approval number: B2021-427). Moreover, written informed consent will be obtained at the time of recruitment. The study outcomes will be disseminated by publication in a peer-reviewed journal to provide information for further clinical practice.Trial registration number NCT04801004.https://bmjopen.bmj.com/content/12/12/e060200.full |
| spellingShingle | Qiang Li Xu Li Xin Fang Meng Ye Min Zhou Zhenyu Shi Hongfei Sang Yong Ding Ziheng Wu Zibo Feng Lianrui Guo Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis BMJ Open |
| title | Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis |
| title_full | Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis |
| title_fullStr | Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis |
| title_full_unstemmed | Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis |
| title_short | Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis |
| title_sort | design of the fp restore study a protocol for prospective observational study of real world treatments with endovascular therapy in patients with femoropopliteal artery tosaka iii in stent restenosis |
| url | https://bmjopen.bmj.com/content/12/12/e060200.full |
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