{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T23:19:43Z","timestamp":1777072783428,"version":"3.51.4"},"reference-count":25,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2022,12,6]],"date-time":"2022-12-06T00:00:00Z","timestamp":1670284800000},"content-version":"unspecified","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81870342"],"award-info":[{"award-number":["81870342"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,11,12]]},"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      The FP-RESTORE clinical trial has been registered at ClinicalTrials.gov (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\/\">http:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n                      ). 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04801004\">NCT04801004<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-060200","type":"journal-article","created":{"date-parts":[[2022,12,6]],"date-time":"2022-12-06T09:35:28Z","timestamp":1670319328000},"page":"e060200","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"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"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04801004","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04801004","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Xu","family":"Li","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery, Institute of Vascular Surgery, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital Fudan University, Shanghai, Xuhui, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Institute of Vascular Surgery, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital Fudan University, Shanghai, Xuhui, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yong","family":"Ding","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Institute of Vascular Surgery, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital Fudan University, Shanghai, Xuhui, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8960-9733","authenticated-orcid":false,"given":"Ziheng","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Zhejiang University School of Medicine First Affiliated Hospital, Hangzhou, Zhejiang, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zibo","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lianrui","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, Hebei, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiang","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Qingdao Haici Hospital, Qingdao, Shandong, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Fang","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongfei","family":"Sang","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 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