{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T03:47:32Z","timestamp":1792036052894,"version":"4.4.0"},"reference-count":5,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:00:00Z","timestamp":1759795200000},"content-version":"unspecified","delay-in-days":6,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["NIHR151230"],"award-info":[{"award-number":["NIHR151230"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,9,18]]},"published-print":{"date-parts":[[2025,10]]},"abstract":"\n Introduction<\/jats:title>\n Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n \n The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23\/SW\/0065; trial registration reference:\n ISRCTN14591444<\/jats:ext-link>\n ). Informed consent will be obtained from all participants.\n <\/jats:p>\n The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n ISRCTN14591444<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-106474","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T05:26:37Z","timestamp":1759901197000},"page":"e106474","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Assessing the clinical and cost-effectiveness of endovascular vs open revascularisation in severe occlusive aorto-iliac disease (EVOCC trial): study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"isrctn14591444","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn14591444","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3399-094X","authenticated-orcid":false,"given":"Athanasios","family":"Saratzis","sequence":"first","affiliation":[{"name":"Cardiovascular Sciences, University of Leicester Medical School, Leicester, UK"},{"name":"University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5261-6913","authenticated-orcid":false,"given":"Alun","family":"Davies","sequence":"additional","affiliation":[{"name":"Vascular, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athanasios","family":"Diamantopoulos","sequence":"additional","affiliation":[{"name":"Interventional Radiology, Guy's and St Thomas\u2019 Hospitals NHS Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S M","family":"Davies","sequence":"additional","affiliation":[{"name":"Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Epstein","sequence":"additional","affiliation":[{"name":"Faculty of Economic and Business Sciences, University of Granada, Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Jepson","sequence":"additional","affiliation":[{"name":"University of Bristol School of Social and Community Medicine, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Perez","sequence":"additional","affiliation":[{"name":"Faculty of Economic and Business Sciences, University of Granada, Granada, 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