{
  "abstract": "Introduction 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.Methods and analysis 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.Ethics and dissemination The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.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.Trial registration number ISRCTN14591444.",
  "authors": [
    {
      "affiliations": [
        "Cardiovascular Sciences, University of Leicester Medical School, Leicester, UK",
        "University of Leicester, Leicester, UK"
      ],
      "name": "Athanasios Saratzis"
    },
    {
      "affiliations": [
        "Vascular, Imperial College London, London, UK"
      ],
      "name": "Alun Davies"
    },
    {
      "affiliations": [
        "Interventional Radiology, Guy's and St Thomas’ Hospitals NHS Trust, London, UK"
      ],
      "name": "Athanasios Diamantopoulos"
    },
    {
      "affiliations": [
        "Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK"
      ],
      "name": "Robert S M Davies"
    },
    {
      "affiliations": [
        "Faculty of Economic and Business Sciences, University of Granada, Granada, Spain"
      ],
      "name": "David Epstein"
    },
    {
      "affiliations": [
        "University of Bristol School of Social and Community Medicine, Bristol, UK"
      ],
      "name": "Marcus Jepson"
    },
    {
      "affiliations": [
        "Faculty of Economic and Business Sciences, University of Granada, Granada, Spain"
      ],
      "name": "Daniel Perez"
    },
    {
      "affiliations": [
        "Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK"
      ],
      "name": "Despina Apergi"
    },
    {
      "affiliations": [
        "Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK"
      ],
      "name": "Keith Jonathan Harris"
    },
    {
      "affiliations": [
        "Vascular Surgery, Guy's and St Thomas’ NHS Foundation Trust Cardiovascular Centre, London, UK"
      ],
      "name": "Hany Zayed"
    },
    {
      "affiliations": [
        "Leicester Clinical Trials Unit, University of Leicester, Leicester, UK"
      ],
      "name": "Cassandra Brookes"
    },
    {
      "affiliations": [
        "Leicester Clinical Trials Unit, University of Leicester, Leicester, UK"
      ],
      "name": "Shaun Barber"
    },
    {
      "affiliations": [
        "Leicester Clinical Trials Unit, University of Leicester, Leicester, UK"
      ],
      "name": "Ana Suazo Di Paola"
    },
    {
      "affiliations": [
        "Leicester Clinical Trials Unit, University of Leicester, Leicester, UK"
      ],
      "name": "Luke Ingram"
    },
    {
      "affiliations": [
        "Leicester Clinical Trials Unit, University of Leicester, Leicester, UK"
      ],
      "name": "Carla Richardson"
    },
    {
      "affiliations": [
        "Leicester Clinical Trials Unit, University of Leicester, Leicester, UK"
      ],
      "name": "Anish Patel"
    }
  ],
  "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",
  "uid": "486e60e7-7093-5582-8508-2d93a0cf06bc"
}