{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T12:54:57Z","timestamp":1769000097363,"version":"3.49.0"},"reference-count":40,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2022,5,2]],"date-time":"2022-05-02T00:00:00Z","timestamp":1651449600000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"International Cardio Corporation"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,4,6]]},"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Peripheral arterial disease (PAD) is an atherosclerotic disease leading to stenosis and\/or occlusion of the arterial circulation of the lower extremities. The currently available revascularisation methods have an acceptable initial success rate, but the long-term patency is limited, while surgical revascularisation is associated with a relatively high perioperative risk. This urges the need for development of less invasive and more effective treatment modalities. This protocol article describes a study investigating a new non-invasive technique that uses robot assisted high-intensity focused ultrasound (HIFU) to treat atherosclerosis in the femoral artery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A pilot study is currently performed in 15 symptomatic patients with PAD with a significant stenosis in the common femoral and\/or proximal superficial femoral artery. All patients will be treated with the dual-mode ultrasound array system to deliver imaging-guided HIFU to the atherosclerotic plaque. Safety and feasibility are the primary objectives assessed by the technical feasibility of this therapy and the 30-day major complication rate as primary endpoints. Secondary endpoints are angiographic and clinical success and quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval for this study was obtained in 2019 from the Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands. Data will be presented at national and international conferences and published in a peer-reviewed journal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NL7564.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-058418","type":"journal-article","created":{"date-parts":[[2022,5,2]],"date-time":"2022-05-02T12:08:41Z","timestamp":1651493321000},"page":"e058418","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Safety and feasibility study of non-invasive robot-assisted high-intensity focused ultrasound therapy for the treatment of atherosclerotic plaques in the femoral artery: protocol for a pilot study"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0383-9699","authenticated-orcid":false,"given":"Michelle V","family":"Simons","sequence":"first","affiliation":[{"name":"Department of Vascular Medicine, University Medical Centre, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9900-6044","authenticated-orcid":false,"given":"Marijn H A","family":"Groen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Medical Centre, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1389-4141","authenticated-orcid":false,"given":"Gert J","family":"de Borst","sequence":"additional","affiliation":[{"name":"Vascular Surgery, University Medical Centre Speciality Surgery, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1885-5499","authenticated-orcid":false,"given":"Tim","family":"Leiner","sequence":"additional","affiliation":[{"name":"Radiology, University Medical Center Imaging Division, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6257-7169","authenticated-orcid":false,"given":"Pieter A F","family":"Doevendans","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Medical Centre, Utrecht, The Netherlands"},{"name":"Netherlands Heart Institue, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1334-5502","authenticated-orcid":false,"given":"Emad","family":"Ebbini","sequence":"additional","affiliation":[{"name":"Electrical and Computer Engineering, University of Minnesota College of Science and Engineering, Minneapolis, Minnesota, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0495-3170","authenticated-orcid":false,"given":"Fons J B","family":"Slieker","sequence":"additional","affiliation":[{"name":"Department of Oral Surgery, University Medical Centre, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9950-4388","authenticated-orcid":false,"given":"Ren\u00e9","family":"van Es","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Medical Centre, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2408-2720","authenticated-orcid":false,"given":"Constantijn E V B","family":"Hazenberg","sequence":"additional","affiliation":[{"name":"Vascular Surgery, University Medical Centre Speciality Surgery, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,5,2]]},"reference":[{"key":"2025121509454437000_12.5.e058418.1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.116.303503"},{"key":"2025121509454437000_12.5.e058418.2","doi-asserted-by":"crossref","unstructured":"Bartelink MEL , Elsman BHP , Oostindjer A . 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