{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T21:58:15Z","timestamp":1778623095409,"version":"3.51.4"},"reference-count":21,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Open Heart"],"accepted":{"date-parts":[[2018,3,6]]},"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Saphenous vein grafts (SVGs) remain the most often used conduits in coronary artery bypass grafting (CABG). However, they are prone to vein graft disease (VGD) during follow-up, which may compromise clinical outcomes. Injury to the SVG endothelium during harvesting and storage promotes neointimal hyperplasia that can advance to atherosclerosis characterised by SVG failure. This trial investigates the potential benefit of DuraGraft, a novel, one-time intraoperative graft treatment developed to efficiently protect the structural and functional integrity of the vascular endothelium, on the development and progression of VGD in CABG patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This ongoing prospective randomised, double-blinded multicentre trial (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02272582\">NCT02272582<\/jats:ext-link>\/NCT02774824) includes patients undergoing isolated CABG requiring at least two SVGs. It compares the impact of DuraGraft, a novel treatment against VGD versus the <jats:italic>standard-of-care<\/jats:italic> (SOC; heparinised saline) using a within-patient randomisation (with one SVG treated with DuraGraft and the other treated with SOC). Besides clinical assessments, patients undergo longitudinal 64-slice or better multidetector CT (MDCT) angiography of paired grafts (within each patient) at 4\u20136\u2009weeks, 3\u2009months and 12\u2009months. Primary endpoints will be the magnitude of change in mean wall thickness and lumen diameter (stenosis) of paired grafts, at 3 and 12\u2009months, respectively. Besides the evaluation of overall safety, longitudinal assessment of each graft (secondary endpoint) is performed in order to obtain insight into graft behaviour after CABG. Enrolment of 119 patients was successfully completed, and analysis of MDCT angiography follow-up is ongoing with the completed analysis becoming available by end of first quarter of 2018.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The regional ethics committees have approved the trial. Results will be submitted for publication.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial identifier<\/jats:title>\n                  <jats:p>NCT02272582 and <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02774824\">NCT02774824<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/openhrt-2018-000780","type":"journal-article","created":{"date-parts":[[2018,4,13]],"date-time":"2018-04-13T07:35:18Z","timestamp":1523604918000},"page":"e000780","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial"],"prefix":"10.1136","volume":"5","clinical-trial-number":[{"clinical-trial-number":"nct02272582","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02774824","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02272582","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02774824","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Walid","family":"Ben Ali","sequence":"first","affiliation":[{"name":"Department of Surgery, Montreal Heart Institute, Montr\u00e9al, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Voisine","sequence":"additional","affiliation":[{"name":"Institut Universitaire de Cardiologie et de Pneumologie, Quebec City, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter Skov","family":"Olsen","sequence":"additional","affiliation":[{"name":"Dept. of Cardiac Surgery, Rigshopitalet University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hugues","family":"Jeanmart","sequence":"additional","affiliation":[{"name":"H\u00f4pital du Sacr\u00e9-Coeur, Montr\u00e9al, Qu\u00e9bec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Noiseux","sequence":"additional","affiliation":[{"name":"Department of Surgery, Montreal Heart Institute, Montr\u00e9al, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracy","family":"Goeken","sequence":"additional","affiliation":[{"name":"Somahlution Inc, Jupiter, Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vilas","family":"Satishchandran","sequence":"additional","affiliation":[{"name":"Somahlution Inc, Jupiter, Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Filippo","family":"Cademartiri","sequence":"additional","affiliation":[{"name":"Cardiovascular Imaging Service SDN IRCCS, Naples, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Garry","family":"Cutter","sequence":"additional","affiliation":[{"name":"University of Alabama, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dave","family":"Veerasingam","sequence":"additional","affiliation":[{"name":"Galway University Hospital, Galway, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig","family":"Brown","sequence":"additional","affiliation":[{"name":"New Brunswick Heart Centre, Saint John, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maximilian Y","family":"Emmert","sequence":"additional","affiliation":[{"name":"Clinic for Cardiac Surgery, University Hospital Zurich, Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis P","family":"Perrault","sequence":"additional","affiliation":[{"name":"Department of Surgery, Montreal Heart Institute, Montr\u00e9al, 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