{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T01:25:46Z","timestamp":1783041946198,"version":"3.54.6"},"reference-count":37,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2017,7,12]],"date-time":"2017-07-12T00:00:00Z","timestamp":1499817600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Endovasc Ther"],"published-print":{"date-parts":[[2017,10]]},"abstract":"<jats:p>Purpose: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and\/or external iliac arteries. Methods: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more \u201creal-world\u201d patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66\u00b19.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C\/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months. Results: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects. Conclusion: The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice.<\/jats:p>","DOI":"10.1177\/1526602817720463","type":"journal-article","created":{"date-parts":[[2017,9,19]],"date-time":"2017-09-19T06:36:07Z","timestamp":1505802967000},"page":"629-637","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":66,"title":["Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease"],"prefix":"10.1177","volume":"24","author":[{"given":"Jean","family":"Bismuth","sequence":"first","affiliation":[{"name":"DeBakey Heart & Vascular Center, Houston Methodist Hospital, Houston, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce H.","family":"Gray","sequence":"additional","affiliation":[{"name":"University of South Carolina School of Medicine, Greenville, SC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Holden","sequence":"additional","affiliation":[{"name":"Auckland University School of Medicine, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Metzger","sequence":"additional","affiliation":[{"name":"Wellmont CVA Heart Institute, Kingsport, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Panneton","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School, Norfolk, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the VBX FLEX Study Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,7,12]]},"reference":[{"key":"bibr1-1526602817720463","doi-asserted-by":"publisher","DOI":"10.2217\/ica.12.86"},{"key":"bibr2-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31828b82aa"},{"key":"bibr3-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1177\/1526602815592206"},{"key":"bibr4-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2006.12.037"},{"key":"bibr5-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2014.12.009"},{"key":"bibr6-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25505"},{"key":"bibr7-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-013-0741-9"},{"key":"bibr8-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehr211"},{"key":"bibr9-1526602817720463","first-page":"7","volume":"48","author":"Bosiers M","year":"2007","journal-title":"J Cardiovasc Surg (Torino)"},{"key":"bibr10-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2008.09.001"},{"key":"bibr11-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1583\/JEVT-12-3941MR.1"},{"key":"bibr12-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvir.2015.04.007"},{"key":"bibr13-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1148\/radiology.217.1.r00se0595"},{"key":"bibr14-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2011.06.097"},{"key":"bibr15-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2015.06.218"},{"key":"bibr16-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvir.2010.02.032"},{"key":"bibr17-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1177\/1708538114568479"},{"key":"bibr18-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2016.02.064"},{"key":"bibr19-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-13-215"},{"key":"bibr20-1526602817720463","first-page":"117","volume":"12","author":"Aggarwal V","year":"2016","journal-title":"Vasc Health Risk Manag"},{"key":"bibr21-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2014.12.027"},{"key":"bibr22-1526602817720463","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2012.09.002"},{"key":"bibr23-1526602817720463","unstructured":"FDA Manufacturer and User Facility Device Experience. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm. 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