{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:05:50Z","timestamp":1787223950195,"version":"build-2736575974"},"reference-count":27,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2016,11,21]],"date-time":"2016-11-21T00:00:00Z","timestamp":1479686400000},"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":[[2017,2]]},"abstract":"<jats:p>Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and\/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length \u2264110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months. Conclusion: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.<\/jats:p>","DOI":"10.1177\/1526602816680570","type":"journal-article","created":{"date-parts":[[2016,11,21]],"date-time":"2016-11-21T21:05:13Z","timestamp":1479762313000},"page":"11-18","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":27,"title":["First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease"],"prefix":"10.1177","volume":"24","author":[{"given":"Andrew","family":"Holden","sequence":"first","affiliation":[{"name":"Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Merrilees","sequence":"additional","affiliation":[{"name":"Department 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