{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T02:10:46Z","timestamp":1740103846946,"version":"3.37.3"},"reference-count":29,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T00:00:00Z","timestamp":1664409600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The OPEN study evaluated the safety and efficacy of the S.M.A.R.T.\u00ae Flex Vascular Stent System in patients with femoropopliteal arterial disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Long\u2010term data on endovascular treatments of femoropopliteal arterial disease are required to establish the repair durability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The OPEN study was a multicenter, single\u2010arm, prospective study comparing primary safety and efficacy outcomes to performance goals (PG) developed for bare nitinol stents. Patients with symptoms due to a single, \u2264180\u2009mm length, de novo femoropopliteal arterial lesion with &gt;70% stenosis were enrolled and followed for 36 months. Subjects with lesions \u2264150\u2009mm served as the initial comparison cohort for the PG (other cohorts were analyzed if the PG was met).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>257 subjects with lesions \u2264180\u2009mm were enrolled. The mean lesion length was 71\u2009\u00b1\u200946\u2009mm, and 52.5% had severe claudication. The primary safety endpoint (freedom from all\u2010cause death, index limb amputation, and target lesion revascularization [TLR] through 30 days) was met in 98.8% (96.5%, 99.6%)\u00a0of subjects in the comparison cohort, meeting the PG (88.0%). The primary efficacy endpoint (comparison cohort vessel patency at 12 months) was 68.4% (61.1%, 74.8%), where the lower limit of the 95% confidence interval did not meet the 66.0% PG. Freedom from TLR in the per\u2010protocol cohort at 12\u2010, 24\u2010, 36\u2010month\u00a0was 84.7%, 74.6%, and 72.8%, respectively. The 24\u2010month stent fracture rate was 4.3%, with no new fractures identified at 36 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The results show promising long\u2010term safety and effectiveness for the S.M.A.R.T.\u00ae Flex Vascular Stent System in patients with femoropopliteal arterial disease.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30414","type":"journal-article","created":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T06:24:39Z","timestamp":1664519079000},"page":"1078-1087","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of safety and efficacy of the S.M.A.R.T.\u00ae Flex Vascular Stent System (OPEN study)"],"prefix":"10.1002","volume":"100","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4676-2839","authenticated-orcid":false,"given":"William A.","family":"Gray","sequence":"first","affiliation":[{"name":"Main Line Health Lankenau Heart Institute  Wynnewood Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Cardenas","sequence":"additional","affiliation":[{"name":"Yuma Regional Medical Center  Yuma Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corey L.","family":"Teigen","sequence":"additional","affiliation":[{"name":"Sanford Clinic Broadway  Fargo North Dakota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,9,29]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2017.01.071"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/1526602816669135"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.3400\/avd.ra.18-00001"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67704-5"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2010.01.073"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/1358863X07079823"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/15266028060130S207"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1583\/05-1672.1"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.05.079"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2012.12.066"},{"key":"e_1_2_9_12_1","first-page":"387","article-title":"Supera self\u2010expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence","volume":"11","author":"Bishu K","year":"2015","journal-title":"Vasc Health Risk Manag"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0741-5214(98)70034-5"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21104"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2019.01.014"},{"issue":"135","key":"e_1_2_9_16_1","first-page":"e686","article-title":"AHA\/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary:\u00a0a\u00a0report of the American College of Cardiology\/American Heart Association Task Force on clinical practice guidelines","volume":"2017","author":"Gerhard\u2010Herman MD","year":"2016","journal-title":"Circulation"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1583\/JEVT-12-3898R.1"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/1526602819895996"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/1526602817749242"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvir.2014.09.018"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.688341"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051303"},{"key":"e_1_2_9_23_1","first-page":"Cd006767","article-title":"Angioplasty versus bare metal stenting for superficial femoral artery lesions","volume":"2014","author":"Chowdhury MM","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.23064"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1177\/1526602817725062"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2019.09.006"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2011.03.272"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.113.000937"},{"key":"e_1_2_9_29_1","first-page":"1386","article-title":"Paclitaxel\u2010eluting balloon versus standard balloon angioplasty in in\u2010stent restenosis of the superficial femoral and proximal popliteal artery: 1\u2010year results of the PACUBA trial","volume":"9","author":"Kinstner CM","year":"2016","journal-title":"Circ\u00a0Cardiovasc\u00a0Interv"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2011.01.047"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.30414","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.30414","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.30414","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T16:47:59Z","timestamp":1692463679000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.30414"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,29]]},"references-count":29,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,11]]}},"alternative-id":["10.1002\/ccd.30414"],"URL":"https:\/\/doi.org\/10.1002\/ccd.30414","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"type":"print","value":"1522-1946"},{"type":"electronic","value":"1522-726X"}],"subject":[],"published":{"date-parts":[[2022,9,29]]},"assertion":[{"value":"2022-03-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}