{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T17:14:34Z","timestamp":1773162874832,"version":"3.50.1"},"reference-count":31,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:sec>\n            <jats:title>Background\u2014<\/jats:title>\n            <jats:p>Reintervention in the femoropopliteal artery is frequent and a major driver of cost-effectiveness. High wall shear generated by swirling blood flow is associated with reduced occurrence of atherosclerosis and restenosis. This trial investigated the clinical and hemodynamic outcomes of the BioMimics 3D self-expanding tubular nitinol stent with helical centerline geometry compared with a straight stent in the femoropopliteal artery.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods and Results\u2014<\/jats:title>\n            <jats:p>\n              In a prospective, multicenter, randomized controlled trial, 76 patients with symptomatic peripheral arterial disease were randomized 2:1 to receive a helical or a straight stent. An independent core laboratory adjudicated angiographic and ultrasound parameters. The primary safety end point was freedom from a composite of all death, target limb amputation, and target lesion revascularization at 30 days. The primary effectiveness end point was freedom from clinically driven target lesion revascularization at 6 months. Patency was a secondary end point. Subjects were followed up for 2 years from intervention. The primary safety (1-sided\n              <jats:italic>P<\/jats:italic>\n              &lt;0.01) and efficacy (1-sided\n              <jats:italic>P<\/jats:italic>\n              &lt;0.001) end points for the helical stent were met. The proportion of patients treated with the helical stent who maintained patency at 12 and 24 months was 80% and 72%, respectively, compared with 71% and 55% for the control group. The difference was significant through 24 months (\n              <jats:italic>P<\/jats:italic>\n              =0.05). Freedom from clinically driven target lesion revascularization for the helical compared with straight stent was 91% versus 92% at 12 months and 91% versus 76% at 24 months.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions\u2014<\/jats:title>\n            <jats:p>Both groups had similar safety outcomes and clinically driven target lesion revascularization to 2 years. However, after placement of a BioMimics 3D helical stent, there was improved patency to 2 years.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial Registration\u2014<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              . Unique identifier: NCT02163863.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circinterventions.115.002930","type":"journal-article","created":{"date-parts":[[2016,5,23]],"date-time":"2016-05-23T07:50:35Z","timestamp":1463989835000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":36,"title":["Helical Centerline Stent Improves Patency"],"prefix":"10.1161","volume":"9","author":[{"given":"Thomas","family":"Zeller","sequence":"first","affiliation":[{"name":"From the Department of Angiology, Universit\u00e4ts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter A.","family":"Gaines","sequence":"additional","affiliation":[{"name":"From the Department of Angiology, Universit\u00e4ts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary M.","family":"Ansel","sequence":"additional","affiliation":[{"name":"From the Department of Angiology, Universit\u00e4ts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colin G.","family":"Caro","sequence":"additional","affiliation":[{"name":"From the Department of Angiology, Universit\u00e4ts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.)."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/1358863X08089277"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1308\/003588411X571999"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1308\/003588414X13814021676756"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21104"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-012-0492-z"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.689141"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.109.903468"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051303"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1098\/rspa.1996.0011"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000066914.95878.6D"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1038\/2231159a0"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1161\/ATVBAHA.108.166736"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1098\/rsif.2008.0417"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/circ.118.suppl_18.S_1054"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0706356"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.735985"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1583\/11-3627.1"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2006.12.022"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1067\/mva.2000.106424"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2010.09.020"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.9195"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00047.2009"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.21.2035"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1067\/mva.2001.116804"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1053\/euhj"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.91.12.2995"},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000018282.32332.13"},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9290(00)00066-X"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2006.10.028"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.1098\/rsif.2013.0578"},{"key":"e_1_3_4_32_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.23064"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.115.002930","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T02:22:20Z","timestamp":1715566940000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.115.002930"}},"subtitle":["Two-Year Results From the Randomized Mimics Trial"],"short-title":[],"issued":{"date-parts":[[2016,6]]},"references-count":31,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2016,6]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.115.002930"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.115.002930","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6]]},"assertion":[{"value":"2015-07-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-04-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-05-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e002930"}}