{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T18:12:40Z","timestamp":1793124760328,"version":"4.5.0"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,6,8]],"date-time":"2024-06-08T00:00:00Z","timestamp":1717804800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,6,8]],"date-time":"2024-06-08T00:00:00Z","timestamp":1717804800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12\u00a0months defined as restenosis\u2009&lt;\u200950% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30\u00a0days. Secondary endpoints include primary patency of the target lesion at 6 and 24\u00a0months, secondary patency, cdTLR 6, 12, and 24\u00a0months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24\u00a0months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36\u00a0months.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a \u201cleaving nothing behind\u201d endovascular approach combining directional atherectomy and DCB compared to surgical therapy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT02517827.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08219-1","type":"journal-article","created":{"date-parts":[[2024,6,8]],"date-time":"2024-06-08T09:02:08Z","timestamp":1717837328000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3077-3253","authenticated-orcid":false,"given":"Aljoscha","family":"Rastan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"B\u00f6hme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Zeller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,6,8]]},"reference":[{"key":"8219_CR1","doi-asserted-by":"crossref","unstructured":"Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss L et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF\/AHA Guideline Recommendations): a report of the American College of Cardiology Foundation\/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61:1555\u201370.","DOI":"10.1016\/j.jacc.2013.01.004"},{"key":"8219_CR2","doi-asserted-by":"crossref","unstructured":"Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66:2329\u2013238.","DOI":"10.1016\/j.jacc.2015.09.063"},{"key":"8219_CR3","doi-asserted-by":"crossref","unstructured":"Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Zilver PTX Investigators. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133:1472\u201383.","DOI":"10.1161\/CIRCULATIONAHA.115.016900"},{"key":"8219_CR4","doi-asserted-by":"crossref","unstructured":"Kang JL, Patel VI, Conrad MF, Lamuraglia GM, Chung TK, Cambria RP. Common femoral artery occlusive disease: contemporary results following surgical endarterectomy. J Vasc Surg. 2008;48:872\u20137.","DOI":"10.1016\/j.jvs.2008.05.025"},{"key":"8219_CR5","doi-asserted-by":"crossref","unstructured":"Nguyen BN, Amdur RL, Abugideiri M, Rahbar R, Neville RF, Sidawy, AN. Postoperative complications after common femoral endarterectomy. J Vasc Surg. 2015;61:1489\u201394.","DOI":"10.1016\/j.jvs.2015.01.024"},{"key":"8219_CR6","doi-asserted-by":"crossref","unstructured":"Wieker CM, Sch\u00f6nefeld E, Osada N, L\u00fchrs C, Beneking R, Torsello G, et al. Results of common femoral artery thromboendarterectomy evaluation of a traditional surgical management in the endovascular era. J Vasc Surg. 2016;64:995\u20131001.","DOI":"10.1016\/j.jvs.2016.04.036"},{"key":"8219_CR7","doi-asserted-by":"crossref","unstructured":"Gou\u00ebffic Y, Della Schiava N, Thaveau F, Rosset E, Favre JP, du Mont LS, et al. Stenting or surgery for de novo common femoral artery stenosis. JACC: Cardiovasc. Interv. 2017;10:1344\u201354.","DOI":"10.1016\/j.jcin.2017.03.046"},{"key":"8219_CR8","doi-asserted-by":"crossref","unstructured":"Cioppa A, Stabile E, Salemme L, Popusoi G, Pucciarelli A, Iacovelli F, et al. Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes. EuroIntervention. 2017;12:1789\u201394.","DOI":"10.4244\/EIJ-D-15-00187"},{"key":"8219_CR9","doi-asserted-by":"crossref","unstructured":"Boehme T, Romano L, Macharzina RR, Noory E, Beschorner U, Jacques B, et al. Outcomes of directional atherectomy for common femoral artery disease. Eurointervention. 2021;17:260\u20136.","DOI":"10.4244\/EIJ-D-19-00693"},{"key":"8219_CR10","doi-asserted-by":"crossref","unstructured":"Ranke C, Creutzig A, Alexander K. Duplex scanning of the peripheral arteries: correlation of the peak velocity ratio with angiographic diameter reduction. Ultrasound Med Biol. 1992;18:433\u201340.","DOI":"10.1016\/0301-5629(92)90082-L"},{"key":"8219_CR11","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1016\/S1051-0443(91)72275-6","volume":"2","author":"RB Rutherford","year":"1991","unstructured":"Rutherford RB, Becker GJ. Standards for evaluation and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. JVasc Interv Radiol. 1991;2:169\u201374.","journal-title":"JVasc Interv Radiol"},{"key":"8219_CR12","doi-asserted-by":"crossref","unstructured":"Cioppa A, Stabile E, Popusoi G, Salemme L, Cota L, Pucciarelli A, et al. 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Evaluation of stent angioplasty in the treatment of arteriosclerotic lesions of the common femoral artery. J Clin Med. 2022;11:2694.","DOI":"10.3390\/jcm11102694"},{"key":"8219_CR16","doi-asserted-by":"crossref","unstructured":"Allan R, Puckridge P, Travers E, Delaney C. Early outcomes of interwoven nitinol wire stent placement versus endarterectomy for the treatment of atherosclerotic disease of the common femoral artery. J Vasc Interv Radiol. 2024;35(2):269\u201377.","DOI":"10.1016\/j.jvir.2023.10.024"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08219-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08219-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08219-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,8]],"date-time":"2024-06-08T09:03:54Z","timestamp":1717837434000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08219-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,8]]},"references-count":16,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8219"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08219-1","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,8]]},"assertion":[{"value":"11 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 June 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 June 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study has been approved by the Ethics Committee of the Albert-Ludwigs-Universit\u00e4t Freiburg (Nr. 399\/15 (MPG \u00a723b, dated 12 May 2016)). In addition, the study protocol must be approved by the local ethics committees of all participating sites. The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"A translated consent form is submitted.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"370"}}