{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T23:29:36Z","timestamp":1780356576292,"version":"3.54.1"},"reference-count":15,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2019,1,10]],"date-time":"2019-01-10T00:00:00Z","timestamp":1547078400000},"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":[[2019,2]]},"abstract":"<jats:p>Purpose: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease. Methods: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-\u00b5m paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1\u00b110.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0\u00b141.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2\u00b141.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2\u00b130.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0\u00b139.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio \u22652.4 on duplex or &gt;50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. Results: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses &gt;50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%. Conclusion: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.<\/jats:p>","DOI":"10.1177\/1526602818823557","type":"journal-article","created":{"date-parts":[[2019,1,11]],"date-time":"2019-01-11T03:19:09Z","timestamp":1547176749000},"page":"26-30","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry"],"prefix":"10.1177","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9125-8813","authenticated-orcid":false,"given":"Eugenio","family":"Stabile","sequence":"first","affiliation":[{"name":"Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donato","family":"Gerardi","sequence":"additional","affiliation":[{"name":"Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Magliulo","sequence":"additional","affiliation":[{"name":"Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Drago","family":"Zhelev","sequence":"additional","affiliation":[{"name":"Vascular Surgery Clinic, UMBAL Sv. Georgi EAD, Plovdiv, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vassil","family":"Chervenkoff","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery and Angiology, Tokuda Hospital, Sofia, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Taeymans","sequence":"additional","affiliation":[{"name":"Vascular Clinic, ZNA Hospital Stuivenberg, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doncho","family":"Kotasov","sequence":"additional","affiliation":[{"name":"Vascular Surgery Clinic, UMBAL Sv. Georgi EAD, Plovdiv, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Goverde","sequence":"additional","affiliation":[{"name":"Vascular Clinic, ZNA Hospital Stuivenberg, Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Giugliano","sequence":"additional","affiliation":[{"name":"Coronary Care Unit, Clinica Montevergine, Mercogliano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0701-6449","authenticated-orcid":false,"given":"Bruno","family":"Trimarco","sequence":"additional","affiliation":[{"name":"Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Esposito","sequence":"additional","affiliation":[{"name":"Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,1,10]]},"reference":[{"key":"bibr1-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehx095"},{"key":"bibr2-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv204"},{"key":"bibr3-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.05.008"},{"key":"bibr4-1526602818823557","first-page":"327","volume":"54","author":"de Vries JP","year":"2013","journal-title":"J Cardiovasc Surg (Torino)"},{"key":"bibr5-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1177\/1526602817725062"},{"key":"bibr6-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.09.036"},{"key":"bibr7-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2008.06.020"},{"key":"bibr8-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.032235"},{"key":"bibr9-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2013.06.081"},{"key":"bibr10-1526602818823557","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV7SKA14"},{"key":"bibr11-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2013.05.022"},{"key":"bibr12-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1406235"},{"key":"bibr13-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.114.011004"},{"key":"bibr14-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0706356"},{"key":"bibr15-1526602818823557","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2013.11.020"}],"container-title":["Journal of Endovascular Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1526602818823557","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1526602818823557","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1526602818823557","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T21:28:20Z","timestamp":1777498100000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1526602818823557"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,10]]},"references-count":15,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,2]]}},"alternative-id":["10.1177\/1526602818823557"],"URL":"https:\/\/doi.org\/10.1177\/1526602818823557","relation":{},"ISSN":["1526-6028","1545-1550"],"issn-type":[{"value":"1526-6028","type":"print"},{"value":"1545-1550","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1,10]]}}}