{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T18:42:45Z","timestamp":1772131365963,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2015,9,2]],"date-time":"2015-09-02T00:00:00Z","timestamp":1441152000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Scoring balloons produce excellent acute results in the treatment of in\u2010stent restenosis (ISR), fibro\u2010calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel\u2010coated scoring balloon (SB) was developed and tested to overcome this limitation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug\u2010coated or uncoated SB. Baseline and 6\u2010month follow\u2010up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in\u2010segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty\u2010one patients were randomized (28 uncoated and 33 drug\u2010coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6\u2010month angiography, in\u2010segment LLL was 0.48\u2009\u00b1\u20090.51 mm in the uncoated SB group versus 0.17\u2009\u00b1\u20090.40 mm in the drug\u2010coated SB group (<jats:italic>P<\/jats:italic>\u2009=\u20090.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug\u2010coated SB group (<jats:italic>P<\/jats:italic>\u2009=\u20090.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug\u2010coated SB group (<jats:italic>P<\/jats:italic>\u2009=\u20090.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% <jats:italic>P<\/jats:italic>\u2009=\u20090.004).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>A novel paclitaxel\u2010coated coronary SB has been developed and successfully used in a first\u2010in\u2010human randomized controlled trial [<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link> Identifier: NCT01495533]. \u00a9 2015 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.26216","type":"journal-article","created":{"date-parts":[[2015,9,2]],"date-time":"2015-09-02T21:44:08Z","timestamp":1441230248000},"page":"51-59","source":"Crossref","is-referenced-by-count":22,"title":["A novel drug\u2010coated scoring balloon for the treatment of coronary in\u2010stent restenosis: Results from the multi\u2010center randomized controlled 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