{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:02:14Z","timestamp":1791975734516,"version":"4.4.0"},"reference-count":25,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2014,2,5]],"date-time":"2014-02-05T00:00:00Z","timestamp":1391558400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"DOI":"10.13039\/501100002736","name":"Covidien","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002736","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2014,8]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>The purpose of the DEFINITIVE Ca<jats:sup>++<\/jats:sup> study was to evaluate the safety and effectiveness of directional atherectomy and distal embolic protection, used together to treat moderate to severely calcified femoropopliteal lesions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Despite advances in endovascular treatment modalities, treatment of calcified lesions remains a challenge.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 133 subjects with 168 moderate to severely calcified lesions were enrolled. Lesions were treated with directional atherectomy devices, coupled with distal embolic protection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 30\u2010day freedom from MAE rate was 93.1%. Per angiographic core laboratory assessment, the primary effectiveness endpoint (\u226450% residual diameter stenosis) was achieved in 92.0% (lower confidence bound of 87.6%) of lesions. By core lab analysis, these results did not achieve the success criteria (90%) for the primary effectiveness objective. Per site assessment, the objective was met with the endpoint being achieved in 97.0% (lower confidence bound 93.8%). A mean residual diameter stenosis of 33.3% was achieved with the directional atherectomy device. This was further decreased to 24.1% with the use of adjunctive therapy. The proportion of asymptomatic subjects [Rutherford Clinical Category (RCC)\u2009=\u20090] increased from 0% at baseline to 52.3% at the 30\u2010day follow\u2010up visit. In total, 88.5% of subjects experienced an improvement of one or more Rutherford categories.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The results of the DEFINITIVE Ca++ study demonstrate that the SilverHawk\u2122 and TurboHawk\u2122 atherectomy devices are safe and effective in the endovascular treatment of moderate to severely calcified lesions in the superficial femoral and\/or popliteal arteries when used with the SpiderFX\u2122 distal embolic protection device. \u00a9 2014 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.25384","type":"journal-article","created":{"date-parts":[[2014,1,9]],"date-time":"2014-01-09T07:01:18Z","timestamp":1389250878000},"page":"236-244","source":"Crossref","is-referenced-by-count":93,"title":["Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca<sup>++<\/sup> trial"],"prefix":"10.1002","volume":"84","author":[{"given":"David","family":"Roberts","sequence":"first","affiliation":[{"name":"Sutter Heart and Vascular Institute Sacramento California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khusrow","family":"Niazi","sequence":"additional","affiliation":[{"name":"Emory University  Atlanta Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Miller","sequence":"additional","affiliation":[{"name":"University of Colorado Health Fort Collins Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prakash","family":"Krishnan","sequence":"additional","affiliation":[{"name":"Mt. 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