{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T01:13:14Z","timestamp":1777943594705,"version":"3.51.4"},"reference-count":26,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2017,9,27]],"date-time":"2017-09-27T00:00:00Z","timestamp":1506470400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Vascular"],"published-print":{"date-parts":[[2017,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis \u226450% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117\/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of \u226586%. After post-atherectomy adjunctive therapy, residual stenosis was \u226430% for 99.2% (122\/123) of lesions (mean final diameter stenosis 10.5%). Improvement of \u22651 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6\/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of &lt;20%), and 16.8% through six months. Six-month freedom from TLR and TVR was 88.0% and 86.1%, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Based on the high rate of technical success and the low rates of MAEs through six months, the Phoenix Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1708538117712383","type":"journal-article","created":{"date-parts":[[2017,9,27]],"date-time":"2017-09-27T04:57:07Z","timestamp":1506488227000},"page":"563-575","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":45,"title":["Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study"],"prefix":"10.1177","volume":"25","author":[{"given":"Thomas","family":"Davis","sequence":"first","affiliation":[{"name":"Interventional Cardiology, St. John Hospital and Medical Center, Detroit, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Venkatesh","family":"Ramaiah","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Arizona Heart Institute, Phoenix, AZ, 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