{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:36:18Z","timestamp":1753878978515,"version":"3.41.2"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T00:00:00Z","timestamp":1737676800000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Clinical Hypertension"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>This first\u2010in\u2010man (FIM) study evaluated the feasibility and safety of a new peripheral plaque atherectomy system in patients with symptomatic lower extremity artery disease (LEAD). Ten patients with symptomatic LEAD (Rutherford class 2\u20135) were enrolled in a prospective, single\u2010center study from March to April 2024. Patients aged 18\u201385 years with target lesions showing \u226570% stenosis and reference vessel diameters \u22651.8\u00a0mm underwent treatment using a novel atherectomy device with a \u201cshaving\u201d mechanism to excise calcified plaques. Outcomes included post\u2010procedural stenosis improvement, 6\u2010month primary patency rate, and safety endpoints such as thrombosis, vasospasm, acute occlusion, and distal embolization. Statistical analysis used SPSS 23.0. Ten male patients (mean age: 61.4 \u00b1 9.2 years) were treated. Most had diabetes (80%), hypertension (70%), and hyperlipidemia (80%). Pre\u2010procedural ankle\u2010brachial index (ABI) averaged 0.50 \u00b1 0.14. Angiographic analysis showed 60% of lesions in the femoral artery and 40% as chronic total occlusions. No major adverse events occurred, with 100% technical success. Post\u2010procedural ABI improved to 0.92 \u00b1 0.12 (<jats:italic>p<\/jats:italic> &lt; 0.05). At 6 months, the primary patency rate was 100%, with no clinically\u2010driven revascularization or adverse cardiovascular events. Mortality was 0%. All patients reported significant improvement in symptoms and walking distance, as well as enhanced quality of life and reduced pain during physical activity. The novel atherectomy device showed promising safety and efficacy for treating calcified LEAD. Larger\u2010scale trials are needed to confirm these outcomes.<\/jats:p>","DOI":"10.1111\/jch.14967","type":"journal-article","created":{"date-parts":[[2025,1,24]],"date-time":"2025-01-24T08:42:02Z","timestamp":1737708122000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["First\u2010in\u2010Man Study of a Novel Peripheral Plaque Atherectomy Device"],"prefix":"10.1111","volume":"27","author":[{"given":"Hui","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery Xuanwu Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dikang","family":"Pan","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery Xuanwu Hospital Capital Medical University  Beijing 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