{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T18:10:32Z","timestamp":1773425432525,"version":"3.50.1"},"reference-count":30,"publisher":"Hogrefe Publishing Group","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vasa"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:p>Summary: Background: The aim was to evaluate the safety and efficacy of a high pressure, non-compliant balloon in the treatment of infrapopliteal occlusive disease in Asian patients with chronic limb threatening ischaemia (CLTI) from Singapore. Patients and methods: Prospective, multi-centre, single arm, non-randomized study. Immediate technical success, 6-month primary vessel patency (determined by Duplex ultrasonography), limb salvage, one-year clinically driven target lesion re-intervention (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. Results: 86 patients (63% males, mean age 68.9\u00a0\u00b1\u00a09.9\u00a0years) were enrolled over a 15-month period. Diabetes mellitus (DM) and end-stage renal failure (ESRF) were present in 94% and 38% of patients respectively. All had some degree of tissue loss at baseline (Rutherford scale 5 and 6\u00a0=\u00a091% and 9% respectively). Of the 86 legs, 72% had 3 crural vessel disease and 84% had moderate\/severe vessel wall calcification. 90% had\u00a0&gt;\u00a0=\u00a01 TASC D tibial lesion. Acute technical success was 89%. One month mortality was 3.5% and one-year freedom from TLR was 91%. 6-month tibial patency was 73%. 54\/66 (82%) patients had at least one target treated tibial artery open at 6 months. A lower baseline toe pressure (OR 1.03, 95%CI 1.00\u20131.05) and elastic recoil post angioplasty (OR 0.20, 95%CI 0.05\u20130.79) were associated with a worse 6 month tibial patency. One-year AFS was 67%. 47\/66 (71%) patients had a clinical improvement of at least one Rutherford class at 6 months and 52\/59 (88%) experienced complete wound healing at 12 months. Conclusions: Use of a high pressure non-compliant balloon is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging population of CLTI patients with a high incidence of DM and ESRF. It is associated with highly satisfactory acute technical success, 6-month target lesion patency and one-year limb salvage.<\/jats:p>","DOI":"10.1024\/0301-1526\/a000888","type":"journal-article","created":{"date-parts":[[2020,7,22]],"date-time":"2020-07-22T07:13:22Z","timestamp":1595402002000},"page":"475-482","source":"Crossref","is-referenced-by-count":3,"title":["Utility of a novel high pressure non-compliant balloon for tibial atherosclerotic lesions in Asian patients with chronic limb threatening ischaemia"],"prefix":"10.1024","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8524-7912","authenticated-orcid":true,"given":"Tjun Yip","family":"Tang","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery, Singapore General Hospital, Singapore"},{"name":"Duke-NUS Graduate Medical School, Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaun Qing Wei","family":"Lee","sequence":"additional","affiliation":[{"name":"Department 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