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Complication-free survival at 30\u00a0days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis\u2009&lt;\u200930%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Seventy five patients were included. There were 50 (68.0%) males; mean age, 69.0\u2009\u00b1\u200910.7\u00a0years. CLTI severity was based on the Rutherford Scale (R5\u2009=\u200951; R6\u2009=\u200917). Significant co-morbidities included diabetes mellitus (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200968; 91.0%) and end-stage renal failure (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200928; 37.0%). 112 atherosclerotic lesions were treated (TASC II D\u2009=\u200958 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4\u2009\u00b1\u200913.9\u00a0cm. Primary vessel patencies at 6 and 12\u00a0months were 64\/86 (74%) and 43\/74 (58%) and freedom from clinically driven TLR were 72\/86 (84%) and 55\/74 (74%) respectively. AFS was 61\/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1\u2009\u00b1\u20090.55 at baseline to 1.1\u2009\u00b1\u20092.05 (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05) at one year and there was a wound healing rate of 38\/48 (79%) at the same timepoint.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:italic>Selution SLR<\/jats:italic>\n                      \u2122 drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>Level 2b, Individual Cohort Study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical Abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s00270-024-03756-3","type":"journal-article","created":{"date-parts":[[2024,6,19]],"date-time":"2024-06-19T12:03:50Z","timestamp":1718798630000},"page":"863-874","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore \u2013 12 Months Results of the PRISTINE Registry"],"prefix":"10.1007","volume":"47","author":[{"given":"T. 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