{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T14:14:10Z","timestamp":1779804850772,"version":"3.53.1"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T00:00:00Z","timestamp":1771286400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T00:00:00Z","timestamp":1771286400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Shockwave Medical, Inc"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cardiovasc Intervent Radiol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The prevalence of severe vascular calcification in patients with Chronic Limb-Threatening Ischemia (CLTI) hinders the outcome of endovascular interventions and increases the risk of amputation and death. Intravascular lithotripsy (IVL) is a safe and effective treatment that promotes revascularization; however, large-scale data on its long-term effectiveness are lacking. The Chronic Limb-Threatening Ischemia treated with Intravascular Lithotripsy Observational Study (CALCIO) aims to address this shortcoming by assessing the real-world, long-term outcomes of IVL in a large cohort of patients with CLTI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>CALCIO is a worldwide, multicenter, prospective cohort study designed to follow for 2\u00a0years 400 participants treated with the Shockwave Medical IVL System. Eligible patients, adults (\u2265\u200918\u00a0years) with CLTI (Rutherford category\u2009\u2265\u20094) and calcified femoro-popliteal and\/or crural lesions visible on fluoroscopy, are recruited upon providing informed consent. The primary outcome measure is a composite of wound healing and freedom from amputation at 12\u00a0months. Secondary outcome measures include technical success, amputation-free survival, changes in Rutherford category, limb perfusion and wound, ischemia, and foot infection (WIfI) score, patency, need for revascularization, safety, and patient-reported health-related quality of life (HRQoL). Results will be reported using mainly descriptive statistics. Patient enrollment opened in July 2024 and is planned to continue until July 2026, with the follow-up period expected to end in July 2028.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>CALCIO intends to provide valuable insights into the real-world long-term clinical outcomes of IVL to support decision making regarding the optimal endovascular treatment for CLTI patients. CALCIO is registered on ClinicalTrials.gov (NCT06149650).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00270-025-04335-w","type":"journal-article","created":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T22:11:03Z","timestamp":1771366263000},"page":"1219-1226","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a Prospective Multicenter Observational Investigation"],"prefix":"10.1007","volume":"49","author":[{"given":"Raman","family":"Uberoi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Reimer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joo-Young","family":"Chun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Goyault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elika","family":"Kashef","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romaric","family":"Loffroy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Rand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Antonella","family":"Ruffino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrad","family":"von Stempel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tilmann","family":"Lange","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bleranda","family":"Zeka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1063-5830","authenticated-orcid":false,"given":"Claire","family":"Poulet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Kaufmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Binkert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,17]]},"reference":[{"issue":"36","key":"4335_CR1","doi-asserted-by":"publisher","first-page":"3538","DOI":"10.1093\/eurheartj\/ehae179","volume":"45","author":"L Mazzolai","year":"2024","unstructured":"Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, et al. 2024 ESC guidelines for the management of peripheral arterial and aortic diseases. 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