Abstract Purpose 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. Methods CALCIO is a worldwide, multicenter, prospective cohort study designed to follow for 2 years 400 participants treated with the Shockwave Medical IVL System. Eligible patients, adults (≥ 18 years) with CLTI (Rutherford category ≥ 4) 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 months. 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. Conclusion 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). Graphical Abstract
Uberoi et al. (Tue,) studied this question.