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Updated: Feb 19, 2026

Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultrasound

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Linfotricia intravascular para pacientes con isquemia crónica amenazante de extremidad: Protocolo de estudio para

Raman Uberoi¹, Peter Reimer², Joo-Young Chun³

¹Department of Radiology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headington, Oxford, OX3 9DU, UK.

Cardiovascular and interventional radiology

|February 17, 2026

Abstracto

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).

Palabras clave:

isquemia crónica amenazante de extremidad tratamiento endovascular linfotricia intravascular enfermedad arterial periférica calcificación vascular

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