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Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a

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
PubMed

Insights

The CALCIO study will assess long-term outcomes of intravascular lithotripsy (IVL) for Chronic Limb-Threatening Ischemia (CLTI). This research aims to improve endovascular treatment decisions for patients with severe vascular calcification.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Endovascular Therapy

Background:

  • Severe vascular calcification in Chronic Limb-Threatening Ischemia (CLTI) complicates endovascular interventions, increasing amputation and mortality risks.
  • Intravascular lithotripsy (IVL) shows promise for revascularization in CLTI, but long-term effectiveness data are limited.

Purpose of the Study:

  • To evaluate the real-world, long-term outcomes of IVL in a large cohort of CLTI patients.
  • To assess the effectiveness of IVL in improving wound healing and preventing amputation.
  • To provide data supporting optimal endovascular treatment strategies for CLTI.

Main Methods:

  • The worldwide, multicenter, prospective CALCIO observational study will follow 400 adult CLTI patients (Rutherford category ≥4) treated with IVL.
  • Primary outcome: composite of wound healing and freedom from amputation at 12 months.
  • Secondary outcomes include technical success, amputation-free survival, limb perfusion, WIfI score, patency, revascularization rates, safety, and HRQoL.

Main Results:

  • Data collection is ongoing, with enrollment from July 2024 to July 2026 and follow-up through July 2028.
  • Results will be primarily reported using descriptive statistics.
  • The study is registered on ClinicalTrials.gov (NCT06149650).

Conclusions:

  • The CALCIO study is expected to yield significant insights into the long-term clinical efficacy of IVL for CLTI.
  • Findings will aid clinicians in making informed decisions regarding endovascular treatment for CLTI patients with severe calcification.
Abstract

Keywords:
Chronic limb-threatening ischemiaEndovascular treatmentIntravascular lithotripsyPeripheral arterial diseaseVascular calcification

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