Cardiovascular and Interventional Radiological Society of Europe


Chronic Limb-threatening Ischemia treated with Intravascular Lithotripsy Observational Study

Status: in design

The treatment of calcified lesions remains one of the most challenging issues when managing patients with CLTI. We hope CALCIO will demonstrate the benefits of using IVL where other technologies have failed.
CALCIO is the first study on IVL that focuses on patients with CLTI, and that will look primarily at hard clinical outcomes directly reflecting patients’ quality of life: limb salvage and amputation-free survival.
The insights we gain from this project will be invaluable as they will complement our clinical practice and treatment strategies for patients with CLTI.

Study Summary

CALCIO is a Europe-wide, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system (Shockwave Medical, Inc.) to disrupt vascular calcifications in patients with chronic limb-threatening ischemia (CLTI).

The principle of IVL is to deliver shockwaves within calcified vessels to break calcium deposits, thereby softening the calcified plaque and potentially improving the outcome of subsequent endovascular treatments.

CALCIO aims to recruit 400 patients during the 2-year enrolment phase which is planned to start in early 2024.

The project is funded by an independent research grant provided by Shockwave Medical.


The primary objective of CALCIO is to understand the long-term clinical effectiveness of IVL for patients with CLTI by looking at the following criteria for a period of 2 years:

  • Wound healing
  • Occurrence of amputation
  • Amputation-free survival

As a secondary objective, CALCIO aims to evaluate the immediate technical results of the procedure by monitoring the following parameters:

  • Residual Stenosis
  • Need for adjunctive treatment(s)
  • Occurrence of complications

Other secondary endpoints of CALCIO include to assess the impact of the procedure on patients’ quality of life and pain over the total duration of the follow-up period.