CriticAl Limb isChemia treated with Intravascular lithotripsy Observational study
Status: in design
CALCIO
The treatment of calcified lesions remains one of the most challenging issues when managing patients with CLI. 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 CLI, 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 CLI.
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 critical limb ischemia (CLI).
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.
Endpoints
The primary objective of CALCIO is to understand the long-term clinical effectiveness of IVL for patients with CLI 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.