CriticAl Limb isChemia treated with Intravascular Lithotripsy Observational Study
Status: enrolling
CALCIO
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 prospective, observational cohort study that is collecting real-world data on the use of intravascular lithotripsy (IVL) with the Shockwave Medical IVL system (Shockwave Medical, Inc.) to disrupt vascular calcifications in patients with chronic limb-threatening ischemia (CLTI) with calcified femoropopliteal or crural lesions visible on fluoroscopy.
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 from Europe and North America and is intended to last 4 years from the start of the patient’s enrolment until the end of the follow-up period.
The project is funded by an independent research grant provided by Shockwave Medical.
Objectives and outcome measures
The primary objective of CALCIO is to understand the clinical effectiveness of IVL in promoting wound healing and preventing amputation in CLTI patients with calcified femoropopliteal or crural lesions.
The primary outcome measure is a composite of wound healing, and freedom from amputation of the treated limb, assessed 12 months after IVL.
As secondary objectives, CALCIO aims to evaluate the effectiveness of IVL in improving clinical symptoms of CLTI, the immediate technical results of IVL, as well as the long-term effectiveness in restoring patency of the target lesion, safety and the impact of the procedure on patient health-related quality of life.
Some secondary outcome measures CALCIO will assess are; wound healing at 24 months, freedom from amputation at 24 months, amputation-free survival, as well as primary and secondary patency rates at 12 and 24 months.
Patient Enrolment
Patient enrolment started in August 2024 and will continue until August 2026, with a maximum follow-up period of two years. Participating centres are selected from several countries in Europe and North America based on their expertise in the management of CLTI patients and their experience with the Shockwave Medical IVL system.
Steering committee
CALCIO is governed by a Steering Committee (SC) consisting of experts in the field of peripheral artery disease (PAD). Chaired by the coordinating investigators Dr. Raman Uberoi, Prof. Christoph Binkert and Prof. Peter Reimer; the SC is responsible for all scientific matters related to the study and oversees all publications.
| Name | Hospital | ||
|---|---|---|---|
| Raman Uberoi (co-chairperson) | John Radcliffe Hospital/UK | ||
| Christoph Binkert (co-chairperson) | University of Zürich/CH | ||
| Peter Reimer (co-chairperson) | Municipal Clinic Karlsruhe/DE | ||
| Thomas Albrecht | Vivantes Klinikum Neukölln/DE | ||
| Enrique Alejandre-Lafont | Kantonsspital St.Gallen/CH | ||
| Gilles Goyault | Clinique Rhena de Strasbourg/FR | ||
| Elika Kashef | Imperial College NHS Trust/UK | ||
| Thomas Rand | Klinikum Floridsdorf/AT | ||
| Maria Antonella Ruffino | Ente Ospedaliero Cantonale/CH | ||
| Dimitrios Tsetis† | University Hospital of Heraklion/GR | ||
| † Prof. Tsetis sadly passed away in June 2024. | |||
Press release
CALCIO Enrolment has started! (https://www.cirse.org/publications/cirse-insider/calcio-enrolment-has-started/)