New CIRSE clinical research project: CALCIO
CIRSE is very pleased to announce the addition of a new research project scientifically sponsored by the Society to its portfolio. CALCIO, the CriticAl Limb isChemia treated with Intravascular lithotripsy Observational study, marks CIRSE’s first venture into endovascular research.
The initiators of the project are Prof. Christoph Binkert (Winterthur Cantonal Hospital, Winterthur, CH), Dr. Raman Uberoi (John Radcliffe Hospital, Oxford, UK) and Prof. Peter Reimer (Karlsruhe Municipal Hospital, DE), who will be acting as coordinating investigators and will co-chair the CALCIO steering committee to provide scientific guidance during the whole course of the study.
CALCIO initiators Prof. Binkert, Dr. Uberoi, and Prof. Reimer.
CIRSE: Can you tell us a bit more about this exciting new project?
Uberoi: CALCIO is a European, single-arm, 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 calcification in patients with critical limb ischemia (CLI). This is a hugely important and growing area in peripheral arterial disease (PAD) where the outcome of current endovascular treatments are limited by the presence of vascular calcifications, which are often present in CLI patients and IVL by softening calcified plaque has the potential to significantly improve results.
Binkert: The primary objective of the study is to understand the long-term clinical effectiveness of IVL for patients with CLI by looking at wound healing, occurrence of amputation and amputation-free survival over a follow-up period of 2 years. As a secondary objective, CALCIO will evaluate the immediate technical results of the treatment by recording the residual stenosis, the need for adjunctive treatments and the occurrence of complications.
Reimer: At the moment, we are finalising organisational aspects of the study. In the upcoming months, we will be reaching out to colleagues about participation. Patient recruitment is then planned to start early next year. Overall, we will aim to recruit 400 patients during the 2-year enrolment phase.
CIRSE: What motivated you to initiate CALCIO?
Binkert: 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.
Reimer: The insights we gain from this project will be invaluable as they will complement our clinical practice and treatment strategies for patients with CLI. Important questions will be answered, such as: to which extent does IVL improve clinical outcomes? Can stents be avoided?
Uberoi: 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.
As for previous studies scientifically sponsored by CIRSE, clinical project management is delegated to CIRSE’s contract research organization, Next Research.
To learn more about the project, please click here or reach out to [email protected]