CIRSE Begins CALCIO Study of the Treatment of CLTI With Shockwave IVL

July 31, 2024—The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) announced that patient enrollment in the CALCIO study commenced on July 15, 2024.

In the CALCIO study, Professor Peter Reimer, MD, and Professor Christoph Binkert, MD, aim to understand the clinical effectiveness of intravascular lithotripsy (IVL) in promoting wound healing and preventing amputation in chronic limb-threatening ischemia (CLTI) patients with calcified femoropopliteal or crural lesions, stated CIRSE.

CALCIO was initiated by study co-chair Raman Uberoi, MD.

Prof. Reimer is from Klinikum Karlsruhe in Karlsruhe, Germany. Prof. Binkert is from MRI Bahnhof Oerlikon in Zurich, Switzerland. Dr. Uberoi is from Oxford University Hospital in Oxford, the United Kingdom.

According to CIRSE, the CALCIO study’s recruitment goal is 400 patients with CLTI. Patients will be enrolled during the next 2 years and treated with the Shockwave IVL system (Shockwave Medical, Inc., part of Johnson & Johnson MedTech). When patient enrollment is complete, an additional 2 years will be dedicated to the collection of patient follow-up data to ensure the study meets its objectives.

Currently, there are several sites enrolled from Germany and the United Kingdom. More centers from Germany, the United Kingdom, France, Austria, Italy, Greece, and Canada are in the recruitment process and are expected to join the study soon, advised CIRSE.

“CALCIO is a really important study looking at how we can improve outcomes for CLTI patients,” commented Dr. Uberoi in the CIRSE press release. “This is a really difficult patient group to manage and treat with multilevel disease, but even more importantly, they have a disease that has a high calcific element. This is where the therapy with the Shockwave IVL system will potentially enhance and improve patient outcomes. Come and join us for this important study!”

Prof. Binkert added, “I think CALCIO is a very important registry because it collects real-world data on a very severe problem, as patients with CLTI need to get revascularization and if they have very calcified arteries, this is a big challenge, and the current evidence is not sufficient.”

The press release advised that CALCIO is scientifically sponsored by CIRSE; designed and run by Next Research, a contract research organization; and funded by Shockwave Medical through a sponsored research agreement.

More information on the CALCIO study is available online at the CIRSE website, here; at the FDA’s Clinical Trials Registry database, here; or by contacting Claire Poulet at Next Research, calcio@cirse.org.