Chronic Limb-Threatening Ischemia treated with Intravascular Lithotripsy Observational Study (CALCIO)

Research summary

Peripheral artery disease (PAD) is a reduction of blood flow in the legs due to the narrowing or blockage of arteries. The prevalence of vascular calcification in patients with PAD hinders the outcome of endovascular treatments due to increased stiffness of the vessel wall. Treatment failure is especially high in patients with chronic limb-threatening ischemia (CLTI), the most advanced type of PAD, characterized by rest pain and tissue loss. These patients are at a high risk of limb amputation and death, a prognosis that is worsen by severe calcification. With intravascular lithotripsy (IVL), shockwaves are delivered directly within a calcified narrowed or blocked vessel to disrupt calcification and bring back elasticity to the vessel wall which helps to restore blood flow. The safety and immediate effectiveness of IVL have been repeatedly demonstrated in patients with early stages of PAD. However large-scale data on its long-term effectiveness, especially in patients with CLTI is still lacking. In this context, CALCIO aims at expending our understanding of IVL for the management of patients with CLTI by primarily looking at its long-term effectiveness and impact on quality-of-life. CACLIO is a prospective, international, multicentre, single-arm observational study with the objective to follow for 2 years 400 CLTI patients treated with the Shockwave Medical IVL System. Effectiveness of IVL will be primarily assessed at twelve months using a composite outcome measure of wound healing and freedom from amputation which both directly reflect patient quality-of-life. Secondary effectiveness outcome measures include procedural success, patency rate, freedom from clinically-driven target lesion revascularization and clinical response. Patient-reported health-related quality-of-life will be assessed using the EuroQol EQ-5D-5L questionnaire. Overall, CALCIO intends to provide healthcare professionals and health authorities with information on IVL for patients with CLTI to help decision-making processes regarding treatment access and reimbursement and thereby optimize patient care.

Principal Investigator

Dr Raman Uberoi

Contact us

Email: crndirectdeliveryteam@ouh.nhs.uk

IRAS number

337266