Clinical Trial

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Study acronym: CALCIO
Active, Not Recruiting
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Summary
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.
Protocol Amendment History 1 change
critical Enrollment closed, study ongoing 2026-07-31
Trial Details
NCT Number NCT06149650
Lead Sponsor Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Shockwave Medical, Inc.
Conditions Chronic Limb-Threatening Ischemia
Enrollment 400 participants
Start Date 2024-07-15
Primary Completion 2028-07-15 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30