Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
Key facts
- Who runs it
- Cardiovascular and Interventional Radiological Society of Europe
- Where
- Austria, Canada, France, Germany, Hungary, Spain, Switzerland, and United Kingdom39 sites in 8 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 400 people, planned
- Started
- 15 Jul 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Observational
- Treatments tested
- Shockwave Medical IVL System
- Record updated
- 30 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)
- Femoropopliteal and/or crural calcified lesions visible on fluoroscopy
- Treatment with IVl using the Shockwave Medical IVL System
Who cannot take part
- Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment
- < 18 years old
- Incapacity or refusal to give informed consent
- Ongoing pregnancy
This trial has no sites in United States.
It has sites in 8 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Full cohort
Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
Treatment: Shockwave Medical IVL System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Publications
- Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a Prospective Multicenter Observational Investigation.Cardiovascular and interventional radiology, 2026
- Record updated
- 30 July 2026