An observational study in Chronic Limb-Threatening Ischemia, sponsored by Cardiovascular and Interventional Radiological Society of Europe. Active, not recruiting at 39 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Cardiovascular and Interventional Radiological Society of Europe · Observational
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.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 400 is above the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Cardiovascular and Interventional Radiological Society of Europe is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
Device: Shockwave Medical IVL System
Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.
Wound healing and freedom from amputation
Composite of wound healing defined as the healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) and freedom from amputation defined as the absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).
Time frame: 12 months
Wound healing
Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)
Time frame: 24 months
Freedom from amputation
Absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).
Time frame: 24 months
Amputation-free survival
time between IVL treatment and amputation of the target limb, minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure)
Time frame: through study completion, approximately 2 years
Change in Rutherford classification category
Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)
Time frame: 12 and 24 months
Change in foot ischemia
Change in ankle-brachial index or toe pressure, depending on which data is available
Time frame: 12 and 24 months
Change in WIfi score
Three-digit score for comprehensive assessment of wound, ischemia and foot infection
Time frame: 12 and 24 months
Freedom from clinically-driven target lesion revascularization (CD-TLR)
freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.
Time frame: 12 and 24 months
CD-TLR-free survival
time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm)
Time frame: through study completion, approximately 2 years
Primary patency rate
freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm)
Time frame: 12 and 24 months
Assisted primary patency rate
freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion
Time frame: 12 and 24 months
Secondary patency rate
freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion
Time frame: 12 and 24 months
Technical success of IVL
residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention
Time frame: on the day of the procedure
Overall procedural success
residual stenosis ≤30% by the end of the complete procedure
Time frame: on the day of the procedure
Frequency and severity of procedural complications and other adverse events
Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe
Time frame: Within 30 days after the procedure
Patient-reported health-related quality-of-life
EuroQol questionnaire EQ-5D-5L
Time frame: at 6, 12 and 24 months
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia →
Cardiovascular and Interventional Radiological Society of Europe