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Using shockwave therapy to treat severe leg circulation problems

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Cardiovascular and Interventional Radiological Society of Europe · NCT06149650

This study is testing if shockwave therapy can help people with severe leg circulation problems heal wounds and avoid amputations.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorCardiovascular and Interventional Radiological Society of Europe (other)
Locations39 sites (Eisenstadt and 38 other locations)
Trial IDNCT06149650 on ClinicalTrials.gov

What this trial studies

CALCIO is a multicenter, prospective observational cohort study aimed at collecting real-world data on the effectiveness of intravascular lithotripsy (IVL) using the Shockwave IVL system. This study focuses on patients with chronic limb-threatening ischemia (CLTI) and aims to assess how well IVL can promote wound healing and prevent amputations. Additionally, it will evaluate the immediate effectiveness of the treatment in restoring blood flow, as well as its safety and impact on patients' quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with chronic limb-threatening ischemia and visible calcified lesions in the femoropopliteal or crural regions.

Not a fit: Patients under 18 years old, those unable to provide informed consent, or those with recent endovascular procedures at the treatment site may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing outcomes and reduce the need for amputations in patients with severe limb ischemia.

How similar studies have performed: Other studies using similar intravascular lithotripsy techniques have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* \< 18 years old;
* Incapacity or refusal to give informed consent;
* Ongoing pregnancy;
* Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.

Where this trial is running

Eisenstadt and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Limb-Threatening Ischemia, CLTI

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.