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Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

NCT06149650 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Chronic Limb-Threatening Ischemia

Interventions

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.

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • Cardiovascular and Interventional Radiological Society of Europe

    lead OTHER

Principal Investigators

  • Raman Uberoi, Dr · Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom

  • Christoph Binkert, Prof. Dr · Cantonal Hospital Winterthur, Winterthur, Switzerland

  • Peter Reimer, Prof. Dr · Municipal Clinic Karlsruhe, Karlsruhe, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2028-07-15
Completion
2028-12-31

Countries

  • Austria
  • Canada
  • France
  • Germany
  • Hungary
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149650 on ClinicalTrials.gov