Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study (CALCIO)

July 29, 2026 updated by: Cardiovascular and Interventional Radiological Society of Europe
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Eisenstadt, Austria, 7000
        • Krankenhaus der Barmherzigen Brüder
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Linz, Austria, 4020
        • Krankenhaus Barmherzige Brüder Linz
      • Vienna, Austria, 1130
        • Klinik Hietzing
      • Vienna, Austria, 1210
        • Klinik Florisdorf
  • Canada
      • Montreal, Canada, H4J 1C5
        • Hôpital Sacré Coeur de Montréal
  • France
      • Dijon, France, 21000
        • CHU François Mitterrand
      • Paris, France, 75014
        • Institute Mutualiste Montsouris
      • Strasbourg, France, 67000
        • Rhéna Clinique de Strasbourg
  • Germany
      • Cologne, Germany, 50937
        • Universitätsklinikum Köln
      • Essen, Germany, 45147
        • Universitätsmedizin Essen
      • Hanover, Germany, 30989
        • KRH Klinikum Robert Koch Gehrden
      • Heilbronn, Germany, 74078
        • SLK-Heilbronn
      • Karlsruhe, Germany, 76133
        • Städtisches Klinikum
      • Mülheim, Germany, 45468
        • Evangelisches Krankenhaus
      • Neumünster, Germany, 24534
        • Friedrich Ebert Krankenhaus
      • Rendsburg, Germany, 24768
        • Schön Klinik Rendsburg
      • Siegen, Germany, 57072
        • St Marien-Krankenhaus
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario Dr. Balmis
      • Granollers, Spain, 08402
        • Hospital General de Granollers
      • Pamplona, Spain, 31006
        • University of Navarra
  • Switzerland
      • Lugano, Switzerland, 6500
        • Ente Ospedaliero Cantonale
      • Winterthur, Switzerland, 8400
        • Kantonsspital Winterthur
  • United Kingdom
      • Bedford, United Kingdom, MK42 9DJ
        • Bedfordshire Hospitals NHS Foundation Trust
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Health NHS Foundation Trust
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
      • Leeds, United Kingdom, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals Nhs Foundation Trust
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust
      • Newcastle, United Kingdom, NE1 4LP
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
      • Plymouth, United Kingdom, PL6 8DH
        • University Hospitals Plymouth NHS Trust
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS FT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Full cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing and freedom from amputation
Time Frame: 12 months
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 24 months
Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)
24 months
Freedom from amputation
Time Frame: 24 months
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).
24 months
Amputation-free survival
Time Frame: through study completion, approximately 2 years
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)
through study completion, approximately 2 years
Change in Rutherford classification category
Time Frame: 12 and 24 months
Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)
12 and 24 months
Change in foot ischemia
Time Frame: 12 and 24 months
Change in ankle-brachial index or toe pressure, depending on which data is available
12 and 24 months
Change in WIfi score
Time Frame: 12 and 24 months
Three-digit score for comprehensive assessment of wound, ischemia and foot infection
12 and 24 months
CD-TLR-free survival
Time Frame: through study completion, approximately 2 years
time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm)
through study completion, approximately 2 years
Primary patency rate
Time Frame: 12 and 24 months
freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm)
12 and 24 months
Assisted primary patency rate
Time Frame: 12 and 24 months
freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion
12 and 24 months
Secondary patency rate
Time Frame: 12 and 24 months
freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion
12 and 24 months
Technical success of IVL
Time Frame: on the day of the procedure
residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention
on the day of the procedure
Overall procedural success
Time Frame: on the day of the procedure
residual stenosis ≤30% by the end of the complete procedure
on the day of the procedure
Patient-reported health-related quality-of-life
Time Frame: at 6, 12 and 24 months
EuroQol questionnaire EQ-5D-5L
at 6, 12 and 24 months
Freedom from clinically-driven target lesion revascularization (CD-TLR)
Time Frame: 12 and 24 months
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.
12 and 24 months
Frequency and severity of procedural complications and other adverse events
Time Frame: Within 30 days after the procedure
Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe
Within 30 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Collaborators

Shockwave Medical, Inc.

Investigators

  • Study Chair: Raman Uberoi, Dr, Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom
  • Study Chair: Christoph Binkert, Prof. Dr, Cantonal Hospital Winterthur, Winterthur, Switzerland
  • Study Chair: Peter Reimer, Prof. Dr, Municipal Clinic Karlsruhe, Karlsruhe, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALCIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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