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Chronic Limb-Threatening IschemiaCALCIONCT06149650

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

An observational study of Chronic Limb-Threatening Ischemia, run by Cardiovascular and Interventional Radiological Society of Europe at 39 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Limb-Threatening Ischemia
What is being tested?
Shockwave Medical IVL System
Type of treatment
Medical device
How many people
400 participants
Where
39 sitesin 8 countries
Study dates
15 Jul 2024to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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 join

  • < 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.

Trial locations and contacts

39 sites in 8 countries.

39 sites in 8 countries

United Kingdom14 sites

  • Bedfordshire Hospitals NHS Foundation Trust

    Bedford, MK42 9DJ

  • Frimley Health NHS Foundation Trust

    Frimley, GU16 7UJ

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE1 4LP

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

  • Sheffield Teaching Hospitals NHS FT

    Sheffield, S10 2JF

Other trials in United Kingdom

Germany10 sites

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsmedizin Essen

    Essen, 45147

  • KRH Klinikum Robert Koch Gehrden

    Hanover, 30989

  • SLK-Heilbronn

    Heilbronn, 74078

  • Städtisches Klinikum

    Karlsruhe, 76133

  • Evangelisches Krankenhaus

    Mülheim, 45468

  • Friedrich Ebert Krankenhaus

    Neumünster, 24534

  • Schön Klinik Rendsburg

    Rendsburg, 24768

  • St Marien-Krankenhaus

    Siegen, 57072

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Austria5 sites

  • Krankenhaus der Barmherzigen Brüder

    Eisenstadt, 7000

  • Medizinische Universität Graz

    Graz, 8036

  • Krankenhaus Barmherzige Brüder Linz

    Linz, 4020

  • Klinik Hietzing

    Vienna, 1130

  • Klinik Florisdorf

    Vienna, 1210

Other trials in Austria

France3 sites

  • CHU François Mitterrand

    Dijon, 21000

  • Institute Mutualiste Montsouris

    Paris, 75014

  • Rhéna Clinique de Strasbourg

    Strasbourg, 67000

Other trials in France

Spain3 sites

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

  • Hospital General de Granollers

    Granollers, 08402

  • University of Navarra

    Pamplona, 31006

Other trials in Spain

Switzerland2 sites

  • Ente Ospedaliero Cantonale

    Lugano, 6500

  • Kantonsspital Winterthur

    Winterthur, 8400

Other trials in Switzerland

Canada1 site

  • Hôpital Sacré Coeur de Montréal

    Montreal, H4J 1C5

Other trials in Canada

Hungary1 site

  • Semmelweis University

    Budapest, 1085

Other trials in Hungary

About this study

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.

Being tested
Shockwave Medical IVL System
Keywords
CLTI
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shockwave Medical IVL SystemDevice

    Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.

Study groups in NCT06149650
Study groupRoleWhat they receive
Full cohortIntravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
Receives: Device: Shockwave Medical IVL System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

Secondary outcomes (15)

  1. Wound healing

    Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)

    Measured: 24 months

  2. 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).

    Measured: 24 months

  3. 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)

    Measured: through study completion, approximately 2 years

  4. Change in Rutherford classification category

    Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)

    Measured: 12 and 24 months

  5. Change in foot ischemia

    Change in ankle-brachial index or toe pressure, depending on which data is available

    Measured: 12 and 24 months

  6. Change in WIfi score

    Three-digit score for comprehensive assessment of wound, ischemia and foot infection

    Measured: 12 and 24 months

  7. 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.

    Measured: 12 and 24 months

  8. CD-TLR-free survival

    time between IVL treatment and any endovascular re-intervention to the target lesion (± 10 mm)

    Measured: through study completion, approximately 2 years

  9. Primary patency rate

    freedom from total occlusion without any endovascular or surgical re-intervention to the target lesion (± 10 mm)

    Measured: 12 and 24 months

  10. Assisted primary patency rate

    freedom from total occlusion following additional endovascular or surgical intervention(s) due to restenosis of the target lesion

    Measured: 12 and 24 months

  11. Secondary patency rate

    freedom from total occlusion following additional endovascular or surgical intervention(s) due to occlusion of the target lesion

    Measured: 12 and 24 months

  12. Technical success of IVL

    residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention

    Measured: on the day of the procedure

  13. Overall procedural success

    residual stenosis ≤30% by the end of the complete procedure

    Measured: on the day of the procedure

  14. 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

    Measured: Within 30 days after the procedure

  15. Patient-reported health-related quality-of-life

    EuroQol questionnaire EQ-5D-5L

    Measured: at 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start15 Jul 2024
  3. Primary completion15 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06149650
Sponsor's protocol ID
CALCIO
Acronym
CALCIO
Status last verified
Jul 2026
First submitted
15 Nov 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5.

    PubMed 28584945

  • Uberoi R, Reimer P, Chun JY, Goyault G, Kashef E, Loffroy R, Rand T, Ruffino MA, von Stempel C, Lange T, Zeka B, Poulet C, Kaufmann N, Binkert C. Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a Prospective Multicenter Observational Investigation. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1219-1226. doi: 10.1007/s00270-025-04335-w. Epub 2026 Feb 17.

    PubMed 41703104

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Limb-Threatening Ischemia, run by Cardiovascular and Interventional Radiological Society of Europe at 39 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United Kingdom, Germany, Austria, France, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound healing and freedom from amputation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06149650, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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