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.
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
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
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
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
France3 sites
CHU François Mitterrand
Dijon, 21000
Institute Mutualiste Montsouris
Paris, 75014
Rhéna Clinique de Strasbourg
Strasbourg, 67000
Spain3 sites
Hospital General Universitario Dr. Balmis
Alicante, 03010
Hospital General de Granollers
Granollers, 08402
University of Navarra
Pamplona, 31006
Switzerland2 sites
Ente Ospedaliero Cantonale
Lugano, 6500
Kantonsspital Winterthur
Winterthur, 8400
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.
- Conditions
- Chronic Limb-Threatening Ischemia
- 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 group | Role | What they receive |
|---|---|---|
| Full cohort | Intravascular 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.
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)
Wound healing
Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)
Measured: 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).
Measured: 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)
Measured: through study completion, approximately 2 years
Change in Rutherford classification category
Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)
Measured: 12 and 24 months
Change in foot ischemia
Change in ankle-brachial index or toe pressure, depending on which data is available
Measured: 12 and 24 months
Change in WIfi score
Three-digit score for comprehensive assessment of wound, ischemia and foot infection
Measured: 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.
Measured: 12 and 24 months
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
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
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
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
Technical success of IVL
residual diameter stenosis ≤30% after IVL and before any potential adjunctive intervention
Measured: on the day of the procedure
Overall procedural success
residual stenosis ≤30% by the end of the complete procedure
Measured: 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
Measured: Within 30 days after the procedure
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.
- First posted29 Nov 2023
- Study start15 Jul 2024
- Primary completion15 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Raman Uberoi, Dr, Study chair, Oxford University Hospital NHS Foundation Trust, Oxford, United KingdomChristoph Binkert, Prof. Dr, Study chair, Cantonal Hospital Winterthur, Winterthur, SwitzerlandPeter Reimer, Prof. Dr, Study chair, Municipal Clinic Karlsruhe, Karlsruhe, Germany
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 28584945Uberoi 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