Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

NCT06149650 | Recruiting

• 1 other identifier: CALCIO
• Study Type: observational
• Target: 400
• Locations: 8 countries
• Sites: 39

Brief 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

Keywords

CLTI

Outcome Measures

Primary Outcomes (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).

  12 months

Secondary Outcomes (15)

• Wound healing

  24 months

• Freedom from amputation

  24 months

• Amputation-free survival

  through study completion, approximately 2 years

• Change in Rutherford classification category

  12 and 24 months

• Change in foot ischemia

  12 and 24 months

Study Arms (1)

Full cohort

Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care

Device: Shockwave Medical IVL System

Interventions

Shockwave Medical IVL System DEVICE

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

Full cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (39)

Krankenhaus der Barmherzigen Brüder

Eisenstadt, 7000, Austria

RECRUITING

Medizinische Universität Graz

Graz, 8036, Austria

RECRUITING

Krankenhaus Barmherzige Brüder Linz

Linz, 4020, Austria

RECRUITING

Klinik Hietzing

Vienna, 1130, Austria

RECRUITING

Klinik Florisdorf

Vienna, 1210, Austria

RECRUITING

Hôpital Sacré Coeur de Montréal

Montreal, H4J 1C5, Canada

RECRUITING

CHU François Mitterrand

Dijon, 21000, France

RECRUITING

Institute Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Rhéna Clinique de Strasbourg

Strasbourg, 67000, France

RECRUITING

Universitätsklinikum Köln

Cologne, 50937, Germany

RECRUITING

Universitätsmedizin Essen

Essen, 45147, Germany

RECRUITING

KRH Klinikum Robert Koch Gehrden

Hanover, 30989, Germany

RECRUITING

SLK-Heilbronn

Heilbronn, 74078, Germany

RECRUITING

Städtisches Klinikum

Karlsruhe, 76133, Germany

RECRUITING

Evangelisches Krankenhaus

Mülheim, 45468, Germany

RECRUITING

Friedrich Ebert Krankenhaus

Neumünster, 24534, Germany

RECRUITING

Schön Klinik Rendsburg

Rendsburg, 24768, Germany

RECRUITING

St Marien-Krankenhaus

Siegen, 57072, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Semmelweis University

Budapest, 1085, Hungary

RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

RECRUITING

Hospital General de Granollers

Granollers, 08402, Spain

RECRUITING

University of Navarra

Pamplona, 31006, Spain

RECRUITING

Ente Ospedaliero Cantonale

Lugano, 6500, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8400, Switzerland

RECRUITING

Bedfordshire Hospitals NHS Foundation Trust

Bedford, MK42 9DJ, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Frimley, GU16 7UJ, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE1 4LP, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

RECRUITING

University Hospitals Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS FT

Sheffield, S10 2JF, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 28584945 BACKGROUND

• 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 Feb 17. doi: 10.1007/s00270-025-04335-w. Online ahead of print.

  PMID: 41703104 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Claire Poulet, PhD

CONTACT

+41 79 385 16 78; calcio@cirse.org

Dhwani S. Korde, PhD

CONTACT

+4367762942469; calcio@cirse.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 29, 2023
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); ES (3); CH (2); DE (10); HU (1); GB (14); CA (1); AU (5)