RecruitingNCT06149650

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Enrollment

400 participants

Start Date

Jul 15, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Limb Threatening Ischemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Shockwave Medical IVL System for people with chronic limb threatening ischemia. The study is currently recruiting participants at 39 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEShockwave 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.

Locations(39)

Krankenhaus der Barmherzigen Brüder

Eisenstadt, Austria

Medizinische Universität Graz

Graz, Austria

Krankenhaus Barmherzige Brüder Linz

Linz, Austria

Klinik Hietzing

Vienna, Austria

Klinik Florisdorf

Vienna, Austria

Hôpital Sacré Coeur de Montréal

Montreal, Canada

CHU François Mitterrand

Dijon, France

Institute Mutualiste Montsouris

Paris, France

Rhéna Clinique de Strasbourg

Strasbourg, France

Universitätsklinikum Köln

Cologne, Germany

Universitätsmedizin Essen

Essen, Germany

KRH Klinikum Robert Koch Gehrden

Hanover, Germany

SLK-Heilbronn

Heilbronn, Germany

Städtisches Klinikum

Karlsruhe, Germany

Evangelisches Krankenhaus

Mülheim, Germany

Friedrich Ebert Krankenhaus

Neumünster, Germany

Schön Klinik Rendsburg

Rendsburg, Germany

St Marien-Krankenhaus

Siegen, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Semmelweis University

Budapest, Hungary

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital General de Granollers

Granollers, Spain

University of Navarra

Pamplona, Spain

Ente Ospedaliero Cantonale

Lugano, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Bedfordshire Hospitals NHS Foundation Trust

Bedford, United Kingdom

Frimley Health NHS Foundation Trust

Frimley, United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Sheffield Teaching Hospitals NHS FT

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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