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Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
Sponsor: Cardiovascular and Interventional Radiological Society of Europe
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2024-07-15
Completion Date
2028-12-31
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
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.
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