Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
NCT ID: NCT06149650
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-07-15
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Full cohort
Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Femoropopliteal and/or crural calcified lesions visible on fluoroscopy;
* Treatment with IVl using the Shockwave Medical IVL System.
Exclusion Criteria
* Incapacity or refusal to give informed consent;
* Ongoing pregnancy;
* Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Cardiovascular and Interventional Radiological Society of Europe
OTHER
Responsible Party
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Principal Investigators
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Raman Uberoi, Dr
Role: STUDY_CHAIR
Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom
Christoph Binkert, Prof. Dr
Role: STUDY_CHAIR
Cantonal Hospital Winterthur, Winterthur, Switzerland
Peter Reimer, Prof. Dr
Role: STUDY_CHAIR
Municipal Clinic Karlsruhe, Karlsruhe, Germany
Locations
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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
Countries
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Central Contacts
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References
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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.
Other Identifiers
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CALCIO
Identifier Type: -
Identifier Source: org_study_id