Lithotripsy Clinical Trials

Clinical trials related to Lithotripsy Procedure

Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Austria
Krankenhaus der Barmherzigen Brüder
RECRUITING
Eisenstadt
Medizinische Universität Graz
RECRUITING
Graz
Krankenhaus Barmherzige Brüder Linz
RECRUITING
Linz
Klinik Florisdorf
RECRUITING
Vienna
Klinik Hietzing
RECRUITING
Vienna
Canada
Hôpital Sacré Coeur de Montréal
RECRUITING
Montreal
France
CHU François Mitterrand
RECRUITING
Dijon
Institute Mutualiste Montsouris
RECRUITING
Paris
Rhéna Clinique de Strasbourg
RECRUITING
Strasbourg
Germany
Universitätsklinikum Köln
RECRUITING
Cologne
Universitätsmedizin Essen
RECRUITING
Essen
KRH Klinikum Robert Koch Gehrden
RECRUITING
Hanover
SLK-Heilbronn
RECRUITING
Heilbronn
Städtisches Klinikum
RECRUITING
Karlsruhe
Evangelisches Krankenhaus
RECRUITING
Mülheim
Friedrich Ebert Krankenhaus
RECRUITING
Neumünster
Schön Klinik Rendsburg
RECRUITING
Rendsburg
St Marien-Krankenhaus
RECRUITING
Siegen
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Hungary
Semmelweis University
RECRUITING
Budapest
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital General de Granollers
RECRUITING
Granollers
University of Navarra
RECRUITING
Pamplona
Switzerland
Ente Ospedaliero Cantonale
RECRUITING
Lugano
Kantonsspital Winterthur
RECRUITING
Winterthur
United Kingdom
Bedfordshire Hospitals NHS Foundation Trust
RECRUITING
Bedford
Frimley Health NHS Foundation Trust
RECRUITING
Frimley
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Free London NHS Foundation Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
Sheffield Teaching Hospitals NHS FT
RECRUITING
Sheffield
Contact Information
Primary
Claire Poulet, PhD
calcio@cirse.org
+41 79 385 16 78
Backup
Dhwani S. Korde, PhD
calcio@cirse.org
+4367762942469
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 400
Treatments
Full cohort
Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
Related Therapeutic Areas
Lithotripsy
Sponsors
Leads: Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Shockwave Medical, Inc.

This content was sourced from clinicaltrials.gov

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