Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System.
D K Filippiadis, C Binkert, O Pellerin...
https://pubmed.ncbi.nlm.nih.gov/28584945Actively Recruiting
Age: 18Years +
All Genders
ID06149650
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
Led by Cardiovascular and Interventional Radiological Society of Europe · Updated on 2026-05-13
400
Participants Needed
39
Research Sites
24 weeks
Total Duration
On this page
Sponsors
C
Cardiovascular and Interventional Radiological Society of Europe
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting real-world data on the use of intravascular lithotripsy (IVL) with the Shockwave IVL system to treat calcified femoropopliteal and crural lesions in patients who have chronic limb-threatening ischemia (CLTI). The study aims to understand how well IVL helps with wound healing and prevents amputation. It will also evaluate the immediate success of the treatment in opening blood vessels, as well as its safety and impact on patients' quality of life. During the study, patients will receive IVL treatment using the Shockwave Medical IVL System, which includes a generator, connector cable, and a single-use catheter with an integrated balloon designed to break up artery calcification. Treatment is given according to standard care for the affected arteries in the leg. This is an observational study, so the treatment follows usual medical practice without additional experimental interventions. Participants will be monitored for up to 24 months to assess wound healing, amputation rates, survival without amputation, and changes in blood flow and limb condition using several clinical classifications and scores. Researchers will track vessel openness, technical success of the procedure, complications within 30 days, and patient-reported quality of life at several time points. The study helps gather important information on the real-world use and benefits of IVL in this patient group.
CONDITIONS
Brief Title
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient with chronic limb-threatening ischemia (Rutherford Category �34)
- Femoropopliteal and/or crural calcified lesions visible on fluoroscopy
- Treatment with IVL using the Shockwave Medical IVL System
You will not qualify if you...
- Younger than 18 years old
- Unable or unwilling to give informed consent
- Currently pregnant
- Endovascular procedure on the treatment site within 4 weeks before planned IVL treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of the procedure
Participants undergo intravascular lithotripsy treatment of femoropopliteal and crural lesions using the Shockwave Medical IVL System as per standard of care.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 24 months
Participants are monitored for wound healing, freedom from amputation, and other health outcomes up to approximately 2 years after treatment.
Visits at 6, 12, and 24 months with additional assessments through study completion
Trial Site Locations
Total: 39 locations
1
Krankenhaus der Barmherzigen Brüder
Eisenstadt, Austria, 7000
Actively Recruiting
2
Medizinische Universität Graz
Graz, Austria, 8036
Actively Recruiting
3
Krankenhaus Barmherzige Brüder Linz
Linz, Austria, 4020
Actively Recruiting
4
Klinik Hietzing
Vienna, Austria, 1130
Actively Recruiting
5
Klinik Florisdorf
Vienna, Austria, 1210
Actively Recruiting
6
Hôpital Sacré Coeur de Montréal
Montreal, Canada, H4J 1C5
Actively Recruiting
7
CHU François Mitterrand
Dijon, France, 21000
Actively Recruiting
8
Institute Mutualiste Montsouris
Paris, France, 75014
Actively Recruiting
9
Rhéna Clinique de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
10
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
11
Universitätsmedizin Essen
Essen, Germany, 45147
Actively Recruiting
12
KRH Klinikum Robert Koch Gehrden
Hanover, Germany, 30989
Actively Recruiting
13
SLK-Heilbronn
Heilbronn, Germany, 74078
Actively Recruiting
14
Städtisches Klinikum
Karlsruhe, Germany, 76133
Actively Recruiting
15
Evangelisches Krankenhaus
Mülheim, Germany, 45468
Actively Recruiting
16
Friedrich Ebert Krankenhaus
Neumünster, Germany, 24534
Actively Recruiting
17
Schön Klinik Rendsburg
Rendsburg, Germany, 24768
Actively Recruiting
18
St Marien-Krankenhaus
Siegen, Germany, 57072
Actively Recruiting
19
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
20
Semmelweis University
Budapest, Hungary, 1085
Actively Recruiting
21
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
22
Hospital General de Granollers
Granollers, Spain, 08402
Actively Recruiting
23
University of Navarra
Pamplona, Spain, 31006
Actively Recruiting
24
Ente Ospedaliero Cantonale
Lugano, Switzerland, 6500
Actively Recruiting
25
Kantonsspital Winterthur
Winterthur, Switzerland, 8400
Actively Recruiting
26
Bedfordshire Hospitals NHS Foundation Trust
Bedford, United Kingdom, MK42 9DJ
Actively Recruiting
27
Frimley Health NHS Foundation Trust
Frimley, United Kingdom, GU16 7UJ
Actively Recruiting
28
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
29
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
30
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L7 8XP
Actively Recruiting
31
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
32
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Actively Recruiting
33
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
34
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Actively Recruiting
35
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
36
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
37
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
38
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
39
Sheffield Teaching Hospitals NHS FT
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
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Research Team
C
Claire Poulet, PhD
D
Dhwani S. Korde, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Intravascular Lithotripsy for Patients with Chronic Limb-Threatening Ischemia: Study Protocol for CALCIO, a Prospective Multicenter Observational Investigation.
Raman Uberoi, Peter Reimer, Joo-Young Chun...
https://pubmed.ncbi.nlm.nih.gov/41703104