Status:
RECRUITING
Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
Lead Sponsor:
Cardiovascular and Interventional Radiological Society of Europe
Collaborating Sponsors:
Shockwave Medical, Inc.
Conditions:
Chronic Limb-Threatening Ischemia
Eligibility:
All Genders
18+ years
Brief 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 femo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \< 18 years old;
- Incapacity or refusal to give informed consent;
- Ongoing pregnancy;
- Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06149650
Start Date
July 15 2024
End Date
December 31 2028
Last Update
December 30 2025
Active Locations (39)
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1
Krankenhaus der Barmherzigen Brüder
Eisenstadt, Austria, 7000
2
Medizinische Universität Graz
Graz, Austria, 8036
3
Krankenhaus Barmherzige Brüder Linz
Linz, Austria, 4020
4
Klinik Hietzing
Vienna, Austria, 1130