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Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Active Not RecruitingN/A

Sponsor: Cardiovascular and Interventional Radiological Society of Europe

Conditions: Chronic Limb-Threatening Ischemia

Interventions: Shockwave Medical IVL System

Countries: Austria, Canada, France, Germany, Hungary, Spain, Switzerland, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* \< 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.

Locations (39)

Eisenstadt, Austria
Graz, Austria
Linz, Austria
Vienna, Austria
Vienna, Austria
Montreal, Canada
Dijon, France
Paris, France
Strasbourg, France
Cologne, Germany
Essen, Germany
Hanover, Germany
Heilbronn, Germany
Karlsruhe, Germany
Mülheim, Germany
Neumünster, Germany
Rendsburg, Germany
Siegen, Germany
Tübingen, Germany
Budapest, Hungary
Alicante, Spain
Granollers, Spain
Pamplona, Spain
Lugano, Switzerland
Winterthur, Switzerland
Bedford, United Kingdom
Frimley, United Kingdom
Hull, United Kingdom
Leeds, United Kingdom
Liverpool, United Kingdom
+ 9 more on CT.gov