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.
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.
< 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.
CLTI patients with calcified femoropopliteal or crural lesions visible on fluoroscopy and treated with Intravascular Lithotripsy.
Cohort
Prospective
Shockwave Medical IVL System
DeviceComprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.
Wound healing and freedom from amputation
Composite of wound healing defined as the healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) and freedom from amputation defined as the absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).
Wound healing
Healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening)
Freedom from amputation
Absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).
Amputation-free survival
time between IVL treatment and amputation of the target limb, minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure)
Change in Rutherford classification category
Seven classification categories, from 0 (asymptomatic) to 6 (Major tissue loss)
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Cardiovascular and Interventional Radiological Society of Europe
Lead sponsor
Shockwave Medical, Inc.
Collaborator
