Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Shockwave Medical IVL System: Comprehensive system consisting of generator, a connector cable and a single-use sterile catheter with integrated balloon for intravascular lithotripsy of peripheral artery calcification.

Study 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

Primary outcome measure(s)

• Wound healing and freedom from amputation — 12 months
  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).

Trial sites (39)

More Cardiovascular and Interventional Radiological Society of Europe trials in Spain