Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study (CALCIO)

Cardiovascular and Interventional Radiological Society of Europe

Status: Enrolling

Conditions: Chronic Limb-Threatening Ischemia

Treatments: Device: Shockwave Medical IVL System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06149650

CALCIO

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Full cohort

Description:

Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care

Treatment:

Device: Shockwave Medical IVL System