Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.

The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:

• 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
• have inadequate popliteal, tibial, or pedal revascularization target

Inclusion criteria

• Subject must be ≥18 years of age
• Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target
• Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups.

Exclusion criteria

• Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
• Subject is participating in the PROMISE II Clinical Trial.