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

LimFlow, Inc.192 enrolled

Overview

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: 1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR 2. have inadequate popliteal, tibial, or pedal revascularization target

Study Type

OBSERVATIONAL

Enrollment

192

Conditions

Critical Limb Ischemia Peripheral Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject must be ≥18 years of age 2. 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 3. Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups. Exclusion Criteria: 1. 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. 2. Subject is participating in the PROMISE II Clinical Trial.

Locations (25)

LA Foot & Ankle Clinic - St. Vincent's Hospital

Outcomes

Primary Outcomes

Amputation Free Survival (AFS)

Defined as freedom from major (above ankle) amputation and death

Time frame: 12 months

Secondary Outcomes

Minor Amputation

Number of patients with below-ankle amputation of the index limb

Time frame: 12 months

Change in Rutherford Classification

Defined as a change of one class or greater, as evaluated at 6 and 12 months

Time frame: 6 months and 12 months

Data from ClinicalTrials.gov

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