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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04304105

Enrollment

192

Registered

2020-03-11

Start date

2020-02-24

Completion date

2022-09-12

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Peripheral Artery Disease

Keywords

CLI

Brief summary

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Amputation Free Survival (AFS)	12 months	Defined as freedom from major (above ankle) amputation and death

Secondary

Measure	Time frame	Description
Minor Amputation	12 months	Number of patients with below-ankle amputation of the index limb
Change in Rutherford Classification	6 months and 12 months	Defined as a change of one class or greater, as evaluated at 6 and 12 months

Countries

Puerto Rico, United States

Outcome results