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

Completed

• Conditions: Critical Limb Ischemia; Peripheral Artery Disease

• Registration Number: NCT04304105
• Lead Sponsor: LimFlow, Inc.

Brief Summary

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.

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

Study Timeline

• Study Start: 2020-02-24
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amputation Free Survival (AFS)	12 months	Defined as freedom from major (above ankle) amputation and death

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

LA Foot & Ankle Clinic - St. Vincent's Hospital; 🇺🇸 Los Angeles, California, United States

Harbor- UCLA Medical Center; 🇺🇸 Torrance, California, United States

Denver Veterans Affairs Medical Center; 🇺🇸 Denver, Colorado, United States

Unity Point Health; 🇺🇸 Des Moines, Iowa, United States

Ochsner Medical Center; 🇺🇸 Kenner, Louisiana, United States

MedStar D.C.; 🇺🇸 Hyattsville, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Ascension St. John Detroit; 🇺🇸 Detroit, Michigan, United States

St. Lukes Mid America; 🇺🇸 Kansas City, Missouri, United States

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