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

November 18, 2024 updated by: LimFlow, Inc.
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • San Lucas Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • LA Foot & Ankle Clinic - St. Vincent's Hospital
      • Torrance, California, United States, 90501
        • Harbor- UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80205
        • Denver Veterans Affairs Medical Center
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Cardiac and Vascular Institute
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Unity Point Health
    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • Ochsner Medical Center
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar D.C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Detroit
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Lukes Mid America
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • APCNC (Wake Med)
      • Greenville, North Carolina, United States, 27834
        • East Carolina University (ECU, Vidant Medical)
      • Wilmington, North Carolina, United States, 28401
        • Coastal Carolina Surgical
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Anderson Heart and Vascular
      • Charleston, South Carolina, United States, 29407
        • Coastal Vascular and Vein Center
      • Greenville, South Carolina, United States, 29615
        • Prisma Health
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Heart Institute
      • Austin, Texas, United States, 78727
        • Austin Radiological Association
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • UT-San Antonio
    • Virginia
      • Richmond, Virginia, United States, 23298
        • VCU, Virginia Commonwealth University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LimFlow, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Actual)

September 12, 2022

Study Completion (Actual)

September 12, 2022

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF-CA-PR-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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