Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
1 other identifier
observational
192
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2020
CompletedFirst Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2022
CompletedNovember 20, 2024
November 1, 2024
2.6 years
March 9, 2020
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amputation Free Survival (AFS)
Defined as freedom from major (above ankle) amputation and death
12 months
Secondary Outcomes (2)
Minor Amputation
12 months
Change in Rutherford Classification
6 months and 12 months
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LimFlow, Inc.lead
Study Sites (25)
LA Foot & Ankle Clinic - St. Vincent's Hospital
Los Angeles, California, 90057, United States
Harbor- UCLA Medical Center
Torrance, California, 90501, United States
Denver Veterans Affairs Medical Center
Denver, Colorado, 80205, United States
The Cardiac and Vascular Institute
Gainesville, Florida, 32605, United States
Unity Point Health
Des Moines, Iowa, 50266, United States
Ochsner Medical Center
Kenner, Louisiana, 70065, United States
MedStar D.C.
Hyattsville, Maryland, 20782, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Ascension St. John Detroit
Detroit, Michigan, 48236, United States
St. Lukes Mid America
Kansas City, Missouri, 64111, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
APCNC (Wake Med)
Cary, North Carolina, 27518, United States
East Carolina University (ECU, Vidant Medical)
Greenville, North Carolina, 27834, United States
Coastal Carolina Surgical
Wilmington, North Carolina, 28401, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Anderson Heart and Vascular
Anderson, South Carolina, 29621, United States
Coastal Vascular and Vein Center
Charleston, South Carolina, 29407, United States
Prisma Health
Greenville, South Carolina, 29615, United States
Seton Heart Institute
Austin, Texas, 78705, United States
Austin Radiological Association
Austin, Texas, 78727, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
UT-San Antonio
San Antonio, Texas, 78229, United States
VCU, Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
San Lucas Hospital
Ponce, 00716, Puerto Rico
Related Publications (1)
Powell RJ, Mullin CM, Clair DG, Shishehbor MH, Dua A. Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia. Ann Vasc Surg. 2024 Feb;99:50-57. doi: 10.1016/j.avsg.2023.08.010. Epub 2023 Oct 18.
PMID: 37858666BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 11, 2020
Study Start
February 24, 2020
Primary Completion
September 12, 2022
Study Completion
September 12, 2022
Last Updated
November 20, 2024
Record last verified: 2024-11