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

Completed

Conditions studied: Critical Limb Ischemia, Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT04304105

Run by

LimFlow, Inc.

People needed

192

Starts

2020-02-24

Expected to finish

2022-09-12

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• The Cardiac and Vascular Institute — Gainesville, Florida, 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
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• APCNC (Wake Med) — Cary, North Carolina, United States
• East Carolina University (ECU, Vidant Medical) — Greenville, North Carolina, United States
• Coastal Carolina Surgical — Wilmington, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Anderson Heart and Vascular — Anderson, South Carolina, United States
• Coastal Vascular and Vein Center — Charleston, South Carolina, United States
• Prisma Health — Greenville, South Carolina, United States
• Seton Heart Institute — Austin, Texas, United States
• Austin Radiological Association — Austin, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• UT-San Antonio — San Antonio, Texas, United States
• VCU, Virginia Commonwealth University Health System — Richmond, Virginia, United States
• San Lucas Hospital — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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