Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
- Conditions
- Critical Limb IschemiaPeripheral 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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.
- 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.
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
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
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States