Clinical trial NCT04304105: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Official title: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Peripheral Artery Disease
Keywords: CLI
Lead sponsor: LimFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Amputation Free Survival (AFS)
timeFrame: 12 months
Secondary outcomes:
measure: Minor Amputation
timeFrame: 12 months
measure: Change in Rutherford Classification
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA Foot & Ankle Clinic - St. Vincent's Hospital
state: California
city: Torrance
country: United States
facility: Harbor- UCLA Medical Center
state: California
city: Denver
country: United States
facility: Denver Veterans Affairs Medical Center
state: Colorado
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Des Moines
country: United States
facility: Unity Point Health
state: Iowa
city: Kenner
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Hyattsville
country: United States
facility: MedStar D.C.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Ascension St. John Detroit
state: Michigan
city: Kansas City
country: United States
facility: St. Lukes Mid America
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Cary
country: United States
facility: APCNC (Wake Med)
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University (ECU, Vidant Medical)
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Carolina Surgical
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Anderson
country: United States
facility: Anderson Heart and Vascular
state: South Carolina
city: Charleston
country: United States
facility: Coastal Vascular and Vein Center
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Austin
country: United States
facility: Seton Heart Institute
state: Texas
city: Austin
country: United States
facility: Austin Radiological Association
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: UT-San Antonio
state: Texas
city: Richmond
country: United States
facility: VCU, Virginia Commonwealth University Health System
state: Virginia
city: Ponce
country: Puerto Rico
facility: San Lucas Hospital
Study officials:
References:
citation: 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.