Status:
COMPLETED
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Lead Sponsor:
LimFlow, Inc.
Conditions:
Critical Limb Ischemia
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 12 2022
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT04304105
Start Date
February 24 2020
End Date
September 12 2022
Last Update
November 20 2024
Active Locations (25)
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1
LA Foot & Ankle Clinic - St. Vincent's Hospital
Los Angeles, California, United States, 90057
2
Harbor- UCLA Medical Center
Torrance, California, United States, 90501
3
Denver Veterans Affairs Medical Center
Denver, Colorado, United States, 80205
4
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605