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NCT04304105 Clinical Trial

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

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04304105
Other study ID # LF-CA-PR-8
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 24, 2020
Est. completion date October 1, 2023

Study information
Verified date April 2022
Source LimFlow, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date October 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Cardiac and Vascular Institute Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
LimFlow, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amputation Free Survival (AFS) Defined as freedom from major (above ankle) amputation and death 12 months
Secondary Minor Amputation Number of patients with below-ankle amputation of the index limb 12 months
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