CompletedNot Applicable

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

United States192 participantsStarted 2020-02-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Amputation Free Survival (AFS)

Timeframe: 12 months

Trial details

NCT IDNCT04304105

SponsorLimFlow, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-12

View on ClinicalTrials.gov More Critical Limb Ischemia trials