Trials / Completed
CompletedNCT04304105
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 192 (actual)
- Sponsor
- LimFlow, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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
Conditions
Timeline
- Start date
- 2020-02-24
- Primary completion
- 2022-09-12
- Completion
- 2022-09-12
- First posted
- 2020-03-11
- Last updated
- 2024-11-20
Locations
25 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT04304105. Inclusion in this directory is not an endorsement.