An observational study in Critical Limb Ischemia and Peripheral Artery Disease, sponsored by LimFlow, Inc.. Completed at 25 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by LimFlow, Inc. · Observational
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 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:
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 192 is close to the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →LimFlow, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Amputation Free Survival (AFS)
Defined as freedom from major (above ankle) amputation and death
Time frame: 12 months
Minor Amputation
Number of patients with below-ankle amputation of the index limb
Time frame: 12 months
Change in Rutherford Classification
Defined as a change of one class or greater, as evaluated at 6 and 12 months
Time frame: 6 months and 12 months
Plan to share: Undecided
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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LimFlow, Inc.