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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304105
Recruitment Status : Active, not recruiting
First Posted : March 11, 2020
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
LimFlow, Inc.

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 one-year period.

Condition or disease
Critical Limb Ischemia Peripheral Artery Disease

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Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Amputation Free Survival (AFS) [ Time Frame: 12 months ]
    Defined as freedom from major (above ankle) amputation and death


Secondary Outcome Measures :
  1. Minor Amputation [ Time Frame: 12 months ]
    Number of patients with below-ankle amputation of the index limb



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304105


Locations
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United States, Florida
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
LimFlow, Inc.
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Responsible Party: LimFlow, Inc.
ClinicalTrials.gov Identifier: NCT04304105    
Other Study ID Numbers: LF-CA-PR-8
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LimFlow, Inc.:
CLI
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases