Critical Limb IschemiaNCT04304105
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
An observational study of Critical Limb Ischemia and Peripheral Artery Disease, run by LimFlow, Inc. at 25 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Artery Disease
- How many people
- 192 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 24 Feb 2020to 12 Sep 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
Anderson Heart and Vascular
Anderson, South Carolina, 29621
Seton Heart Institute
Austin, Texas, 78705
Austin Radiological Association
Austin, Texas, 78727
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
APCNC (Wake Med)
Cary, North Carolina, 27518
Coastal Vascular and Vein Center
Charleston, South Carolina, 29407
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Denver Veterans Affairs Medical Center
Denver, Colorado, 80205
Unity Point Health
Des Moines, Iowa, 50266
Ascension St. John Detroit
Detroit, Michigan, 48236
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
East Carolina University (ECU, Vidant Medical)
Greenville, North Carolina, 27834
Prisma Health
Greenville, South Carolina, 29615
Baylor College of Medicine
Houston, Texas, 77030
MedStar D.C.
Hyattsville, Maryland, 20782
St. Lukes Mid America
Kansas City, Missouri, 64111
Ochsner Medical Center
Kenner, Louisiana, 70065
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
LA Foot & Ankle Clinic - St. Vincent's Hospital
Los Angeles, California, 90057
VCU, Virginia Commonwealth University Health System
Richmond, Virginia, 23298
UT-San Antonio
San Antonio, Texas, 78229
Harbor- UCLA Medical Center
Torrance, California, 90501
Coastal Carolina Surgical
Wilmington, North Carolina, 28401
About this study
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.
Read the 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:
- 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
- have inadequate popliteal, tibial, or pedal revascularization target
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- CLI
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation Free Survival (AFS)
Defined as freedom from major (above ankle) amputation and death
Measured: 12 months
Secondary outcomes (2)
Minor Amputation
Number of patients with below-ankle amputation of the index limb
Measured: 12 months
Change in Rutherford Classification
Defined as a change of one class or greater, as evaluated at 6 and 12 months
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start24 Feb 2020
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- LimFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304105
- Sponsor's protocol ID
- LF-CA-PR-8
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2020
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Powell RJ, Mullin CM, Clair DG, Shishehbor MH, Dua A. Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia. Ann Vasc Surg. 2024 Feb;99:50-57. doi: 10.1016/j.avsg.2023.08.010. Epub 2023 Oct 18.
PubMed 37858666
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
- ClinicalTrials.gov ID
- NCT04304105
- Acronym / sponsor ID
- LF-CA-PR-8
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- CLI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- LimFlow, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
- have inadequate popliteal, tibial, or pedal revascularization target
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amputation Free Survival (AFS)
Time frame: 12 months
Defined as freedom from major (above ankle) amputation and death
2 secondary outcomes
Minor Amputation
Time frame: 12 months
Change in Rutherford Classification
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 37858666Powell RJ, Mullin CM, Clair DG, Shishehbor MH, Dua A. Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia. Ann Vasc Surg. 2024 Feb;99:50-57. doi: 10.1016/j.avsg.2023.08.010. Epub 2023 Oct 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia and Peripheral Artery Disease, run by LimFlow, Inc. at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation Free Survival (AFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.