Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
NCT ID: NCT04304105
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
192 participants
OBSERVATIONAL
2020-02-24
2022-09-12
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. Subject is participating in the PROMISE II Clinical Trial.
18 Years
ALL
No
Sponsors
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LimFlow, Inc.
INDUSTRY
Responsible Party
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Locations
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LA Foot & Ankle Clinic - St. Vincent's Hospital
Los Angeles, California, United States
Harbor- UCLA Medical Center
Torrance, California, United States
Denver Veterans Affairs Medical Center
Denver, Colorado, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Unity Point Health
Des Moines, Iowa, United States
Ochsner Medical Center
Kenner, Louisiana, United States
MedStar D.C.
Hyattsville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Ascension St. John Detroit
Detroit, Michigan, United States
St. Lukes Mid America
Kansas City, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
APCNC (Wake Med)
Cary, North Carolina, United States
East Carolina University (ECU, Vidant Medical)
Greenville, North Carolina, United States
Coastal Carolina Surgical
Wilmington, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Anderson Heart and Vascular
Anderson, South Carolina, United States
Coastal Vascular and Vein Center
Charleston, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Seton Heart Institute
Austin, Texas, United States
Austin Radiological Association
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
UT-San Antonio
San Antonio, Texas, United States
VCU, Virginia Commonwealth University Health System
Richmond, Virginia, United States
San Lucas Hospital
Ponce, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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LF-CA-PR-8
Identifier Type: -
Identifier Source: org_study_id
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