The Impact of Diabetes on REvascularization
TIDE
1 other identifier
observational
215
3 countries
43
Brief Summary
The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascularization has determined the effect of diabetes on mechanism of revascularization failure. Therefore, this trial represents a unique opportunity to investigate the mechanisms by which diabetes affects surgical and endovascular revascularization procedures with the long-term goal of improving outcomes in CLI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Longer than P75 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJuly 8, 2024
July 1, 2024
4.2 years
March 14, 2017
July 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Major Adverse Limb Event - free survival
The combination of amputation, surgical revascularization, thrombectomy, thrombosis, interposition graft, or death
1 year
Restenosis
Greater than 50% stenosis as determined by peak systolic velocity ratio of \>2.4
1 year
Study Arms (2)
Surgical Bypass
Subjects in the BEST-CLI trial assigned to surgical revascularization.
Endovascular
Subjects in the BEST-CLI trial assigned to endovascular revascularization.
Interventions
The investigators will test platelet reactivity at the beginning and midpoint of the first year after revascularization
The investigators will test bypass graft and stent patency at 30 days, 6 months, and 1 year.
Eligibility Criteria
This ancillary study is an observational study design examining the effects of diabetes mellitus on restenosis following surgical or endovascular revascularization in CLI patients. Eligible patients will be screened according to the specified exclusion and inclusion criteria of the BEST-CLI trial.
You may qualify if:
- Male or female, age 35 years or older
- Atherosclerotic, infrainguinal PAD
- CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain, consistent with Rutherford classes 4-6
- Candidate for either open or endovascular infrainguinal revascularization as judged by the treating investigators
- Adequate inflow into the index femoral artery
- Adequate popliteal, tibial, or pedal revascularization target
- Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
- Endovascular revascularization with a stent
- Surgical revascularization with a vein graft-
You may not qualify if:
- Femoropopliteal disease pattern consistent with TASC IIA
- Complete occlusion of the iliac artery
- Aortoiliac occlusive disease or severe common femoral artery disease
- Presence of a femoral, popliteal or tibial aneurysm of the index limb
- Life expectancy less than 2 years
- Deemed excessive risk for surgical bypass
- A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure
- Renal dysfunction defined as MDRD eGFR ≤ 30ml/min/173 m2 at the time of screening
- Currently on dialysis or history of a renal transplant
- A documented hypercoagulable state
- Nonatherosclerotic occlusive disease
- Any prior infrainguinal revascularization
- Current immuno-suppressive medication, chemotherapy or radiation therapy
- Absolute contraindication to iodinated contrast
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- Carelon Researchcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (43)
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
University of Florida
Gainesville, Florida, 32610, United States
Loyola University Medical Center
Chicago, Illinois, 60153, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
University Health System: LSU Health Sciences
Shreveport, Louisiana, 71103, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Michigan Vascular Center
Flint, Michigan, 48507, United States
Michigan Heart - St. Joseph Mercy Health System
Ypsilanti, Michigan, 48197, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
Rutgers University Hospital
Newark, New Jersey, 07103, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
Albany Medical Center
Albany, New York, 12208, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 28157, United States
The Ohio State University
Columbus, Ohio, 43210, United States
University of Toledo Medical Center
Toledo, Ohio, 43604, United States
Oregon Health and Science University
Portland, Oregon, 97204, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98122, United States
Gunderson Health System
La Crosse, Wisconsin, 54601, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53706, United States
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook Health Sciences
Toronto, Ontario, M4N 3M5, Canada
Chu de Quebec, St-Francois d'Assise Hospital
Québec, Quebec, G1L 3P7, Canada
Helsinki University Hospital
Helsinki, 00029, Finland
Related Publications (1)
Sullivan AE, Huang S, Kundu S, Thomas VE, Clair DG, Aday AW, Menard MT, Farber A, Rosenfield K, Newman JD, Berger JS, Wells QS, Freiberg MS, Linton MF, Beckman JA. Association of Lipoprotein(a) With Major Adverse Limb Events and All-Cause Mortality Following Revascularization for Chronic Limb-Threatening Ischemia: A Substudy of the BEST-CLI Trial. J Am Heart Assoc. 2025 Jun 3;14(11):e041177. doi: 10.1161/JAHA.125.041177. Epub 2025 May 22.
PMID: 40401600DERIVED
Biospecimen
Leukocytes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 14, 2017
First Posted
March 21, 2017
Study Start
August 1, 2017
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
July 8, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
The proposed research will include data from approximately 500 subjects enrolled in the BEST-CLI clinical trial. The final dataset will include self-reported demographic, ultrasonographic, and laboratory data from the subjects. The investigators will be collecting identifying information, but the final dataset will be stripped of identifiers prior to release for sharing. Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.