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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03085524
Registration number
NCT03085524
Ethics application status
Date submitted
14/03/2017
Date registered
21/03/2017
Date last updated
29/08/2023
Titles & IDs
Public title
The Impact of Diabetes on REvascularization
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Scientific title
The Impact of Diabetes on REvascularization
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Secondary ID [1]
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161402
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Universal Trial Number (UTN)
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Trial acronym
TIDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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Diabetes Mellitus
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Platelet function testing
Diagnosis / Prognosis - Vascular ultrasonography
Surgical Bypass - Subjects in the BEST-CLI trial assigned to surgical revascularization.
Endovascular - Subjects in the BEST-CLI trial assigned to endovascular revascularization.
Diagnosis / Prognosis: Platelet function testing
The investigators will test platelet reactivity at the beginning and midpoint of the first year after revascularization
Diagnosis / Prognosis: Vascular ultrasonography
The investigators will test bypass graft and stent patency at 30 days, 6 months, and 1 year.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Adverse Limb Event - free survival
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Assessment method [1]
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The combination of amputation, surgical revascularization, thrombectomy, thrombosis, interposition graft, or death
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Timepoint [1]
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1 year
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Primary outcome [2]
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Restenosis
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Assessment method [2]
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Greater than 50% stenosis as determined by peak systolic velocity ratio of >2.4
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Timepoint [2]
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1 year
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Eligibility
Key inclusion criteria
- 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-
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Minimum age
35
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2024
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Connecticut
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North Carolina
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Ontario
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Finland
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Helsinki
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Funding & Sponsors
Primary sponsor type
Other
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Name
Vanderbilt University Medical Center
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Carelon Research
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Other
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Massachusetts General Hospital
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03085524
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03085524
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