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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03085524




Registration number
NCT03085524
Ethics application status
Date submitted
14/03/2017
Date registered
20/03/2017
Date last updated
5/06/2018

Titles & IDs
Public title
The Impact of Diabetes on REvascularization
Scientific title
The Impact of Diabetes on REvascularization
Secondary ID [1] 0 0
161402
Universal Trial Number (UTN)
Trial acronym
TIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Limb Event - free survival - The combination of amputation, surgical revascularization, thrombectomy, thrombosis, interposition graft, or death
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Restenosis - Greater than 50% stenosis as determined by peak systolic velocity ratio of >2.4
Timepoint [2] 0 0
1 year

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-
Minimum age
35 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Vanderbilt University Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
New England Research Institutes
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massachusetts General Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03085524
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joshua A Beckman, MD
Address 0 0
Country 0 0
Phone 0 0
615-322-2318
Fax 0 0
Email 0 0
joshua.a.beckman@vanderbilt.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03085524