Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03085524
Ethics application status
Date submitted
14/03/2017
Date registered
21/03/2017
Date last updated
8/07/2024

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Surgical Bypass - Subjects in the BEST-CLI trial assigned to surgical revascularization.
Comparator / control treatment
Control group

Outcomes

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
Accrual to date
Final
215
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Vanderbilt University Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03085524