NCT03085524

The Impact of Diabetes on REvascularization

Official Title:

The Impact of Diabetes on REvascularization

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.

Eligibility

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-

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

Disease(s) and\or Condition(s)

Peripheral Arterial Disease

Diabetes Mellitus

Primary Purpose
Intervention/Treatment
    • Type: DIAGNOSTIC_TEST
    • Name: Platelet function testing
    • Description: The investigators will test platelet reactivity at the beginning and midpoint of the first year after revascularization
    • Arm Group Labels: Endovascular, Surgical Bypass
    • Type: DIAGNOSTIC_TEST
    • Name: Vascular ultrasonography
    • Description: The investigators will test bypass graft and stent patency at 30 days, 6 months, and 1 year.
    • Arm Group Labels: Endovascular, Surgical Bypass
Sponsor
  • Vanderbilt University Medical Center