TRanslesIonal Assessment of Gradients During Endovascular Therapy

Study Overview
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Brief Summary
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Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease. Secondary objectives: Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs

Detailed Description
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There are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. The present study will use the NAVVUS RXi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.

Official Title
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TRanslesIonal Assessment of Gradients During Endovascular Therapy

Conditions
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Peripheral Arterial Disease, Fractional Flow Reserve, Hemodynamics

Intervention / Treatment
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* Device: Translesional Hemodynamic Measurement


Participation Criteria
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Eligibility Criteria
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Inclusions: Age >18 y/o, undergoing clinically indicated endovascular therapy (balloon angioplasty, stenting, atherectomy or combination) for lower extremity peripheral artery disease (PAD) and claudication or critical limb ischemia (CLI). Rutherford Category 2-6. Includes iliac lesions, common femoral, superficial femoral artery, popliteal artery and tibial vessels A subject can be enrolled more than once (up to a maximum of two total times) for treatment of a staged lesion but must wait at least 6 weeks from the completion of the last study enrollment. Exclusions: No pregnant females No vulnerable populations (dementia, prisoners, children) Baseline bradycardia (heart rate <50 beats/min) or hypotension (systolic blood pressure <90 mm Hg) will be excluded from receiving adenosine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Translesional Hemodynamic Measurement|Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures | Observational: • During treatment of Lesion a catheter is inserted into the diseased portion of the artery to remove the plaque and improve the blood flow through the artery. This measurement, which may be repeated 5 times during the treatment, to measure the blood flow at a point before and after the section of the artery with the blockage | At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure. |