Peripheral Arterial Disease Clinical Trial
Official title:
TRanslesIonal Assessment of Gradients During Endovascular Therapy
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
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. ;
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