A Safety and Feasibility Study of Intraprocedural Physiology Measurements During Peripheral Endovascular Treatment

Endovascular treatment for peripheral arterial disease is commonly performed for claudication or critical limb threatening ischaemia (ischaemic rest pain, foot ulcer or gangrene). Disease is generally identified using Ankle Brachial Pressure Index or Toe Brachial Pressure Index and then lesions delineated using Doppler ultrasound or CT angiography. Clinical severity is staged using absolute walking distance (metres) in claudicants or the Society for Vascular Surgery wIfI (wound, ischaemia, foot infection) score in critical limb threatening ischaemia patients.

Intra-procedural lesion assessment and quality control is currently performed anatomically using angiography alone, with a few centres using pullback pressures across a lesion to give supplementary trans-lesional gradients or intravascular ultrasound (IVUS) to give pre and post intervention diameter and vessel area measurements. No direct or quantitative assessment of flow, or pressure normalisation across lesions is currently performed during interventions to improve blood flow to the leg.