Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?

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Narrowing or occlusion of the arteries of the lower limb, caused by atherosclerotic lesions, can lead to leg pain, ulceration and ultimately amputation. Endovascular revascularisation is a procedure in which the artery opened through the use of balloons or stents inserted under the guidance of a special x-ray technique called angiography. These procedures have a high rate of failure with about half developing a >/=50% narrowing (or restenosis) within a year. Much of this failure rate is attributed to technical factors such as incorrect size of catheter or incorrect positioning and in part may relate to the limited view provided by angiography. Intravascular ultrasound (IVUS) is an alternative imaging method that provides a more complete view of the artery. It has been shown that IVUS adds more information when combined with angiography but it is unclear whether this results in changes to treatment and whether this then results in better outcomes for patients. This aim of this study is to investigate whether the addition of IVUS improves the outcomes for endovascular revascularisation. This is a randomised control trial comparing endovascular revascularisation procedures guided by angiography with procedures guided by both angiography and IVUS. The study sample of 150 patients will be recruited from patients requiring treatment of lesions in the superficial femoral or popliteal arteries. Patients will be randomised into two groups of equal size; a control group having angiography guidance only and a second group having both angiography and IVUS guidance. All patients will have non-invasive tests of endothelial function (tests of the functioning the inner surface of the artery – an essential component in maintaining vascular wellbeing) before their and after the procedure as well as the standard blood tests and regular surveillance imaging that is normally scheduled for patients after these procedures. The primary outcome measure will be >/=50% restenosis of the treated artery. This degree of restenosis requires re-intervention to reopen the artery. At this point the original procedure will be deemed to have failed for the purposes of analysis. The restenosis rate will be compared for each group.