Peripheral Arterial Disease Clinical Trial
Official title:
Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging (REVASC-PI)
Contrast ultrasound perfusion imaging (CUPI) is a novel tool for the assessment of muscle perfusion deficits in peripheral arterial disease (PAD). In this study we want to examine the effect of bypass surgery and balloon angioplasty on the calf muscle blood supply. We hope find a new way of quantifying success or failure of invasive treatment strategies.
Contrast ultrasound perfusion imaging (CUPI) was developed at the University Hospital of
Freiburg, Germany in 2005 for the assessment of skeletal muscle perfusion deficits in
peripheral arterial disease (PAD). It has been reported previously by the investigators that
the contrast agent wash-in is significantly prolonged in PAD with respect to the extent of
disease and with respect to the degree of collateralization.
The goal of this study is to examine the effect of revascularization procedures on muscular
perfusion in 15 PAD patients undergoing lower limb artery bypass surgery and 15 PAD patients
undergoing percutaneous angioplasty (PTA) before and after intervention. Based on the data
from a pilot study, a power calculation for an alpha = 5% with a power of 80% and an assumed
standard deviation of 10 s yielded a necessary patient number of 29 per group to detect a
decrease in wash-in time of 7.5 s. In this intra-individual comparison we aim to compare 30
patients pre with the same 30 patients post revascularization.
We hypothesize 1) that the contrast agent wash-in in the target muscle will significantly
improve after revascularization and 2) that standard non-invasive tests such ankle-brachial
index (ABI) will not correlate with the CUPI findings. The results of this trial will help to
further understand the diagnostic accuracy of CUPI in quantifying limb muscle perfusion
deficits.
Patients with symptomatic PAD and an indication for revascularization will undergo CUPI less
than 8 weeks prior and less than 3 weeks after the revascularization procedure. A second
follow-up CUPI examination is performed 3 - 6 months after the revascularization procedure.
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