Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

Status unconfirmed

Conditions studied: Peripheral Artery Disease

In brief

This study represents an important step to validate the use of contrast-enhanced ultrasound (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be used to accurately assess therapeutic improvements in tissue perfusion that are linked to symptom improvement.

Key facts

Study ID

NCT02877563

Run by

Oregon Health and Science University

People needed

30

Starts

2018-06-01

Expected to finish

2019-12-31

Last updated by the study team

2018-08-23

Who can join

Age: 19 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of symptomatic PAD
• Rutherford score <6
• Age ≥18 y.o.
• Scheduled to undergo surgical or percutaneous revascularization

You may not qualify if…

• Major medical illness affecting the limb other than PAD (muscle disease, neuromuscular disease, blood diseases).
• Pregnant or lactating females (- HCG in women of child bearing age)
• Hypersensitivity to any ultrasound contrast agent
• Evidence right-to-left, bi-directional, or transient cardiac shunt; unexplained pulmonary hypertension (PA systolic pressure >40 mm Hg) or more than moderate reduction in left ventricular systolic function identified on screening echo.
• Allergy to eggs
• Inability to perform modest plantar flexion exercise

Where it is running

• OHSU — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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