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Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

Peripheral Artery Disease Clinical Trial

Official title:
Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

Clinical Trial Summary

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.

Clinical Trial Description

The study will be performed in patients with known history of PAD that are scheduled to undergo either surgical or percutaneous revascularization. Limb rest-stress CEU perfusion imaging will be performed before and 3-4 weeks after revascularization. Quantitative measurements of pre-revascularization perfusion, post-revascularization perfusion, and change in perfusion will be compared to symptom status (Rutherford classification and PAD [Criqui] questionnaire) at each study point, and to data on time to onset of claudication on an upright treadmill exercise study (Gardiner protocol). Results of angiography will be scored and allow determination of the relationship between angiographic severity of disease and exercise perfusion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02877563
Study type Observational
Source Oregon Health and Science University
Contact Jonathan R Lindner, MD
Phone 503 494-9191
Email lindnerj@ohsu.edu
Status Recruiting
Phase
Start date June 1, 2018
Completion date December 31, 2019
View Details
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