NCT02877563

Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
OTHER	Contrast ultrasound perfusion imaging of the limb	Contrast enhanced ultrasound imaging at rest and during contractile exercise will be performed prior to revascularization and 3-4 weeks after revascularization.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2016-08-24
• Last updated: 2018-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study