Status:
COMPLETED
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Lead Sponsor:
Avinger, Inc.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS)...
Detailed Description
Patients requiring diagnostic imaging of peripheral vessels to determine vessel condition and planning treatment strategy will have vessel segments imaged by both OCT and IVUS imaging catheters. The i...
Eligibility Criteria
Inclusion
- adult
- suspected vascular disease that might be a candidate for IVUS
- reference vessel can accommodate imaging catheters
- successful diagnostic imaging and removal of IVUS catheter with no adverse events
Exclusion
- if female, pregnant or breast-feeding
- unwilling to give informed consent
Key Trial Info
Start Date :
May 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03480685
Start Date
May 24 2018
End Date
October 1 2018
Last Update
June 14 2021
Active Locations (2)
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1
Adventis Midwest Health
Hinsdale, Illinois, United States, 60521
2
Pottstown Hospital
Pottstown, Pennsylvania, United States, 19464