Clinical trial NCT03480685: Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Official title: A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Avinger, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 images will be collected into a library and independent readers will rank each image on the quality of vessel morphology and disease.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* if female, pregnant or breast-feeding
* unwilling to give informed consent

Primary outcomes:
measure: Visualization of Vessel Morphology: Layered Structure
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
measure: Visualization of Vessel Morphology: Non-layered Structure
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
measure: Visualization of Vessel Morphology: Calcification
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
measure: Visualization of Vessel Morphology: Stent Structure
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
measure: Visualization of Vessel Morphology: Artifacts
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
measure: Freedom From Adverse Events
timeFrame: On day of diagnostic imaging procedures, up to 1 hour
Secondary outcomes:
measure: Vessel Measurement: Mean Diameter
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
measure: Vessel Measurement: Total Luminal Area
timeFrame: During the diagnostic imaging procedures, up to 5 minutes
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: Adventis Midwest Health
state: Illinois
city: Pottstown
country: United States
facility: Pottstown Hospital
state: Pennsylvania
Study officials:
affiliation: Avinger, Inc.
name: Thomas Lawson, PhD
role: STUDY_DIRECTOR
References:
citation: Pavillard E, Sewall L. A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN). BMC Med Imaging. 2020 Feb 14;20(1):18. doi: 10.1186/s12880-020-0420-7.