Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: IVUS and OCT Imaging

• Registration Number: NCT03480685
• Lead Sponsor: Avinger, Inc.

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.

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Study Start: 2018-05-24
• Primary Completion: 2018-08-01
• Study Completion: 2018-10-01
• Results First Submitted: 2021-03-18
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-10
• Results First Posted: 2021-06-14
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IVUS Imaging vs. OCT Imaging	IVUS and OCT Imaging	A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).

Primary Outcome Measures

Name	Time	Method
Visualization of Vessel Morphology: Calcification	During the diagnostic imaging procedures, up to 5 minutes	The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing images for calcification.; Images were scored on a scale from 1 to 5. A lower score means better image quality and a higher score means worse image quality.; Scoring Scale for image quality for calcification: 1- Excellent histology-like image quality to 5- Unacceptably poor image quality.
Freedom From Adverse Events	On day of diagnostic imaging procedures, up to 1 hour	Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events.
Visualization of Vessel Morphology: Layered Structure	During the diagnostic imaging procedures, up to 5 minutes	The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing layered structures.; Images were scored on a scale from 1 to 4. A lower score means better image quality and a higher score means worse image quality.; Scoring Scale for image quality of layered structure: 1. clear differentiation of vessel wall layers; 2. differentiation of 3 wall layers; 3. differentiation of 2 wall layers; 4. no differentiation visible
Visualization of Vessel Morphology: Stent Structure	During the diagnostic imaging procedures, up to 5 minutes	The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing stent structure.; Images were scored on a scale from 1 to 3. A lower score means better image quality and a higher score means worse image quality.; Scoring Scale for image quality of Stent Structure: 1. Excellent image; 2. Acceptable image: 3. Unacceptably poor image.
Visualization of Vessel Morphology: Non-layered Structure	During the diagnostic imaging procedures, up to 5 minutes	The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing non-layered structures.; Images were scored on a scale from 1 to 5. A lower score means better image quality and a higher score means worse image quality.; Scoring scale for image quality of non-layered structure: 1-Excellent histology-like image quality to 5-unacceptably poor image quality
Visualization of Vessel Morphology: Artifacts	During the diagnostic imaging procedures, up to 5 minutes	The primary endpoint was met when OCT imaging had the equivalent or lower mean score than IVUS imaging when comparing imaging artifacts.; Images were scored on a scale from 1 to 3. A lower score means better image quality and a higher score means worse image quality.; Scoring Scale for image quality of artifacts: 1. None; 2. Tolerable/not limiting; 3. Is intense and limits image quality.

Secondary Outcome Measures

Name	Time	Method
Vessel Measurement: Mean Diameter	During the diagnostic imaging procedures, up to 5 minutes	Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
Vessel Measurement: Total Luminal Area	During the diagnostic imaging procedures, up to 5 minutes	Total luminal area is measured from the longest diameter at proximal, middle and distal locations.

Trial Locations

Locations (2)

Pottstown Hospital; 🇺🇸 Pottstown, Pennsylvania, United States

Adventis Midwest Health; 🇺🇸 Hinsdale, Illinois, United States