Skip to main content
OpenTrials
Completed

NCT Number: NCT03480685

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adventis Midwest Health, Hinsdale, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVUS and OCT Imaging

Device

Use of an imaging catheter

Primary outcomes

  1. Visualization of Vessel Morphology: Layered Structure

    Time frame: 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:

    • clear differentiation of vessel wall layers;
    • differentiation of 3 wall layers;
    • differentiation of 2 wall layers;
    • no differentiation visible

  2. Visualization of Vessel Morphology: Non-layered Structure

    Time frame: 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

  3. Visualization of Vessel Morphology: Calcification

    Time frame: 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.

  4. Visualization of Vessel Morphology: Stent Structure

    Time frame: 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:

    • Excellent image;
    • Acceptable image:
    • Unacceptably poor image.

  5. Visualization of Vessel Morphology: Artifacts

    Time frame: 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:

    • None;
    • Tolerable/not limiting;
    • Is intense and limits image quality.

  6. Freedom From Adverse Events

    Time frame: 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.

Secondary outcomes

  1. Vessel Measurement: Mean Diameter

    Time frame: During the diagnostic imaging procedures, up to 5 minutes

    Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.

  2. Vessel Measurement: Total Luminal Area

    Time frame: During the diagnostic imaging procedures, up to 5 minutes

    Total luminal area is measured from the longest diameter at proximal, middle and distal locations.

Sponsors and collaborators

Lead sponsor

Avinger, Inc.

Industry

Registry information

Official study title

A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging

Acronym: SCAN

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.