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

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVUS and OCT Imaging
Sponsored by
Avinger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adventis Midwest Health
  • Pottstown Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IVUS Imaging vs. OCT Imaging

Arm Description

A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).

Outcomes

Primary Outcome Measures

Visualization of Vessel Morphology: Layered Structure
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
Visualization of Vessel Morphology: Non-layered Structure
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: Calcification
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.
Visualization of Vessel Morphology: Stent Structure
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.
Visualization of Vessel Morphology: Artifacts
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.
Freedom From Adverse Events
Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events.

Secondary Outcome Measures

Vessel Measurement: Mean Diameter
Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
Vessel Measurement: Total Luminal Area
Total luminal area is measured from the longest diameter at proximal, middle and distal locations.

Full Information

First Posted
March 22, 2018
Last Updated
June 10, 2021
Sponsor
Avinger, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03480685
Brief Title
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
Acronym
SCAN
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avinger, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVUS Imaging vs. OCT Imaging
Arm Type
Other
Arm Description
A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).
Intervention Type
Device
Intervention Name(s)
IVUS and OCT Imaging
Intervention Description
Use of an imaging catheter
Primary Outcome Measure Information:
Title
Visualization of Vessel Morphology: Layered Structure
Description
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
Time Frame
During the diagnostic imaging procedures, up to 5 minutes
Title
Visualization of Vessel Morphology: Non-layered Structure
Description
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
Time Frame
During the diagnostic imaging procedures, up to 5 minutes
Title
Visualization of Vessel Morphology: Calcification
Description
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.
Time Frame
During the diagnostic imaging procedures, up to 5 minutes
Title
Visualization of Vessel Morphology: Stent Structure
Description
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.
Time Frame
During the diagnostic imaging procedures, up to 5 minutes
Title
Visualization of Vessel Morphology: Artifacts
Description
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.
Time Frame
During the diagnostic imaging procedures, up to 5 minutes
Title
Freedom From Adverse Events
Description
Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events.
Time Frame
On day of diagnostic imaging procedures, up to 1 hour
Secondary Outcome Measure Information:
Title
Vessel Measurement: Mean Diameter
Description
Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
Time Frame
During the diagnostic imaging procedures, up to 5 minutes
Title
Vessel Measurement: Total Luminal Area
Description
Total luminal area is measured from the longest diameter at proximal, middle and distal locations.
Time Frame
During the diagnostic imaging procedures, up to 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lawson, PhD
Organizational Affiliation
Avinger, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Adventis Midwest Health
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Pottstown Hospital
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32059702
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.
Results Reference
derived

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

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