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

A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing 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).

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: IVUS and OCT Imaging

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Adventis Midwest Health
  • Pennsylvania
    • Pottstown, Pennsylvania, United States, 19464
      • Pottstown Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IVUS Imaging vs. OCT Imaging; A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).	Device: IVUS and OCT Imaging; Use of an imaging catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the diagnostic imaging procedures, up to 5 minutes
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	During the diagnostic imaging procedures, up to 5 minutes
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.	During the diagnostic imaging procedures, up to 5 minutes
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.	During the diagnostic imaging procedures, up to 5 minutes
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.	During the diagnostic imaging procedures, up to 5 minutes
Freedom From Adverse Events	Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events.	On day of diagnostic imaging procedures, up to 1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Avinger, Inc.
• Investigators: Study Director: Thomas Lawson, PhD, Avinger, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: P0986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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