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

NCT03480685 | Completed Results FDA Device

• 1 other identifier: P0986
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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).

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (6)

• 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: 1. clear differentiation of vessel wall layers; 2. differentiation of 3 wall layers; 3. differentiation of 2 wall layers; 4. 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: 1. Excellent image; 2. Acceptable image: 3. 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: 1. None; 2. Tolerable/not limiting; 3. 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 Outcomes (2)

• Vessel Measurement: Mean Diameter

  During the diagnostic imaging procedures, up to 5 minutes

• Vessel Measurement: Total Luminal Area

  During the diagnostic imaging procedures, up to 5 minutes

Study Arms (1)

IVUS Imaging vs. OCT Imaging

OTHER

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

Interventions

IVUS and OCT Imaging DEVICE

Use of an imaging catheter

IVUS Imaging vs. OCT Imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Avinger, Inc.: lead

Study Sites (2)

Adventis Midwest Health

Hinsdale, Illinois, 60521, United States

Location

Pottstown Hospital

Pottstown, Pennsylvania, 19464, United States

Location

Related Publications (1)

• 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.

  PMID: 32059702 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Thomas Lawson, PhD
• Organization: Avinger, Inc.

tlawson@avinger.com

650-241-7030

Study Officials

• Thomas Lawson, PhD

  Avinger, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: May 24, 2018
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)