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

Peripheral Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480685
• Other study ID #: P0986
• Status: Completed
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: June 2021
• Source: Avinger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• IVUS and OCT Imaging
Use of an imaging catheter

Locations

Country	Name	City	State
United States	Adventis Midwest Health	Hinsdale	Illinois
United States	Pottstown Hospital	Pottstown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Avinger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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