Adults 18 to 90, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Visualization of Vessel Morphology: Layered StructurePrimary· 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:
1. clear differentiation of vessel wall layers;
2. differentiation of 3 wall layers;
3. differentiation of 2 wall layers;
4. no differentiation visible
Group
Value
95% CI
IVUS Imaging
1.61
1.48 – 1.74
OCT Imaging
1.49
1.37 – 1.61
Visualization of Vessel Morphology: Non-layered StructurePrimary· 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
Group
Value
95% CI
IVUS Imaging
2.70
2.53 – 2.87
OCT Imaging
1.82
1.67 – 1.97
Visualization of Vessel Morphology: CalcificationPrimary· 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.
Group
Value
95% CI
IVUS Imaging
2.45
2.30 – 2.60
OCT Imaging
2.11
1.92 – 2.30
Visualization of Vessel Morphology: Stent StructurePrimary· 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:
1. Excellent image;
2. Acceptable image:
3. Unacceptably poor image.
Group
Value
95% CI
IVUS Imaging
1.79
1.66 – 1.92
OCT Imaging
1.43
1.34 – 1.55
Visualization of Vessel Morphology: ArtifactsPrimary· 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:
1. None;
2. Tolerable/not limiting;
3. Is intense and limits image quality.
Group
Value
95% CI
IVUS Imaging
1.87
1.77 – 1.97
OCT Imaging
1.79
1.60 – 1.98
Freedom From Adverse EventsPrimary· 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.
Group
Value
95% CI
IVUS Imaging
0
OCT Imaging
0
Vessel Measurement: Mean DiameterSecondary· During the diagnostic imaging procedures, up to 5 minutes
Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
Proximal Location: Longest Diameter
Group
Value
95% CI
IVUS Imaging
4.7
± 1.2
OCT Imaging
4.7
± 1.0
Proximal Location: Shortest Diameter
Group
Value
95% CI
IVUS Imaging
4.0
± 1.1
OCT Imaging
3.8
± 0.9
Middle Location: Longest Diameter
Group
Value
95% CI
IVUS Imaging
4.3
± 1.0
OCT Imaging
4.3
± 0.9
Middle Location: Shortest Diameter
Group
Value
95% CI
IVUS Imaging
3.7
± 1.0
OCT Imaging
3.5
± 0.9
Distal Location: Longest Diameter
Group
Value
95% CI
IVUS Imaging
3.5
± 0.9
OCT Imaging
3.5
± 0.8
Distal Location: Shortest Diameter
Group
Value
95% CI
IVUS Imaging
3.0
± 0.9
OCT Imaging
3.1
± 0.8
Vessel Measurement: Total Luminal AreaSecondary· During the diagnostic imaging procedures, up to 5 minutes
Total luminal area is measured from the longest diameter at proximal, middle and distal locations.
Proximal Location: Luminal area from longest diameter
Group
Value
95% CI
IVUS Imaging
18.55
± 8.8
OCT Imaging
17.95
± 7.3
Middle Location: Luminal area from longest diameter
Group
Value
95% CI
IVUS Imaging
15.36
± 6.6
OCT Imaging
14.83
± 6.3
Distal Location: Luminal area from longest diameter
Group
Value
95% CI
IVUS Imaging
10.06
± 6.2
OCT Imaging
10.26
± 5.4
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Avinger, Inc.
Last refreshed: 14 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03480685.