An interventional study of IVUS and OCT Imaging in Peripheral Artery Disease, sponsored by Avinger, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Avinger, Inc. · Not applicable, Interventional, and Diagnostic
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).
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.
Exclusion Criteria:
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On day of diagnostic imaging procedures, up to 1 hour
Vessel Measurement: Mean Diameter
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
Vessel Measurement: Total Luminal Area
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
| Milestone | IVUS Imaging vs. OCT Imaging |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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
| score on a scale | IVUS Imaging | OCT Imaging |
|---|---|---|
| Visualization of Vessel Morphology: Layered Structure | 1.61 (1.48 to 1.74) | 1.49 (1.37 to 1.61) |
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
| score on a scale | IVUS Imaging | OCT Imaging |
|---|---|---|
| Visualization of Vessel Morphology: Non-layered Structure | 2.70 (2.53 to 2.87) | 1.82 (1.67 to 1.97) |
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.
| score on a scale | IVUS Imaging | OCT Imaging |
|---|---|---|
| Visualization of Vessel Morphology: Calcification | 2.45 (2.30 to 2.60) | 2.11 (1.92 to 2.30) |
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.
| score on a scale | IVUS Imaging | OCT Imaging |
|---|---|---|
| Visualization of Vessel Morphology: Stent Structure | 1.79 (1.66 to 1.92) | 1.43 (1.34 to 1.55) |
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.
| score on a scale | IVUS Imaging | OCT Imaging |
|---|---|---|
| Visualization of Vessel Morphology: Artifacts | 1.87 (1.77 to 1.97) | 1.79 (1.60 to 1.98) |
Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events.
| Adverse Events | IVUS Imaging | OCT Imaging |
|---|---|---|
| Freedom From Adverse Events | 0 | 0 |
Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
| mm | IVUS Imaging | OCT Imaging |
|---|---|---|
| Proximal Location: Longest Diameter | 4.7 ± 1.2 | 4.7 ± 1.0 |
| Proximal Location: Shortest Diameter | 4.0 ± 1.1 | 3.8 ± 0.9 |
| Middle Location: Longest Diameter | 4.3 ± 1.0 | 4.3 ± 0.9 |
| Middle Location: Shortest Diameter | 3.7 ± 1.0 | 3.5 ± 0.9 |
| Distal Location: Longest Diameter | 3.5 ± 0.9 | 3.5 ± 0.8 |
| Distal Location: Shortest Diameter | 3.0 ± 0.9 | 3.1 ± 0.8 |
Total luminal area is measured from the longest diameter at proximal, middle and distal locations.
| square mm | IVUS Imaging | OCT Imaging |
|---|---|---|
| Proximal Location: Luminal area from longest diameter | 18.55 ± 8.8 | 17.95 ± 7.3 |
| Middle Location: Luminal area from longest diameter | 15.36 ± 6.6 | 14.83 ± 6.3 |
| Distal Location: Luminal area from longest diameter | 10.06 ± 6.2 | 10.26 ± 5.4 |
Collected over On day of diagnostic imaging procedures, up to 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IVUS Imaging | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| OCT Imaging | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
120 matched IVUS and OCT images were collected along defined segments of peripheral vessels from 12 subjects.
| Age, Continuous(years) | IVUS Imaging vs. OCT Imaging |
|---|---|
| Mean | 68 (55 to 87) |
| Sex: Female, Male(Participants) | IVUS Imaging vs. OCT Imaging |
|---|---|
| Female | 2 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | IVUS Imaging vs. OCT Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Weight(kg) | IVUS Imaging vs. OCT Imaging |
|---|---|
| Mean | 82 (69 to 92) |
| Height(cm) | IVUS Imaging vs. OCT Imaging |
|---|---|
| Mean | 176.8 (167.6 to 187.9) |
| Leg of vessel accessed(Participants) | IVUS Imaging vs. OCT Imaging |
|---|---|
| Right Leg | 3 |
| Left Leg | 9 |
| Vessel imaged(Percentage of Participants) | IVUS Imaging vs. OCT Imaging |
|---|---|
| SFA | 64 |
| Popliteal | 36 |
| Mean length of target segment of vessel(cm) | IVUS Imaging vs. OCT Imaging |
|---|---|
| Mean | 24 (10 to 60) |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Avinger, Inc.