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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS and OCT Imaging | Device | Use of an imaging catheter |
|
| 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:
| 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:
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Lawson, PhD | Avinger, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adventis Midwest Health | Hinsdale | Illinois | 60521 | United States | ||
| Pottstown Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32059702 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
120 matched IVUS and OCT images were collected along defined segments of peripheral vessels from 12 subjects.
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Twenty-four imaging pairs of the 120 imaging pairs (240 images total) were analyzed for layered structures. | Posted | Mean | 95% Confidence Interval | score on a scale | During the diagnostic imaging procedures, up to 5 minutes | Images | Images |
|
On day of diagnostic imaging procedures, up to 1 hour
Method of systematic assessment: any adverse events during the diagnostic imaging procedure are recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVUS Imaging | Vessel segment imaged with intravascular ultrasound (IVUS). | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lawson, PhD | Avinger, Inc. | 650-241-7030 | tlawson@avinger.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2018 | Mar 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 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:
| 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 |
Total luminal area is measured from the longest diameter at proximal, middle and distal locations.
| During the diagnostic imaging procedures, up to 5 minutes |
| Pottstown |
| Pennsylvania |
| 19464 |
| United States |
| Images |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Weight | Mean | Full Range | kg | Participants |
|
| Height | Mean | Full Range | cm | Participants |
|
| Leg of vessel accessed | Count of Participants | Participants | Participants |
|
| Vessel imaged | Number | Percentage of Participants | Participants |
|
| Mean length of target segment of vessel | Mean | Full Range | cm | Participants |
|
| Number of images containing a specific vessel characteristic to be scored | Number | Images | Participants |
|
| OG001 | OCT Imaging | Same vessel segment imaged with optical coherence tomography (OCT). |
|
|
| 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 | One hundred and four imaging pairs of the 120 imaging pairs (240 images total) were analyzed for non-layered structures. | Posted | Mean | 95% Confidence Interval | score on a scale | During the diagnostic imaging procedures, up to 5 minutes | Images | Images |
|
|
|
| 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. | Forty imaging pairs of the 120 imaging pairs (240 images total) were analyzed for calcification. | Posted | Mean | 95% Confidence Interval | score on a scale | During the diagnostic imaging procedures, up to 5 minutes | Images | Images |
|
|
|
| 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:
| Twenty-one imaging pairs of the 120 imaging pairs (240 images total) were analyzed for stent structure. | Posted | Mean | 95% Confidence Interval | score on a scale | During the diagnostic imaging procedures, up to 5 minutes | Images | Images |
|
|
|
| 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:
| One hundred and twenty imaging pairs (240 images total) were analyzed for artifacts. | Posted | Mean | 95% Confidence Interval | score on a scale | During the diagnostic imaging procedures, up to 5 minutes | Images | Images |
|
|
|
| Primary | Freedom From Adverse Events | Primary safety endpoint is freedom from diagnostic imaging procedure-related and device-associated adverse events. | Posted | Number | Adverse Events | On day of diagnostic imaging procedures, up to 1 hour |
|
|
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| Secondary | Vessel Measurement: Mean Diameter | Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations. | Posted | Mean | Standard Deviation | mm | During the diagnostic imaging procedures, up to 5 minutes |
|
|
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| Secondary | Vessel Measurement: Total Luminal Area | Total luminal area is measured from the longest diameter at proximal, middle and distal locations. | Posted | Mean | Standard Deviation | square mm | During the diagnostic imaging procedures, up to 5 minutes |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | OCT Imaging | Same vessel segment imaged with optical coherence tomography (OCT). | 0 | 12 | 0 | 12 | 0 | 12 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Middle Location: Longest Diameter |
|
| Middle Location: Shortest Diameter |
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| Distal Location: Longest Diameter |
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| Distal Location: Shortest Diameter |
|
| Distal Location: Luminal area from longest diameter |
|