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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: IVUS and OCT Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IVUS Imaging vs. OCT Imaging<br>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<br>* Use of an imaging catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 
| 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: Excellent image; Acceptable image: 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: None; Tolerable/not limiting; 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 Outcome Measures

| Outcome Measure | 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 | Total luminal area is measured from the longest diameter at proximal, middle and distal locations. | During the diagnostic imaging procedures, up to 5 minutes |