Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT03480685
- Lead Sponsor
- Avinger, Inc.
- Brief 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- if female, pregnant or breast-feeding
- unwilling to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Visualization of Vessel Morphology: Calcification 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.Freedom From Adverse Events 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.
Visualization of Vessel Morphology: Layered Structure 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 visibleVisualization of Vessel Morphology: Stent Structure 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.Visualization of Vessel Morphology: Non-layered Structure 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 qualityVisualization of Vessel Morphology: Artifacts 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.
- Secondary Outcome Measures
Name Time Method Vessel Measurement: Mean Diameter During the diagnostic imaging procedures, up to 5 minutes Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
Vessel Measurement: Total Luminal Area During the diagnostic imaging procedures, up to 5 minutes Total luminal area is measured from the longest diameter at proximal, middle and distal locations.
Related Research Topics
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Trial Locations
- Locations (2)
Adventis Midwest Health
🇺🇸Hinsdale, Illinois, United States
Pottstown Hospital
🇺🇸Pottstown, Pennsylvania, United States
Adventis Midwest Health🇺🇸Hinsdale, Illinois, United States