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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Use of an imaging catheter
Adventis Midwest Health
Hinsdale, Illinois, United States
Pottstown Hospital
Pottstown, Pennsylvania, United States
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.
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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