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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03480685

Acronym

SCAN

Enrollment

Registered

2018-03-29

Start date

2018-05-24

Completion date

2018-10-01

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

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.

Interventions

DEVICEIVUS and OCT Imaging

Use of an imaging catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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: 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: 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.
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 visible
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 quality
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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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).	12
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).	240
Total	252

Baseline characteristics

Characteristic	IVUS Imaging vs. OCT Imaging
Age, Continuous	68 years
Height	176.8 cm
Leg of vessel accessed Left Leg	9 Participants
Leg of vessel accessed Right Leg	3 Participants
Mean length of target segment of vessel	24 cm
Number of images containing a specific vessel characteristic to be scored Artifact	120 Images
Number of images containing a specific vessel characteristic to be scored Calcification	40 Images
Number of images containing a specific vessel characteristic to be scored Layered Structure	24 Images
Number of images containing a specific vessel characteristic to be scored Nonlayered Structure	104 Images
Number of images containing a specific vessel characteristic to be scored Stent Structure	21 Images
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	11 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	10 Participants
Vessel imaged Popliteal	36 Percentage of Participants
Vessel imaged SFA	64 Percentage of Participants
Weight	82 kg

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 12
other Total, other adverse events	0 / 12	0 / 12
serious Total, serious adverse events	0 / 12	0 / 12

Outcome results

Primary

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

Arm	Measure	Value (NUMBER)
IVUS Imaging	Freedom From Adverse Events	0 Adverse Events
OCT Imaging	Freedom From Adverse Events	0 Adverse Events

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: 1. None; 2. Tolerable/not limiting; 3. Is intense and limits image quality.