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

• Sponsor: Avinger, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03480685
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Actual Duration (Months): 4.3
• Patients Per Site: 6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	Device: IVUS and OCT Imaging	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging
• Actual Study Start Date: May 24, 2018
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	Device: IVUS and OCT Imaging; Use of an imaging catheter

Outcome Measures

Primary Outcome Measures

1. 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: clear differentiation of vessel wall layers; differentiation of 3 wall layers; differentiation of 2 wall layers; no differentiation visible

2. 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

3. 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.

4. 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: Excellent image; Acceptable image: Unacceptably poor image.

5. 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: None; Tolerable/not limiting; Is intense and limits image quality.

6. 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.

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adventis Midwest Health	Hinsdale	Illinois	United States	60521
2	Pottstown Hospital	Pottstown	Pennsylvania	United States	19464

Sponsors and Collaborators

• Avinger, Inc.

Investigators

• Study Director: Thomas Lawson, PhD, Avinger, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 22, 2018

More Information

Publications

None provided.

• Responsible Party: Avinger, Inc.
• ClinicalTrials.gov Identifier: NCT03480685
• Other Study ID Numbers: P0986
• First Posted: Mar 29, 2018
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

Participant Flow

Arm/Group Title	IVUS Imaging vs. OCT Imaging
Arm/Group Description	A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	IVUS Imaging vs. OCT Imaging
Arm/Group Description	A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).
Overall Participants	12
Overall Images	240
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68
Sex: Female, Male (Count of Participants)
Female	2 16.7%
Male	10 83.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 8.3%
White	11 91.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Weight (kg) [Mean (Full Range) ]
Mean (Full Range) [kg]	82
Height (cm) [Mean (Full Range) ]
Mean (Full Range) [cm]	176.8
Leg of vessel accessed (Count of Participants)
Right Leg	3 25%
Left Leg	9 75%
Vessel imaged (Percentage of Participants) [Number]
SFA	64 533.3%
Popliteal	36 300%
Mean length of target segment of vessel (cm) [Mean (Full Range) ]
Mean (Full Range) [cm]	24
Number of images containing a specific vessel characteristic to be scored (Images) [Number]
Layered Structure	24
Nonlayered Structure	104
Calcification	40
Stent Structure	21
Artifact	120

Outcome Measures

1. Primary Outcome

Title	Visualization of Vessel Morphology: Layered Structure
Description	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
Time Frame	During the diagnostic imaging procedures, up to 5 minutes

Outcome Measure Data

Analysis Population Description

Twenty-four imaging pairs of the 120 imaging pairs (240 images total) were analyzed for layered structures.

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Measure Images	24	24
Mean (95% Confidence Interval) [score on a scale]	1.61	1.49

2. Primary Outcome

Title	Visualization of Vessel Morphology: Non-layered Structure
Description	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

Outcome Measure Data

Analysis Population Description

One hundred and four imaging pairs of the 120 imaging pairs (240 images total) were analyzed for non-layered structures.

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Measure Images	104	104
Mean (95% Confidence Interval) [score on a scale]	2.70	1.82

3. Primary Outcome

Title	Visualization of Vessel Morphology: Calcification
Description	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

Outcome Measure Data

Analysis Population Description

Forty imaging pairs of the 120 imaging pairs (240 images total) were analyzed for calcification.

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Measure Images	40	40
Mean (95% Confidence Interval) [score on a scale]	2.45	2.11

4. Primary Outcome

Title	Visualization of Vessel Morphology: Stent Structure
Description	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.
Time Frame	During the diagnostic imaging procedures, up to 5 minutes

Outcome Measure Data

Analysis Population Description

Twenty-one imaging pairs of the 120 imaging pairs (240 images total) were analyzed for stent structure.

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Measure Images	21	21
Mean (95% Confidence Interval) [score on a scale]	1.79	1.43

5. Primary Outcome

Title	Visualization of Vessel Morphology: Artifacts
Description	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.
Time Frame	During the diagnostic imaging procedures, up to 5 minutes

Outcome Measure Data

Analysis Population Description

One hundred and twenty imaging pairs (240 images total) were analyzed for artifacts.

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Measure Images	120	120
Mean (95% Confidence Interval) [score on a scale]	1.87	1.79

6. Primary Outcome

Title	Freedom From Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Number [Adverse Events]	0	0

7. Secondary Outcome

Title	Vessel Measurement: Mean Diameter
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Proximal Location: Longest Diameter	4.7 (1.2)	4.7 (1.0)
Proximal Location: Shortest Diameter	4.0 (1.1)	3.8 (0.9)
Middle Location: Longest Diameter	4.3 (1.0)	4.3 (0.9)
Middle Location: Shortest Diameter	3.7 (1.0)	3.5 (0.9)
Distal Location: Longest Diameter	3.5 (0.9)	3.5 (0.8)
Distal Location: Shortest Diameter	3.0 (0.9)	3.1 (0.8)

8. Secondary Outcome

Title	Vessel Measurement: Total Luminal Area
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IVUS Imaging	OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).	Same vessel segment imaged with optical coherence tomography (OCT).
Measure Participants	12	12
Proximal Location: Luminal area from longest diameter	18.55 (8.8)	17.95 (7.3)
Middle Location: Luminal area from longest diameter	15.36 (6.6)	14.83 (6.3)
Distal Location: Luminal area from longest diameter	10.06 (6.2)	10.26 (5.4)

Adverse Events

Time Frame	On day of diagnostic imaging procedures, up to 1 hour
Adverse Event Reporting Description	Method of systematic assessment: any adverse events during the diagnostic imaging procedure are recorded.
Arm/Group Title	IVUS Imaging		OCT Imaging
Arm/Group Description	Vessel segment imaged with intravascular ultrasound (IVUS).		Same vessel segment imaged with optical coherence tomography (OCT).
All Cause Mortality
	IVUS Imaging		OCT Imaging
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	IVUS Imaging		OCT Imaging
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	IVUS Imaging		OCT Imaging
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.