Trial Outcomes & Findings for Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging (NCT NCT03480685)

Last Updated: 2021-06-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

During the diagnostic imaging procedures, up to 5 minutes

Results posted on

2021-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IVUS Imaging vs. OCT Imaging n=240 Images A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Weight	82 kg n=5 Participants
Height	176.8 cm n=5 Participants
Leg of vessel accessed Right Leg	3 Participants n=5 Participants
Leg of vessel accessed Left Leg	9 Participants n=5 Participants
Vessel imaged SFA	64 Percentage of Participants n=5 Participants
Vessel imaged Popliteal	36 Percentage of Participants n=5 Participants
Mean length of target segment of vessel	24 cm n=5 Participants
Number of images containing a specific vessel characteristic to be scored Layered Structure	24 Images n=5 Participants
Number of images containing a specific vessel characteristic to be scored Nonlayered Structure	104 Images n=5 Participants
Number of images containing a specific vessel characteristic to be scored Calcification	40 Images n=5 Participants
Number of images containing a specific vessel characteristic to be scored Stent Structure	21 Images n=5 Participants
Number of images containing a specific vessel characteristic to be scored Artifact	120 Images n=5 Participants

PRIMARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

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

Outcome measures

Outcome measures
Measure	IVUS Imaging n=24 Images Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=24 Images Same vessel segment imaged with optical coherence tomography (OCT).
Visualization of Vessel Morphology: Layered Structure	1.61 score on a scale Interval 1.48 to 1.74	1.49 score on a scale Interval 1.37 to 1.61

PRIMARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

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

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

Outcome measures

Outcome measures
Measure	IVUS Imaging n=104 Images Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=104 Images Same vessel segment imaged with optical coherence tomography (OCT).
Visualization of Vessel Morphology: Non-layered Structure	2.70 score on a scale Interval 2.53 to 2.87	1.82 score on a scale Interval 1.67 to 1.97

PRIMARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

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

Outcome measures

Outcome measures
Measure	IVUS Imaging n=40 Images Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=40 Images Same vessel segment imaged with optical coherence tomography (OCT).
Visualization of Vessel Morphology: Calcification	2.45 score on a scale Interval 2.3 to 2.6	2.11 score on a scale Interval 1.92 to 2.3

PRIMARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

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

Outcome measures

Outcome measures
Measure	IVUS Imaging n=21 Images Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=21 Images Same vessel segment imaged with optical coherence tomography (OCT).
Visualization of Vessel Morphology: Stent Structure	1.79 score on a scale Interval 1.66 to 1.92	1.43 score on a scale Interval 1.34 to 1.55

PRIMARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

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

Outcome measures

Outcome measures
Measure	IVUS Imaging n=120 Images Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=120 Images Same vessel segment imaged with optical coherence tomography (OCT).
Visualization of Vessel Morphology: Artifacts	1.87 score on a scale Interval 1.77 to 1.97	1.79 score on a scale Interval 1.6 to 1.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IVUS Imaging n=12 Participants Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=12 Participants Same vessel segment imaged with optical coherence tomography (OCT).
Freedom From Adverse Events	0 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.

Outcome measures

Outcome measures
Measure	IVUS Imaging n=12 Participants Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=12 Participants Same vessel segment imaged with optical coherence tomography (OCT).
Vessel Measurement: Mean Diameter Proximal Location: Longest Diameter	4.7 mm Standard Deviation 1.2	4.7 mm Standard Deviation 1.0
Vessel Measurement: Mean Diameter Proximal Location: Shortest Diameter	4.0 mm Standard Deviation 1.1	3.8 mm Standard Deviation 0.9
Vessel Measurement: Mean Diameter Middle Location: Longest Diameter	4.3 mm Standard Deviation 1.0	4.3 mm Standard Deviation 0.9
Vessel Measurement: Mean Diameter Middle Location: Shortest Diameter	3.7 mm Standard Deviation 1.0	3.5 mm Standard Deviation 0.9
Vessel Measurement: Mean Diameter Distal Location: Longest Diameter	3.5 mm Standard Deviation 0.9	3.5 mm Standard Deviation 0.8
Vessel Measurement: Mean Diameter Distal Location: Shortest Diameter	3.0 mm Standard Deviation 0.9	3.1 mm Standard Deviation 0.8

SECONDARY outcome

Timeframe: During the diagnostic imaging procedures, up to 5 minutes

Total luminal area is measured from the longest diameter at proximal, middle and distal locations.

Outcome measures

Outcome measures
Measure	IVUS Imaging n=12 Participants Vessel segment imaged with intravascular ultrasound (IVUS).	OCT Imaging n=12 Participants Same vessel segment imaged with optical coherence tomography (OCT).
Vessel Measurement: Total Luminal Area Proximal Location: Luminal area from longest diameter	18.55 square mm Standard Deviation 8.8	17.95 square mm Standard Deviation 7.3
Vessel Measurement: Total Luminal Area Middle Location: Luminal area from longest diameter	15.36 square mm Standard Deviation 6.6	14.83 square mm Standard Deviation 6.3
Vessel Measurement: Total Luminal Area Distal Location: Luminal area from longest diameter	10.06 square mm Standard Deviation 6.2	10.26 square mm Standard Deviation 5.4

Adverse Events

IVUS Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OCT Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Lawson, PhD

Avinger, Inc.

Phone: 650-241-7030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place