Peripheral Artery DiseaseSCANNCT03480685

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

A study testing IVUS and OCT Imaging in people with Peripheral Artery Disease, run by Avinger, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Peripheral Artery Disease
What is being tested?: IVUS and OCT Imaging
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesUnited States
Study dates: 24 May 2018to 1 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

if female, pregnant or breast-feeding
unwilling to give informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Adventis Midwest Health
Hinsdale, Illinois, 60521
Pottstown Hospital
Pottstown, Pennsylvania, 19464

Other trials in United States

About this study

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

Read the 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.

Conditions: Peripheral Artery Disease
Being tested: IVUS and OCT Imaging
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVUS and OCT ImagingDevice
Use of an imaging catheter

Study groups in NCT03480685
Study group	Role	What they receive
IVUS Imaging vs. OCT Imaging	Other	A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT). Receives: Device: IVUS and OCT Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On day of diagnostic imaging procedures, up to 1 hour

Secondary outcomes (2)

Vessel Measurement: Mean Diameter
Mean diameter measurements include longest and shortest diameter at proximal, middle, and distal locations.
Measured: 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.
Measured: During the diagnostic imaging procedures, up to 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 20181 Oct 2018

First posted29 Mar 2018
Study start24 May 2018
Primary completion1 Aug 2018
Study completion1 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03480685
Sponsor's protocol ID: P0986
Acronym: SCAN
Status last verified: Jun 2021
First submitted: 22 Mar 2018
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pavillard E, Sewall L. A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN). BMC Med Imaging. 2020 Feb 14;20(1):18. doi: 10.1186/s12880-020-0420-7.
PubMed 32059702

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
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Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
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Recruiting
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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03480685
Acronym / sponsor ID: SCAN / P0986
Conditions: Peripheral Artery Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Avinger, Inc.Industry (pharma, biotech, devices)
Study start: 24 May 2018 (actual)
Primary completion: 1 Aug 2018 (actual)
Study completion: 1 Oct 2018 (actual)
First posted: 29 Mar 2018 (actual)
Results: Posted 14 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IVUS Imaging vs. OCT Imaging	Other	Device: IVUS and OCT ImagingA vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

if female, pregnant or breast-feeding
unwilling to give informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IVUS and OCT ImagingUse of an imaging catheter	Device	IVUS Imaging vs. OCT Imaging

Primary outcome

Visualization of Vessel Morphology: Layered Structure
Time frame: 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
Time frame: 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
Time frame: 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.
Visualization of Vessel Morphology: Stent Structure
Time frame: 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
Time frame: 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.
Freedom From Adverse Events
Time frame: 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.

2 secondary outcomes

Vessel Measurement: Mean Diameter
Time frame: During the diagnostic imaging procedures, up to 5 minutes
Vessel Measurement: Total Luminal Area
Time frame: During the diagnostic imaging procedures, up to 5 minutes

Results and safety

Results posted to the registry on 14 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IVUS Imaging vs. OCT Imaging	12	12

Primary outcome: Visualization of Vessel Morphology: Layered Structure

Time frame: During the diagnostic imaging procedures, up to 5 minutes. Mean (95% Confidence Interval). Unit: score on a scale

Measure	IVUS Imaging n = 12	OCT Imaging n = 12
Value	1.61 (1.48 to 1.74)	1.49 (1.37 to 1.61)

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

Primary outcome: Visualization of Vessel Morphology: Non-layered Structure

Time frame: During the diagnostic imaging procedures, up to 5 minutes. Mean (95% Confidence Interval). Unit: score on a scale

Measure	IVUS Imaging n = 12	OCT Imaging n = 12
Value	2.70 (2.53 to 2.87)	1.82 (1.67 to 1.97)

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

Primary outcome: Visualization of Vessel Morphology: Calcification

Time frame: During the diagnostic imaging procedures, up to 5 minutes. Mean (95% Confidence Interval). Unit: score on a scale

Measure	IVUS Imaging n = 12	OCT Imaging n = 12
Value	2.45 (2.30 to 2.60)	2.11 (1.92 to 2.30)

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

Primary outcome: Visualization of Vessel Morphology: Stent Structure

Time frame: During the diagnostic imaging procedures, up to 5 minutes. Mean (95% Confidence Interval). Unit: score on a scale

Measure	IVUS Imaging n = 12	OCT Imaging n = 12
Value	1.79 (1.66 to 1.92)	1.43 (1.34 to 1.55)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: On day of diagnostic imaging procedures, up to 1 hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IVUS Imaging	0 of 12 (0%)	0 of 12 (0%)	0 of 12
OCT Imaging	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32059702Pavillard E, Sewall L. A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN). BMC Med Imaging. 2020 Feb 14;20(1):18. doi: 10.1186/s12880-020-0420-7.
Individual participant dataSharing planned: No

Related trials for Peripheral Artery Disease

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SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
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Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Lawson, PhD study director

Avinger, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IVUS and OCT Imaging in people with Peripheral Artery Disease, run by Avinger, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visualization of Vessel Morphology: Layered Structure (time frame: During the diagnostic imaging procedures, up to 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.