A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral Arteries for Diagnostic Purposes Comparing Optical Coherence Tomography and Intravascular Ultrasound Imaging
Phase: NA
Conditions: Peripheral Artery Disease
Sponsor: Avinger, Inc.

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The SCAN Trial 
Protocol Number: P0986 
A Post-market, Multi-vessel Evaluation of the Imaging of Peripheral 
Arteries for Diagnostic PurposeS Comparing Optical Coherence 
TomogrAphy and INtravascular Ultrasound Imaging 
CONFIDENTIAL 
INVESTIGATOR USE ONLY 
SPONSOR 
Avinger, Inc. 
400 Chesapeake Drive 
Redwood City, CA 94063 
SPONSOR CONTACT 
Thomas Lawson, PhD 
400 Chesapeake Drive 
Redwood City, CA 94063 
(650) 241-7030
tlawson@avinger.com 
NCT03480685

 
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TABLE OF CONTENTS 
1. 
INTRODUCTION .................................................................................................................. 4 
2. 
DEVICE AND TECHNOLOGY DESCRIPTION ................................................................. 4 
2.1. 
Pantheris System and Catheter ............................................................................................ 4 
2.2. 
VISIONS IVUS catheter ..................................................................................................... 6 
3. 
RISK/BENEFIT ASSESSMENT ........................................................................................... 8 
3.1. 
Risks .................................................................................................................................... 8 
3.2. 
Benefits ............................................................................................................................... 8 
4. 
CURRENT INDICATIONS FOR USE FOR THE TWO DEVICES .................................... 9 
4.1. 
Pantheris System’s Current Indications for Use ................................................................. 9 
5. 
INVESTIGATIONAL PLAN ................................................................................................. 9 
5.1. 
Study Design Overview ...................................................................................................... 9 
5.2. 
Sample Size Estimate ........................................................................................................ 10 
5.3. 
Study Endpoints ................................................................................................................ 10 
5.4. 
Enrollment and Study Duration ........................................................................................ 11 
5.5. 
Duration of Subject Participation ...................................................................................... 11 
6. 
STUDY PROCEDURE ........................................................................................................ 11 
7. 
SAFETY AND DEVICE MALFUNCTION REPORTING................................................. 14 
7.1. 
Safety Reporting ............................................................................................................... 14 
7.2. 
Device Malfunction and/or Device Failure Reporting ...................................................... 14 
8. 
DEVICE AVAILABILITY .................................................................................................. 15 
9. 
GOOD CLINICAL PRACTICES (GCP) ............................................................................. 15 
9.1. 
Institutional Review Board (IRB) Approval ..................................................................... 15 
9.2. 
Informed Consent .............................................................................................................. 15 
9.3. 
Amending the Protocol ..................................................................................................... 15 
9.4. 
Subject Confidentiality ..................................................................................................... 15 
9.5. 
Coverage of Expenses ....................................................................................................... 16 
9.6. 
Compensation in the Event of Injury ................................................................................ 16 
9.7. 
Data Monitoring and Quality Control ............................................................................... 16 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................ 16 
10.1. 
Site Training .................................................................................................................. 16 
10.2. 
Physician Training ........................................................................................................ 16 

 
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10.3. 
Audits and Inspections .................................................................................................. 17 
11. 
STUDY MONITORING AND ADMINISTRATION ..................................................... 17 
11.1. 
Source Documentation .................................................................................................. 17 
11.2. 
Criteria for Terminating the Study ................................................................................ 17 
11.3. 
Criteria for Suspending/Terminating a Study Center ................................................... 18 
11.4. 
Sponsor Responsibilities ............................................................................................... 18 
11.5. 
Investigator Responsibilities ......................................................................................... 18 
11.6. 
Protocol Deviations ....................................................................................................... 19 
12. 
Literature Cited ................................................................................................................. 19 
APPENDIX A – Protocol Signature Page .................................................................................... 20 
 
 
 
 

 
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1. INTRODUCTION 
 
Intravascular imaging provides clinicians with information essential to the development of 
treatment strategy and avoidance of procedure-associated injuries to the vessel walls. Two 
primary modalities of such imaging are intravascular ultrasound (IVUS) and optical 
coherence tompography (OCT). Both have advantages and challenges for use in assessing 
occlusions and structures in peripheral arteries. 
 
As the name denotes, IVUS uses high-frequency sound waves that rebound off vessel walls 
and are collected by a processing system. The intensity of the waves vary depending on the 
tissue encountered and the system electronics process those signals to create a cross-
sectional image.1 It is used to measure plaque extent, morphology and distribution, but has 
low resolution and calcium deposits in the vessel walls can reduce penetration of the sound 
waves.2,3 OCT imaging uses near-infrared light to optimize intravascular visualization of 
tissue. OCT images have higher resolution and faster imaging acquisition than IVUS,4 but 
imaging requires management of blood flow, which can interfere with light transmission.5 
2. DEVICE AND TECHNOLOGY DESCRIPTION  
The devices that will be used in this study are the Pantheris (Avinger, Inc.) and the Visions 
(Royal Philips Corp.) catheters. Both devices have been reviewed by the United States’s 
Food and Drug Administration (FDA) and have marketing clearance for commercial use 
and use in diagnostic imaging in peripheral vessels. Neither device is considered 
investigational or experimental and in this study they will be used in accordance with their 
FDA-cleared indications for use.  
 
2.1. Pantheris System and Catheter 
The Pantheris system is comprised of the Pantheris catheter (Figure 1), Lightbox 
Imaging Sled (Sled), and the Lightbox HS Imaging Console (Lightbox). The catheter 
is connected to the Lightbox via the Sled and it is the Lightbox Console that displays 
the OCT images captured by the catheter’s rotating laser.  The Sled provides optical 
and rotational power to the Pantheris catheter. 
The Pantheris catheter is a monorail (rapid exchange) device with a working length of 
110 cm and is compatible with a 0.014” guidewire.  The Pantheris is designed for 
treatment of lesions in vessels with a diameter of 3 mm to 7 mm. The catheter is 
provided sterile and is for single use only.  
 
OCT imaging can differentiate neointimal morphology and its capability of 
determining stent malapposition, tissue protrusion around and through stent structure, 
and stent edge dissection allows the clinican to make decisions about treatment 
strategy (Figure 2). The system also has the capability to measure the diameter of the 
lumen of the vessel. 
 
 
 

 
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FIGURE 1:  PANTHERIS SYSTEM ELEMENTS; THE CATHETER (TOP), THE SLED 
(LOWER LEFT) AND THE LIGHTBOX (LOWER RIGHT). 
 
 
 
 
 
 

 
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FIGURE 2:  VESSEL ANATOMY VISIBLE WITH OCT IMAGING BY THE  
PANTHERIS CATHETER. 
 
 
 
2.2. VISIONS IVUS catheter 
 
The Visions PV 0.014P IVUS catheter (Visions catheter) has a working length of 150 cm 
and is advanced through an indwelling vascular sheath, following an 0.014” guide wire. 
The catheter is connected with an imaging system that displays the images (Figure 3). The 
IVUS catheter permits the clinician to assess disease markers, such as plaque burden and 
lesion location and morphology, as well as provide measurements of the lumen of the 
vessel. It is provided sterile and for single use only. 
 

 
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FIGURE 3:  THE VISIONS IVUS IMAGING SYSTEM AND CONSOLE (A), AND  
VISIONS IVUS CATHETER (B). 
 
                                        
 
                                                               
                                   FIGURE 4:  VESSEL MORPHOLOGY AS IMAGED BY AN IVUS CATHETER. 
 
 

 
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3. RISK/BENEFIT ASSESSMENT 
3.1. 
Risks 
Introduction of either the Pantheris or Visions catheter into a peripheral artery 
carries some known risks. 
 
Adverse effects possible with the use of the Pantheris OCT and Visions IVUS 
catheters include, but are not limited to, the following events: 
• Vessel dissection, perforation, rupture or injury; 
• Restenosis; 
• Hemorrhage or hematoma; 
• Infection; 
• Vessel spasm; 
• Embolism; 
• Entry puncture site bleeding; 
• Vessel thrombosis; 
• Renal failure; 
• Vessel trauma requiring surgical repair or intervention; and 
• Death. 
 
The patients involve in this study diagnostic imaging and the possible risks for 
diagnostic include, but are not limited to, the following events:  
• Entry site complications 
• Entry site pain 
• Acute vessel closure 
• Arterial rupture 
• Arterial spasm 
• Bleeding complications 
• Infection 
 
There are risks associated with the use of medical equipment connected to an 
energy source.  These risks have been mitigated through in-house testing and 
compliance.   
 
Risk will be mitigated by working with an Investigator who is experienced and 
skilled in endovascular diagnostic techniques.  Additionally, only Investigators 
with experience of proper device operation will participate in this study. 
 
3.2. 
Benefits 
Knowledge gained in this study on the use of OCT or IVUS systems to assist in 
diagnosis and treatment planning may provide physicians with an additional option 
that is as good or better than what is available currently for visualization of vessel 
morphology during the procedure.  
 

 
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4. CURRENT INDICATIONS FOR USE FOR THE TWO DEVICES 
4.1. 
Pantheris System’s Current Indications for Use 
The Pantheris System’s OCT imaging system being used in this study was 
originally cleared under K152275 in October of 2015, with device iterations being 
reviewed in subsequent regulatory submissions. The device has been commercially 
available since 2016.   
 
The Indications for Use statement for the Pantheris system is: 
“The Pantheris System is intended to remove plaque (atherectomy) from 
partially occluded vessels in the peripheral vasculature with a reference 
diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging.  
The system is an adjunct to fluoroscopy by providing images of vessel 
lumen, wall structures and vessel morphologies.  The Pantheris System is 
NOT intended for use in the iliac, coronary, cerebral, renal or carotid 
vasculature.” 
 
The Pantheris catheter was cleared for diagnostic use under K162326. 
 
4.2. VISIONS PV 0.014P’s Current Indications for Use 
 
 
 
The Visions 0.014P device being used in this study was originally cleared by the 
FDA under K152829 in November 2015. The device is available commercially. 
 
The Indications for Use statement for the Visions PV 0.014 IVUS catheter system 
is: 
 
“The Visions PV 0.014 IVUS catheter is designed for use in the evaluation 
of vascular morphology in blood vessels of the coronary and peripheral 
vasculature by providing a cross-sectional image of such vessels. This 
device is not currently indicated for use in cerebral vessels. It is designed 
for use as an adjunct to conventional angiographic procedures to provide an 
image of the vessel lumen and wall structures.” 
 
5. INVESTIGATIONAL PLAN 
5.1. 
Study Design Overview 
The purpose of this is a study to collect images of the same vessel segments using 
both the IVUS and OCT systems so that a comparison can be made of the two 
imaging modalities. IVUS and OCT images will be captured at identical positions 
within vessel segments.  Continuous imaging will occur as the catheters are moved 
from distal to proximal endpoints established with a radiopaque marking tape 
attached to the subject’s leg. 
 

 
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The trial will enroll up to 25 subjects diagnosed with peripheral arterial disease of 
the lower extremities, with the goal to acquire at least 115 matched images for 
analysis. 
 
The images will be anonymized and given a unique identification prior to 
assessment by three radiologists (readers) for review. The readers will review the 
images and rank each for image clarity (using a visual analogue scale or VAS) and 
identification of vessel morphology and disease pre- and post-procedure. 
 
The inclusion criteria for subjects are:  
1. 
Subject is an adult ( >18 years old); and 
2. 
With suspected vascular disease that might be a candidate for IVUS; and 
3. 
Reference vessel lumen is acceptable for use of the Pantheris and IVUS  
catheters as per visual angiographic estimation. 
4. 
Successful diagnostic imaging and removal of the IVUS catheter with no 
adverse events. 
 
The exclusion criteria are:  
1. 
Subject, if female, is pregnant or breast feeding; or 
2. 
Subject is unwilling to give informed consent.  
 
5.2. 
Sample Size Estimate 
When the sample size is 108 images of both the OCT and IVUS catheters, a two 
group 0.05 one-sided matched t-test will have 90% power to reject the null 
hypothesis that the test (OCT) and standard (IVUS) are not equivalent in favor of 
the alternative hypothesis that the two groups are equivalent. To obtain 108 vessel 
segment images at five images per subject, 22 subjects would be needed; however, 
recognizing that some images (~ 5%) may be of poor quality and illegible, 25 
subjects should be enrolled and 115 images evaluated. 
5.3. 
Study Endpoints 
Primary efficacy endpoint is met when OCT imaging has the equivalent or higher 
ranking of IVUS imaging of the visualization of vessel morphology and disease 
for: 
o Layered structure – intima, media, external elastic lamina, and adventitia; 
o Non-layered structure—presence of disease in the vessel structure; 
o Abnormal physiology—dissection/tissue flap/false lumen, thrombus, 
calcium;  
o Bifurcation of the vessel; and 
o Frequency of artifacts. 
 
Secondary efficacy endpoint is met when OCT imaging has the equivalent 
dimensions of vessel diameter and total luminal area as that determined with IVUS 
imaging. 
 

 
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Primary safety endpoint is freedom from diagnostic imaging procedure-related and 
device-associated adverse events, as reported by the physician. 
5.4. 
Enrollment and Study Duration 
Subjects will be enrolled at 3 clinical sites in the USA. 
 
Subjects will be considered enrolled into the study once the consent form is signed 
and the Pantheris catheter is introduced into the vasculature.  Subjects will be 
considered exited from the study once the Pantheris catheter (OCT device) 
diagnostic imaging and vessel measurements have been completed. Enrollment is 
expected to start in Q1 2018, and conclude by the end of Q2 2018.  
 
Subjects may withdraw at any time from the study without prejudice or detriment 
to their medical care.  If a subject prematurely terminates from the study, the reason 
for the termination will be recorded. Subjects who actively withdraw from the trial 
will be considered “withdrawals.” If termination is a result of an adverse event or 
death, an Adverse Event Case Report Form will also be completed.   
  
5.5. 
Duration of Subject Participation 
Participation lasts the duration of the diagnostic imaging procedure.  No follow-up 
imaging or patient data will be collected.  
 
6. STUDY PROCEDURE 
 
6.1 
Gathering OCT and IVUS Images 
 
After providing informed consent, the subject will be prepared for the diagnostic 
procedure according to the institution’s and investigator’s standard procedures. 
Demographic information will be recorded for each subject. 
 
A radiopaque ruler will be attached to the subject’s leg to provide reference marks 
for starting and stopping points of the “target segment” that will be used for image 
acquisition by the two devices.  
 
Subjects will undergo diagnostic angiographic images to identify the  target segment 
starting poing (distal end) and ending point (proximal end) which will be between 5 
cm and 10 cm within the vessel.   
 
A 7 Fr vascular sheath will be advanced up-and-over the aortic bifurcation and to 
the region of interest of the artery.  
 
A 0.014 inch guide wire will be advanced distal to the target segment under 
angiographic imaging.    
 

 
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An IVUS catheter will be loaded onto the wire and advanced until its imaging 
transducer resides at the distal end of the target segment (starting point). Using the 
radiopaque ruler as a reference of the starting point (distal end) and stopping point 
(proximal end) of the target segment, the IVUS catheter will be energized for 
imaging and retracted through the target segment (between 5 cm and 10 cm within 
the vessel) capturing images within the target segment.  
 
The diameter of the lumen of the vessel at the starting, mid, and ending points of the 
target segment will measured using the IVUS system software. Mean diameter and 
luminal area will be calculated for each target segment imaged. 
 
After all images and measurments of the target segment have been captured on the 
IVUS system, the IVUS catheter will be removed. 
 
Using the radiopaque ruler as a reference, an OCT catheter will be advanced over 
the 0.014 guide wire until its imaging window is at the exact same starting point 
(distal end) of the target segment.  Once the OCT catheter is inserted, the subject is 
enrolled in the study.  With the device energized, the OCT catheter will be retracted 
through the exact same target segment of the vessel and the OCT images captured 
on the Lightbox system. 
 
The diameter of the lumen of the vessel at the starting, mid, and ending points of the 
target segment will measured using the OCT system software. Mean diameter and 
luminal area will be calculated for each target segment imaged. 
 
After all images and measurments of the target segment have been captured on the 
OCT system, the subject is exited from the study.  Once the subject is exited from 
the study, the investigator can choose to remove the OCT catheter or use it to 
perform atherectomy. 
 
IVUS images will be collected either on DICOM and stored on a hard drive or saved 
to an S-VHS and then transferred to a PC hard-drive for processing, per the clinic’s 
standard protocol. OCT images will be captured on the Lightbox and downloaded 
to a memory stick or external hard drive or DVD. 
 
6.2 Analysis of Images 
 
The trial will acquire at least 115 matched images for analysis by three independent 
readers who are experienced radiologists and were not involved in the cases during 
which these images were captured. Sample images of IVUS and OCT will be 
reviewed prior to the image assessment to create a consistent nomenclature for the 
readers when identifying different tissue types with both imaging modalities and 
standardize the image review process. The images will be anonymized and given a 
unique identification number prior to assessment by the readers. Since the 
presentation of IVUS and OCT images are visibly different, the readers cannot be 
blinded as to which imaging device used to generate the image, but the images will 

 
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be provided in a random sequence so that the reader cannot match a specific IVUS 
image to a specific OCT image at the time of the review. 
 
The readers will view the images and rank each for clarity (using a visual analogue 
scale or VAS) and identification of vessel morphology and disease pre- and post-
procedure. 
 
Qualitative interpretation of OCT and IVUS images will be ranked as follows: 
 on) for: 
o Layered structure – intima, media, external elastic lamina and adventitia 
(ranked as 1- clear differentiation of the vessel wall layers, 2- differentiation 
of at least three vessel wall layers, 3- differentiation of at least two vessel 
wall layers, and 4- no differentiation of any vessel wall layer); 
o Non-layered structure—presence of disease in the vessel structure (a 5-
point VAS  of 1- excellent histology-like image quality to 5- unacceptably 
poor image quality); 
o Abnormal physiology—dissection/tissue flap/false lumen, thrombus, 
calcium (a 5-point VAS  of 1- excellent histology-like image quality to 5- 
unacceptably poor image quality);  
o Bifurcation of the vessel (1- excellent image, 2- acceptable image, 3- 
unacceptably poor image quality); and 
o Frequency of artifacts (ranked as 1- no artifacts, 2- tolerable/not limiting 
diagnostic image quality, 3- intense and limits diagnostic image quality). 
 
The results of all readings of both imaging modalities will be used for 
intrareader and interreader comparison to evaluate the reproducibility and 
reliability of the respective imaging modality. 
 
 6.3   Statistical Analyses 
 
Statistical analyses will be carried out using StatView software (SAS Institute, 
Cary, NC). A p value < 0.05 will be considered statistically significant. Matched 
Pairs t-Test will be performed to compare means and on paired samples to compare 
procedural data and complications associated with the imaging techniques. The 
mean values of the results of all readings of all readers will be calculated for 
comparison of image quality. Fisher’s Exact Test will be used to compare 
proportions. The Mann-Whitney-Wilcoxon test will be applied for statistical 
comparison of the results for OCT and IVUS imaging. Interreader and intrareader 
reproducibility will be calculated by intraclass correlation (ICC) analysis in a two-
way mixed model. Correlation of the mean values of the results of the quantitative 
measurements of all readers with both imaging modalities will be calculated as 
Pearson correlation coefficient. 
 
 
 

 
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7. SAFETY AND DEVICE MALFUNCTION REPORTING 
7.1. 
Safety Reporting 
Incidence and severity of procedure-related and device-related adverse events (e.g., 
vessel spasm, thrombosis, distal embolism, etc.) will be evaluated following each 
scan and documented over the course of the study. All adverse events (AEs) will 
be are required to be completely documented through Avinger’s complaint 
handling process.. 
 
The following events will be considered to be serious adverse events (SAEs) and 
must be reported to the Sponsor by telephone, fax and/or email. These events must 
be reported whether or not the Investigator believes they are related to study 
procedures, activities or device: 
• Death; 
• Life-threatening event; 
• Disability – significant, persistent, or permanent change, impairment, or 
damage or disruption in the subject’s body function/structure, physical 
activities or quality of life; 
• Necessitate immediate medical or surgical intervention to: 
- Preclude permanent impairment of a body function or permanent damage 
to a body structure 
- Relieve unanticipated temporary impairment or damage; or 
• Prolongation of a hospitalization. 
 
It is the responsibility of the Investigator to inform their Institutional Review Board 
(IRB) of serious adverse events as required by their IRB’s procedures and in 
conformance with local regulatory requirements.   
 
7.2. 
Device Malfunction and/or Device Failure Reporting 
All reported device malfunctions or failures of the Pantheris Catheter, Imaging 
Sled, or Lightbox Console are required to be completely documented through 
Avinger’s complaint handling process. All malfunctions or suspected failures of the 
Pantheris catheter shall be returned to Avinger for analysis with instructions 
provided by Avinger.  Any malfunctions or suspected failures of the IVUS device 
should be reported to its manufacturer. 
 
NOTE: Device failures or malfunctions are NOT to be reported as adverse events. 
However, if there is an adverse event associated with a device failure or 
malfunction, the specific event should be recorded on the adverse event report form. 
 
 
 
 

 
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8. DEVICE AVAILABILITY 
IVUS devices will be drawn from the institution’s inventory. Avinger will provide 
sterile units of the Pantheris catheter for use in this study at no charge to the 
institution. 
 
9. GOOD CLINICAL PRACTICES (GCP) 
The trial will be performed in accordance with the relevant parts of ISO 14155-
1/14155-2.1; the ICH Guidelines for Good Clinical Practices (E6), the Declaration 
of Helsinki, and any regional and/or national regulations.  
9.1. 
Institutional Review Board (IRB) Approval 
Prior to study initiation, this protocol and the informed consent document must be 
submitted to an IRB for written approval. The IRBs written notification of approval 
will be provided to Avinger prior to study commencement. Any changes to the 
protocol that may increase study risks or present new risks to the subject or may 
adversely affect the outcome of the study must be approved in writing by the study 
Sponsor and the site IRB before the change is made.  
9.2. 
Informed Consent 
Prior to participation in the clinical trial, each subject must give written Informed 
Consent after the study has been fully explained to the subject in language that is 
easily understood by the subject. The subjects must also be given the opportunity 
to ask questions and have those questions answered to their satisfaction. The subject 
will receive a copy of the Informed Consent form. 
 
The Informed Consent document provided to subjects will be in accordance with 
the current guidelines as outlined by the Good Clinical Practices (GCP) guidelines, 
Declaration of Helsinki and the International Conference on Harmonization (ICH).  
9.3. 
Amending the Protocol 
An Investigator may not make protocol changes without prior approval by Avinger 
and other oversight bodies.  
 
Any requested change to this protocol must be submitted to Avinger for review and 
agreement, followed by approval by the IRB. The investigative sites must send 
Avinger a copy of the IRB approval letter for a protocol amendment. 
9.4. 
Subject Confidentiality 
All information concerning subjects or their participation in this trial will be 
considered confidential. Only authorized Avinger personnel and designated 
consultants will have access to these confidential files. Enrolled subjects will be 
assigned a unique identifier that will be used to maintain confidentiality of subjects’ 
medical information. Subject names and other protected health information will not 
be captured on the case report forms. In addition, angiographic, IVUS, and OCT 

 
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images submitted from the participating site to the Sponsor should be redacted of 
all subject identifiers. 
9.5. 
Coverage of Expenses 
The treated subjects will not be compensated for participating in the study.  
9.6. 
Compensation in the Event of Injury 
Both devices are being used as intended and following FDA-reviewed and cleared 
instructions for use. The cost of any treatment for any injury sustained during this 
study will be the obligation of the subject and/or the subject’s insurance. 
9.7. 
Data Monitoring and Quality Control 
All collected data will be verified for accuracy with source documents including, 
but not limited to, medical records, office/clinic notes, procedure reports, laboratory 
results, physician and nursing progress notes. Verification and quality of data, 
monitoring of clinical study progress and Investigator compliance with the 
approved protocol will be conducted by Avinger or its designated representative. 
 
Telephone and/or e-mail contact will be conducted by Avinger on a regular basis 
with the Investigator and the site staff to ensure that the protocol is being followed 
and to address any issues that may occur during the course of the trial. 
 
If a deficiency is noted during the course of the trial, the site’s clinical monitor is 
required to bring this to the attention of Avinger to discuss the situation and (if 
required) to secure compliance. 
 
10.     QUALITY CONTROL AND QUALITY ASSURANCE 
10.1. Site Training 
To ensure accurate, complete, and reliable data, the Sponsor or its representatives 
will provide instructional material to the trial sites, as appropriate, and:  
• Instruct the Investigators and trial personnel on the protocol and the completion 
of the CRF; 
• Communicate regularly with site personnel via mail, email, telephone, and/or 
fax; and 
• Make periodic visits to the trial sites (if applicable). 
 
During those visits, the Sponsor or its representatives will monitor the subject data 
recorded in the CRF against source documents at the trial site. 
10.2. Physician Training 
Prior to enrolling subjects in the trial, Investigators will be trained on the data 
required for completion of the CRF. 
 
 
 

 
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10.3. Audits and Inspections 
The Principal Investigator for the site will allow representatives of the governing 
IRB, the United States Food and Drug Administration (FDA), and other applicable 
regulatory agencies to inspect all study records. These inspections are for the 
purpose of verifying adherence to the protocol, completeness and exactness of the 
data being reported and compliance with FDA regulations. 
 
The Principal Investigator for the site will inform the Sponsor or the Sponsor’s 
designee in advance if they are to be audited or inspected by any regulatory 
agencies. The Sponsor or the Sponsor’s designee will also inform the site if they 
are made aware of a pending audit or inspection by a regulatory agency. 
 
11. STUDY MONITORING AND ADMINISTRATION 
Avinger will make necessary efforts to ensure that this study is conducted in 
compliance with GCPs and all applicable regulatory requirements. 
11.1. Source Documentation 
The Investigator must maintain detailed source documents on all trial subjects who 
are enrolled in the trial. Source documents include subject medical records, hospital 
charts, clinic charts, Investigator’s subject trial files, as well as the results of 
diagnostic tests (e.g., laboratory tests). 
 
The following minimum information should be recorded in the subject’s medical 
records: 
• The date the subject entered the trial and the subject number; 
• The trial protocol number and the name of the Sponsor; 
• The date that informed consent was obtained; 
• Evidence that the subject meets trial eligibility requirements (e.g., medical 
history, trial procedures and/or evaluations); 
• The dates of all trial-related subject visits; 
• Evidence that required procedures and/or evaluations were completed; 
• Use of any concurrent medications; 
• Documentation of specific device used; 
• Occurrence and status of any Adverse Events; and 
• The date the subject exited the trial, and a notation as to whether the subject 
completed the trial or was discontinued, including the reason for 
discontinuation. 
11.2. Criteria for Terminating the Study 
Avinger reserves the right to terminate the study but intends only to exercise this 
right for valid scientific or administrative reasons related to protection of subjects. 
Investigators and associated IRBs will be notified in writing in the event of 
termination. 
 
 

 
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11.3. Criteria for Suspending/Terminating a Study Center 
Avinger reserves the right to stop enrollment of subjects at a particular study center 
at any time after the study initiation visit if no subjects have been enrolled or if the 
center has multiple or severe protocol violations without justification or fails to 
follow remedial actions. 
 
Possible reasons for suspending/terminating a study center include: 
• Repeated failure to complete case report forms prior to scheduled monitoring 
visits; 
• Failure to obtain written Informed Consent; 
• Failure to report SAEs/UADEs to Avinger; or 
• Loss of (or unaccounted for) product inventory. 
11.4. Sponsor Responsibilities 
As the study Sponsor, Avinger, Inc. of Redwood City, California, is committed to 
the following: 
• Obtaining Institutional Review Board approval for the Protocol and Informed 
Consent Form (ICF) from the central IRB (WIRB) prior to enrolling subjects; 
• Selecting qualified Investigators; 
• Ensuring proper Investigator training; 
• Ensuring proper clinical site support and monitoring; 
• Ensuring that the central IRB is informed of any significant new information 
about the study; 
• Maintaining accurate and complete study records and submitting required 
reports; 
• Obtaining signed Investigator Protocol Signature pages; 
• Providing case report forms and ensuring that completed forms match source 
documentation; 
• Ensuring protocol compliance; and 
• Ensuring proper reporting of all AEs. 
11.5. Investigator Responsibilities 
All Investigators involved in this trial will sign an Investigator’s Agreement 
affirming that they will adhere to the following activities: 
• Submitting the site specific ICF to the central IRB and securing approval; 
• Ensuring that enrolled subjects comply with the inclusion/exclusion criteria; 
• Obtaining written IRB approval prior to subject enrollment; 
• Obtaining written informed consent from each subject prior to enrollment; 
• Performing the study evaluations as described in this protocol; 
• Maintaining source documentation in the subject’s medical files; 
• Completing case report forms corroborated by source documentation; 
• Submitting required reports to the study Sponsor and IRB, if necessary; 
• Complying with the study protocol and reporting any deviations in advance of 
their occurrence; 
• Maintaining study related records; and 
• Maintaining accurate records related to device accountability. 

 
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11.6. Protocol Deviations 
A protocol deviation is defined as an event where the Investigator or site personnel 
did not conduct the study according to the protocol. 
 
Investigators shall be required to obtain prior approval from Avinger clinical study 
management before initiating deviations from the protocol, except where necessary 
to protect the life or physical well-being of a subject in an emergency. Such 
approval shall be documented in writing and maintained in clinical study 
management and Investigator files. Prior approval is generally not expected in 
situations where unforeseen circumstances are beyond the Investigator’s control, 
(e.g., subject was not available for scheduled follow-up office visit, blood sample 
lost by laboratory, etc.); however, the event is still considered a deviation and will 
be reported via the CRF. 
 
Deviations must be reported to Avinger regardless of whether medically justifiable, 
pre-approved by Avinger or taken to protect the subject in an emergency. Subject 
specific deviations will be reported on the CRF. Non-subject specific deviations, 
(e.g., unauthorized use of an study device outside the study, unauthorized use of an 
study device by a physician who is not a participating investigator or not been 
trained in the use of the device, etc.), will be reported to Avinger via the CRF.  
Investigators will also adhere to procedures for reporting study deviations to the 
IRB in accordance with the central IRB reporting policies and procedures. 
 
Regulations require that Investigators maintain accurate, complete and current 
records, including documents showing the dates of and reasons for each deviation 
from the protocol.   
 
 
12.   Literature Cited 
 
1. Makris GC, et al. The role of intravascular ultrasound in lower limb revaMiscularization in 
patients with peripheral arterial disease. International Angiology 2017; 36: 505-516.. 
2. Singh T, et al. Tissue removal by ultrasound evaluation (the TRUE study): the Jetstream G2 
system post-market peripheral vascular IVUS study. J Invasive Cardiol 2011; 23(7): 269-273. 
3. Kashyap VS, et al. In vivo assessment of endothelial function in human lower extremity  
arteries. J Vasc Surg 2013; 58(5): 1259-1266. 
4. Eberhardt KM et al. Prospective evaluation of optical coherence tomography in lower limb 
arteries compared with intravascular ultrasound JVIR 2013; 24: 1499-1508. 
5. MacNeill BD, et al. Intravascular modalities for detection of vulnerable plaque: current status. 
MisArteroscler Thromb Vasc Biol 2003; 23: 1333-1342. 
 
 
 

 
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APPENDIX A – Protocol Signature Page 
 
 
The SCAN Trial  
 
Protocol Number: P0986 
 
I have read the protocol and agree to comply with all the contents contained herein. I will make a 
reasonable effort to conduct the study in a timely and efficient manner and will ensure that all 
participating staff members are adequately trained to carry out the tasks for which they have been 
assigned. 
 
I will provide access to the study Sponsor and/or its designated representative as well as any 
regulatory agency personnel. I further understand that the study may be terminated or enrollment 
suspended at any time by the study Sponsor, regulatory authorities or the IRB in the event the 
subjects’ best interests may be compromised or the results of ongoing Investigators deem the study 
Sponsor’s product to be unsafe. 
 
 
INVESTIGATOR’S SIGNATURE: 
 
 
_____________________________________________________________________ 
Investigator’s Printed Name 
 
 
 
_____________________________________________________________________ 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
SPONSOR’S SIGNATURE: 
 
 
 
_____________________________________________________________________ 
Thomas Lawson, PhD 
 
 
 
 
 
Date 
VP, Clinical and Regulatory Affairs 
Avinger, Inc.