Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
Conditions: Coronary Artery Disease, Coronary Stenosis
Sponsor: Abbott Medical Devices



 
Study Name: FUSION Study 
Clinical Investigation Plan  
 
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TABLE OF CONTENTS 
1.0 
INTRODUCTION ........................................................................................................................... 8 
1.1 
Background and Rationale ......................................................................................................... 8 
 
Background ........................................................................................................................ 8 
 
Rationale for Conducting this Clinical Investigation ........................................................... 10 
2.0 
CLINICAL INVESTIGATION OVERVIEW .................................................................................... 11 
2.1 
Clinical Investigation Objective................................................................................................. 11 
 
Primary objective .............................................................................................................. 11 
2.2 
Device(s) To Be Used in the Clinical Investigation ................................................................... 11 
 
Name of the Device(s) ...................................................................................................... 11 
 
Indication for Use .............................................................................................................. 12 
 
Description of the Device(s) .............................................................................................. 12 
 
Summary of Preclinical Studies ........................................................................................ 13 
3.0 
CLINICAL INVESTIGATION DESIGN ......................................................................................... 13 
3.1 
Clinical Investigation Procedures Schedule ............................................................................. 13 
3.2 
Measures Taken to Avoid and Minimize Bias ........................................................................... 15 
 
Blinding and Unblinding .................................................................................................... 15 
 
OCT and Physiology Core Laboratory .............................................................................. 15 
3.3 
Suspension or Early Termination of the Clinical Investigation .................................................. 16 
4.0 
ENDPOINTS ............................................................................................................................... 16 
4.1 
Co-Primary Endpoints and Rationale ....................................................................................... 16 
4.2 
Secondary Endpoints ............................................................................................................... 16 
5.0 
SUBJECT SELECTION AND WITHDRAWAL ............................................................................. 17 
5.1 
Subject Population ................................................................................................................... 17 
5.2 
Subject Screening and Informed Consent ................................................................................ 17 
 
Subject Screening ............................................................................................................. 17 
 
Informed Consent ............................................................................................................. 17 
5.2.2.1 
Special Circumstances for Informed Consent ............................................................ 18 
5.3 
Eligibility Criteria ...................................................................................................................... 19 
 
General Eligibility Criteria .................................................................................................. 19 
 
Inclusion Criteria ............................................................................................................... 19 

 
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Clinical Investigation Plan  
 
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General Exclusion Criteria ................................................................................................ 19 
 
Imaging and Pressure Tracing Exclusion Criteria .............................................................. 20 
5.4 
Subject Enrollment ................................................................................................................... 20 
 
Enrollment of Medicare Beneficiaries ................................................................................ 21 
 
Historically Under-Represented Demographic Subgroups ................................................ 21 
5.5 
Subject Discontinuation ........................................................................................................... 21 
5.6 
Number of Subjects ................................................................................................................. 22 
5.7 
Total Expected Duration of the Clinical Investigation................................................................ 22 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS ................................................................... 22 
6.1 
Baseline/Pre-procedure/Pre-treatment ..................................................................................... 22 
 
Baseline Assessments ...................................................................................................... 22 
 
Baseline and Post-PCI Imaging Assessments .................................................................. 23 
 
Pre-procedure CIP-Required Medications......................................................................... 23 
6.2 
PCI Procedure ......................................................................................................................... 23 
 
Physiological indices measurement procedures................................................................ 23 
 
OCT procedures ............................................................................................................... 24 
 
Multiple target lesions/vessels treatment........................................................................... 24 
 
Non-target lesion/vessel treatment.................................................................................... 25 
 
Staged procedure considerations ..................................................................................... 25 
 
Bifurcation lesions consideration ....................................................................................... 25 
6.3 
Post–PCI (In-hospital) .............................................................................................................. 27 
6.4 
Follow-up Assessments ........................................................................................................... 27 
6.5 
Additional Information on Required Assessments .................................................................... 27 
 
Schedule of Events ........................................................................................................... 28 
6.6 
Physiology and OCT Core Laboratories ................................................................................... 29 
7.0 
ADVERSE EVENTS .................................................................................................................... 29 
7.1 
Definition .................................................................................................................................. 29 
 
Adverse Event .................................................................................................................. 29 
 
Serious Adverse Event ..................................................................................................... 30 
 
Device Deficiency/Device Malfunction .............................................................................. 30 
7.2 
Device Relationship ................................................................................................................. 30 

 
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7.3 
Adverse Event and Device Deficiency/Device Malfunction Reporting....................................... 30 
 
Adverse Event Reporting .................................................................................................. 30 
 
Device Deficiency/Malfunction Reporting .......................................................................... 31 
 
Adverse Event Reporting to Country Regulatory Authorities by the Sponsor .................... 32 
8.0 
STATISTICAL CONSIDERATIONS ............................................................................................. 32 
8.1 
Analysis Populations ................................................................................................................ 32 
8.2 
Statistical Analyses .................................................................................................................. 32 
 
Primary Endpoint(s) Analyses ........................................................................................... 32 
8.2.1.1 
Primary Endpoint: Overall Sensitivity ......................................................................... 33 
8.2.1.2 
Primary Endpoint: Overall Specificity ......................................................................... 34 
 
Secondary Endpoint(s) Analyses ...................................................................................... 34 
8.2.2.1 
Secondary Endpoint #1: Overall diagnostic accuracy ................................................ 34 
8.2.2.2 
Secondary Endpoint #2: Positive predictive value (PPV) ........................................... 35 
8.2.2.3 
Secondary Endpoint #3: Negative predictive value (NPV) .......................................... 35 
8.2.2.4 
Secondary Endpoint #4: Correlation between VFR and FFR ..................................... 35 
8.2.2.5 
Secondary Endpoint #5: Area under curve (AUC) against FFR.................................. 35 
8.3 
Sample Size Calculation and Assumptions .............................................................................. 36 
8.4 
Timing of Analysis .................................................................................................................... 37 
8.5 
Subgroup Analysis ................................................................................................................... 37 
8.6 
Multiplicity ................................................................................................................................ 37 
8.7 
Pooling Strategy ...................................................................................................................... 37 
8.8 
Procedures for Accounting for Missing Data ............................................................................ 37 
8.9 
Planned Interim Analysis.......................................................................................................... 37 
8.10 
Statistical Criteria for Termination ............................................................................................ 37 
8.11 
Success Criteria ....................................................................................................................... 37 
8.12 
Deviations from Statistical Plan ................................................................................................ 37 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ............................................................... 38 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................... 38 
10.1 
Selection of Clinical Sites and Investigators ............................................................................. 38 
10.2 
Clinical Investigation Finances and Agreements ...................................................................... 38 
10.3 
CIP Amendments ..................................................................................................................... 38 

 
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10.4 
Training.................................................................................................................................... 38 
 
Site Training ..................................................................................................................... 38 
10.5 
Monitoring ................................................................................................................................ 39 
10.6 
Deviations from CIP ................................................................................................................. 39 
10.7 
Quality Assurance Audit ........................................................................................................... 40 
10.8 
Sponsor Auditing ..................................................................................................................... 40 
10.9 
Committees.............................................................................................................................. 40 
 
Steering Committee .......................................................................................................... 40 
 
Publications Committee .................................................................................................... 41 
11.0 
DATA HANDLING AND RECORD KEEPING .............................................................................. 41 
11.1 
Protection of Personally Identifiable Information ...................................................................... 41 
11.2 
Data Management Plan ........................................................................................................... 42 
11.3 
Source Documentation ............................................................................................................ 42 
11.4 
Case Report Form Completion................................................................................................. 43 
11.5 
Record Retention ..................................................................................................................... 43 
11.6 
Devices Accountability ............................................................................................................. 43 
12.0 
ETHICAL CONSIDERATION....................................................................................................... 43 
12.1 
Institutional Review Board Review and Approval ..................................................................... 43 
13.0 
CLINICAL INVESTIGATION CONCLUSION ............................................................................... 44 
14.0 
PUBLICATION POLICY .............................................................................................................. 44 
15.0 
RISK ANALYSIS ......................................................................................................................... 44 
15.1 
Anticipated Clinical Benefits ..................................................................................................... 44 
15.2 
Foreseeable Adverse Events and Anticipated Adverse Device Effects .................................... 45 
15.3 
Residual Risks Associated with the Device Under Investigation, as Identified in the Risk 
Analysis Report .................................................................................................................................. 46 
15.4 
Risks Associated with Participation in this Clinical Investigation............................................... 46 
15.5 
Steps Taken to Control or Mitigate Risks ................................................................................. 46 
15.6 
Risk to Benefit Rationale .......................................................................................................... 47 
APPENDIX I: ABBREVIATIONS AND ACRONYMS .............................................................................. 48 
APPENDIX II: DEFINITIONS ................................................................................................................. 50 
APPENDIX III: SITE CONTACT INFORMATION ................................................................................... 53 

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Clinical Investigation Plan  
 
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APPENDIX IV: RATES OF FORESEEABLE ADVERSE EVENTS ......................................................... 54 
APPENDIX V: CASE REPORT FORMS ................................................................................................ 56 
APPENDIX VI: INFORMED CONSENT FORM ...................................................................................... 57 
APPENDIX VII: MONITORING PLAN .................................................................................................... 58 
APPENDIX VIII: REVISION HISTORY ................................................................................................... 59 
APPENDIX IX: CIP SUMMARY ............................................................................................................. 63 
APPENDIX X: REFERENCES ............................................................................................................... 66 
APPENDIX XI: PROCEDURAL STEPS ................................................................................................. 68 
 
 

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COMPLIANCE STATEMENT:  
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, the 
Declaration of Helsinki and the applicable regulatory requirements (such as, 21 CFR Part 50, 21 CFR 
Part 56,21 CFR Part 812, 21 CFR Part 54, and 21 CFR Part 11and 45 CFR part 46). The conduct of the 
clinical investigation will be approved by the Food and Drug Administration (FDA) and the appropriate 
Institutional Review Board (IRB) of the respective investigational site.  
 

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 Rationale for Conducting this Clinical Investigation 
FFR has been a useful tool to assess the functional severity of a stenotic lesion in a coronary artery and 
determine the need for revascularization in many clinical studies (1,2). FFR is the ratio between the 
pressure distal to the stenosis and the aortic pressure during hyperemia. The predominant advantage of 
percutaneous coronary intervention (PCI) guidance by coronary physiology is that FFR integrates 
variables such as luminal narrowing with myocardial perfusion area and collateral flow, leading to a more 
accurate assessment of myocardial ischemia than coronary angiography alone (1). It has been shown 
that coronary revascularization can be safely deferred if FFR is above the ischemic threshold of 0.80 
(2,3). 
The most recent ESC guidelines on myocardial revascularization recommend FFR with the highest 
degree (Class I, Level of Evidence A) to assess the hemodynamic relevance of intermediate-grade 
stenosis when evidence of ischemia is not available (4). Pre-PCI FFR has a Class IIa, Level of Evidence 
B recommendation in Canada, and the US (5). Despite all these recommendations, the adoption rate for 
FFR remains sub-par, partially due to the use of costly pressure wires and patients’ discomfort from the 
administration of hyperemic agents. 
These limitations of FFR may be overcome in part by image-based physiology assessment. For instance, 
the HeartFlow FFRCT applies computational fluid dynamic (CFD) simulation on CT angiography, which 
provides a non-invasive coronary fractional flow reserve measurement without a coronary pressure wire 
or hyperemic agent (6-8). CathWorks FFRangio is derived from routine coronary angiography creating a 
three-dimensional (3D) reconstruction of the coronary arterial system and estimating the resistance and 
flow across stenosis (9). 
However, FFRCT is limited to a small patient population, given the relatively low penetration of coronary 
CTA in the US. Additionally, CT imaging technology has significant limitations in the presence of calcified 
coronary arteries and prior metallic stents (10,11). Furthermore, despite being a non-invasive procedure, 
both FFRCT and FFRangio may not accurately provide enough detailed vascular morphology compared to 
intravascular images, which is essential to optimize PCI procedures.  
Optical Coherence Tomography (OCT) provides intravascular imaging with high-resolution (10-20 µm) 
cross-sectional images of plaque morphology, which allows optimizing stent placement and size and 
strut coverage (12). The results of a recent pilot study1 suggested that OCT can also be used to 
characterize the functional severity of the stenotic lesion via an image-based physiology assessment 
index called Virtual Flow Reserve (VFR). VFR is derived from a flow model based on three-dimensional 
lumen morphology of the OCT pullback images data to estimate the pre- and post-PCI coronary flow 
resistance. This technology has the potential to become an important stent planning tool that would be 
extremely useful to patients with complex lesions if it can be shown to correlate with computational FFR. 
The present VFR model utilizes a lumped parameter model for deriving the lesion associated physiology 
based on OCT pullback images. This image-based physiology assessment can not only evaluate the 
effect of lesion severity on coronary physiology while simultaneously evaluating the vascular/lesion 
 
1 Document 90465825 Virtual Flow Reserve Tech Report - Data on File at Abbott 

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Please refer to the Instructions for Use (IFU) for details of each respective system. 
  Indication for Use 
Virtual Flow Reserve (VFR) is a physiologic index for diagnosing the functional significance of coronary 
stenoses based on the vascular morphology information obtained through OCT image pullback. VFR 
analysis is intended to support the functional evaluation of coronary artery disease and procedural 
scenario planning. The results of VFR are intended to be used by qualified clinicians in conjunction with 
the clinical history and symptoms of patients as well as other diagnostic tests according to clinician’s 
professional judgment. 
 Description of the Device(s)  
OPTIS System: 
The ILUMIEN OPTIS™, OPTIS™ Integrated, and OPTIS™ Mobile systems with Dragonfly™ DUO or 
Dragonfly™ OPTIS™ or Dragonfly OpStarTM Imaging Catheter is intended for the imaging of coronary 
arteries and is indicated in patients who are candidates for transluminal interventional procedures. 
The OPTIS™ Systems will further acquire radio frequency signal outputs from both a distal intracoronary 
pressure transducer and a proximal aortic pressure transducer to determine the physiological 
parameters, FFR and RFR. The physician may use the FFR and resting full-cycle ratio (RFR) parameter 
data, along with knowledge of patient history, medical expertise and clinical judgment to determine if 
therapeutic intervention is indicated. 
Dragonfly: 
The Dragonfly Duo, Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter with the OCT Imaging 
System is intended for the imaging of coronary arteries and is indicated in patients who are candidates 
for transluminal interventional procedures. The Dragonfly Duo, Dragonfly OPTIS or Dragonfly OpStar 
Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter.  The Dragonfly Duo, Dragonfly 
OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in 
a target vessel which has undergone a previous bypass procedure. 
PressureWire X:  
PressureWire™ is designed to be used as a regular guidewire to direct a catheter through the blood 
vessel and to be used to measure intra-arterial pressures. The PressureWire devices consist of a 0.014” 
guidewire, a torque device, and a cable hookup, for PressureWire X (cable version), or wireless 
transmitter, for PressureWire X (wireless version). The guidewire has an integrated sensor chip element 
located 30 mm from the distal tip to enable measurements of physiological parameters such as pressure. 
Wireless PressureWire devices are all available in two different lengths, 175 cm and 300 cm. Each 
PressureWire X (wireless) guidewire is uniquely paired with a transmitter which sends data to a receiver 
using wireless technology. 
PressureWire devices are used primarily for measurement of FFR and RFR. FFR is the ratio between 
the maximum flow distal to a stenosis and the normal maximum flow in the same vessel, calculated by 

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FFR = Pd/Pa where Pd is the pressure distal to the stenosis and Pa is the aortic pressure. While FFR is 
measured during hyperemia, RFR measures Pd and Pa over the entire cardiac cycle at rest (sampled at 
100 Hz) and uses a moving average filter to determine the minimum value of the Pd/Pa ratio, which is 
then averaged over multiple cardiac cycles to obtain the resting index. In case of multiple sequential 
stenoses or diffuse lesions, RFR pullback pressure assessment can identify multiple lesions with 
functional significance. 
The indications for PressureWire in all geographies can be found in the instructions for use (IFU) 
provided with the product or on the eIFU.abbottvascular.com website. 
Please refer to the IFU for additional information regarding the device used in this clinical investigation. 
 Summary of Preclinical Studies 
A summary of VFR theoretical backgrounds is provided in Document 90465825 Virtual Flow Reserve 
Tech Report1
3.0 
CLINICAL INVESTIGATION DESIGN 
This study is a single-arm, prospective, multi-center study collecting OCT pullback images of lesions pre-
PCI and (optional) post-PCI procedure, and the corresponding pressure tracings and physiology indices. 
No investigational device will be used in this study. VFR will be calculated offline using the OCT pullback 
images. Up to 30 centers in the US will enroll approximately 310 patients. There will be no clinical follow-
up after completion of the PCI procedure. The expected duration of enrollment is approximately 15 
months. The total duration of the clinical investigation is expected to be approximately 27 months. 
3.1 
Clinical Investigation Procedures Schedule 
Subjects will be considered enrolled in this clinical investigation when all of the following criteria are met: 
Informed Consent Form (ICF) is signed, they meet all eligibility criteria and have undergone physiological 
indices measurement and OCT pullbacks. Enrolled subjects must follow all CIP requirements. 
Data will be collected at baseline, during procedure, and post-procedure. There is no clinical follow-up in 
this study. The flowchart of the process is shown in Figure 2 below. 
 
1Document 90465825 Virtual Flow Reserve Tech Report - Data on File at Abbott 

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To ensure timely feedback on the quality of OCT pullbacks and pressure tracings, as well as a balanced 
baseline FFR distribution in line with study assumptions, the core lab will send data quality and baseline 
FFR data to Abbott (group 2) for 
enrolled subjects (Figure 3). Based on this information, Abbott 
may choose to work with the sites on improving data quality as well as rebalancing the FFR distributions 
via encouraging or capping enrollment in certain subgroup(s). If the enrollment cap is implemented, 
protocol deviation(s) will be given if the sites do not follow the capping criteria.   
3.3 
Suspension or Early Termination of the Clinical Investigation 
While no formal statistical rule for early termination of the clinical investigation for insufficient 
effectiveness of the device under investigation is defined, the Sponsor reserves the right to discontinue 
the clinical investigation at any stage or reduce the follow-up period with suitable written notice to the 
investigator. Possible reason(s) may include, but are not limited to: 
• 
An oversight committee (e.g., Steering Committee) makes a recommendation to stop or terminate 
the clinical investigation (such as higher frequency of anticipated adverse device effects) 
 
Should the clinical investigation be discontinued by the Sponsor, subjects will be followed per routine 
hospital practice with device-related AEs reported to the Sponsor as per vigilance/commercial reporting 
requirements. The investigator shall provide a written statement to the IRB. All applicable clinical 
investigation documents shall be subject to the same retention policy as detailed in Section 11.5 of the 
CIP.  
 
A Principal Investigator, IRB or regulatory authority may suspend or prematurely terminate participation 
in the clinical investigation at the investigational site(s) for which they are responsible. The investigators 
will follow the requirements specified in the Clinical Trial Agreement.  
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual site in the 
interest of safety, the Sponsor will inform all other Principal Investigators. 
4.0 
ENDPOINTS 
There are two co-primary endpoints and multiple secondary endpoints in this clinical investigation. 
4.1 
Co-Primary Endpoints and Rationale  
The co-primary endpoints of the study will be the sensitivity and specificity of VFR against FFR, each of 
which will be tested against a prespecified performance goal. 
4.2 
Secondary Endpoints 
Secondary endpoints will be descriptive and will include the overall diagnostic accuracy, positive 
predictive value (PPV) and negative predictive value (NPV), the correlation between VFR and FFR, and 
the area under curve (AUC) against FFR. 

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5.0 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 
Subject Population 
This clinical investigation will enroll male and female subjects from the general interventional cardiology 
population. Subjects must meet all eligibility criteria and provide written informed consent prior to 
conducting any investigation-specific procedures not considered standard of care.  
5.2 
Subject Screening and Informed Consent 
 Subject Screening 
Potential patients presenting at the clinical sites will be fully informed about the clinical investigation, 
following the established Informed Consent process (described in Section 5.2.2). Once a duly dated and 
signed Informed Consent form is obtained, the clinical investigation-specific screening procedures may 
begin.  
The following assessments are performed as part of the screening process: 
• 
Clinical indication for angiography with potential for PCI 
• 
Inclusion and exclusion criteria 
 
Subjects must be screened for clinical investigation eligibility by a member of the site’s clinical 
investigation team previously trained to the CIP, and if applicable will be entered into a site-specific 
screening log. 
 
In case the subject does not meet all inclusion criteria or meets any of the exclusion criteria, the subject 
is considered a screening failure. The Principal Investigator or the delegated clinical investigation 
personnel will record the screening failure in the hospital records. 
 
Subjects who signed an Informed Consent form and met general inclusion criteria and no exclusion 
criteria will participate in the clinical investigation. These patients will also be recorded in the hospital 
records. 
 
Subject data will be collected following enrollment into the clinical investigation described in Section 5.4.  
 Informed Consent 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s IRB. This process will include a verbal 
discussion with the subject on all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate, such as details of clinical investigation procedures, anticipated benefits, and 
potential risks of clinical investigation participation. Subjects must be informed about their right to 
withdraw from the clinical investigation at any time and for any reason without sanction, penalty or loss of 
benefits to which the subject is otherwise entitled. Withdrawal from the clinical investigation will not 
jeopardize their future medical care or relationship with the investigator.  
 

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During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper 
influence on the subject and will respect subject’s legal rights. Financial incentives will not be given to the 
subject. Subjects may be compensated for time and travel directly related to the participation in the 
clinical investigation, if applicable per the Clinical Trial Agreement. The subject shall be provided with the 
Informed Consent form written in a language that is understandable to the subject and has been 
approved by the center’s IRB. The subject shall have adequate time to review, ask questions, and 
consider participation. The Principal Investigator or his/her authorized designee will make efforts to 
ensure that the subject understands the information provided. If the subject agrees to participate, the 
Informed Consent form must be signed and dated by the subject and thereafter by the person obtaining 
the consent prior to any clinical investigation-specific procedures. The signed original will be filed in the 
subject’s hospital or research charts, and a copy will be provided to the subject. 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment should be 
reported to Sponsor within 5 working days and to the reviewing center’s IRB according to the IRB’s 
reporting requirements. 
 
If, during the clinical investigation, new information becomes available that can significantly affect a 
subject's future health and medical care, the Principal Investigator or his/her authorized designee (if 
applicable) will provide this information to the subject. If relevant, the subject will be asked to confirm 
their continuing informed consent in writing. Enrollment does not occur at the time of signing informed 
consent.  
5.2.2.1 Special Circumstances for Informed Consent  
Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals 
without legal authority, are excluded from the study population. 
The legally acceptable representative will represent the individual during the Informed Consent process, 
which will be performed according to the requirements in Section 5.2.2. The individual will also be 
informed about the clinical investigation within his/her ability to understand. The explicit wish of the 
individual to decline participation or withdraw from the clinical investigation at any time will be respected. 
Individuals under the age of 18 or age of legal consent are excluded from the study population. 
Individuals unable to read or write may be enrolled in this clinical investigation. Informed consent will be 
obtained through a supervised oral process. An independent witness will be present throughout the 
Informed Consent process. The written Informed Consent form and any other information will be read 
aloud and explained to the prospective subject or his/her legally acceptable representative (LAR) and 
either the subject or LAR will sign and personally date the Informed Consent form. The witness will also 
sign and personally date the Informed Consent form attesting that the information was accurately 
explained, and that informed consent was freely given. 
 
Pregnant or breastfeeding women are excluded from the study population. 
 
All other aspects of the Informed Consent process will be in compliance with Section 5.2.2. 

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In addition, an authorization for use and disclosure of the subject’s protected health information, in 
accordance with the Health Insurance Portability and Accountability Act (HIPAA), must be obtained from 
the subject or their legally acceptable representative.  
For live cases at congresses, the patients need to sign a specific Live Case ICF, approved by the IRB. 
The investigator must notify the Sponsor prior to performing a live case. 
5.3 
Eligibility Criteria 
 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a 
candidate patient. If some of the clinical and laboratory tests are not included in site standard tests, they 
must be done after written informed consent is obtained. Subjects must meet ALL of the inclusion criteria 
to be considered for the clinical investigation. If ANY of the exclusion criteria are met, the patient is 
excluded from the clinical investigation and cannot be enrolled. There is no limit on the number of 
vessels per patient if the vessels met all inclusion and exclusion criteria. 
 Inclusion Criteria 
1. Age ≥18 years 
2. Patient provides written informed consent 
3. Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic 
assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-
90%), if clinically indicated  
4. Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) [200 μg for 
the left and or 100 μg for the right coronary artery] or 140 μg/kg/min for intravenous (IV)) used 
as hyperemic stimulus 
5. Clinical presentation with or history of stable angina, unstable angina, or silent ischemia 
(defined as abnormal stress test or abnormal invasive physiology assessment) that has led to 
the procedure 
 General Exclusion Criteria 
1. Prior history of myocardial infarction (MI) in the target vessel     
2. Presence of acute ST Elevation Myocardial Infarction (STEMI) 
3. Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI) 
4. TIMI flow < Grade 3 at baseline or visible thrombus 
5. Prior history of coronary artery bypass grafting (CABG) 
6. Prior heart transplant 
7. Severe valvular heart disease or history of valve repair or replacement 
8. Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis 
9. Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a 
CTO (chronic total occlusion) 
10. CTO in the target vessel 
11. Severe diffuse disease observed in target vessel defined as the presence of diffuse, serial 

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gross luminal irregularities present in the majority of the coronary tree 
12. Presence of any myocardial bridge (MB), regardless of vessel location   
13. Contraindication for FFR examination or administration of vasodilators 
14. Known LVEF ≤45%  
15. Target lesion involves Left Main coronary artery or ostial right coronary artery 
16. Known renal insufficiency (eGFR < 30 ml/kg/m2 or serum creatinine ≥ 2.5 mg/dL) unless patient 
is on dialysis 
17. Heart Failure NYHA Class III or IV 
18. Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be 
performed within 14 days (≤14 days) prior to the index procedure per site standard test) 
19. Subject has or had active COVID-19 symptoms and/or a positive test result within the prior 2 
months 
20. Participation in another clinical study of an investigational drug or device 
21. Presence of aneurysm in the target vessel   
 Imaging and Pressure Tracing Exclusion Criteria 
1. Artifact in pre-PCI OCT for the target lesion or in the event of multiple target lesions, artifact in 
pre-PCI OCT for ALL target lesions   
2. Target lesion requires any preparation (including but not limited to balloon dilatation, 
atherectomy, etc.) prior to pre-PCI OCT and physiology measurements, or in case of multiple 
target lesions, ALL target lesions require any preparation (including but not limited to balloon 
dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement 
3. Severe vessel tortuosity or calcification in the target vessel such that it is unlikely that the OCT 
catheter can be delivered 
4. Target lesion not imaged by OCT or in the event of multiple target lesions, ALL target lesions 
not imaged by OCT 
5. Pressure drift of > 0.03; i.e. Pd and Pa ratio value < 0.97 or > 1.03, unless physiology 
measurements are repeated after re-equalization  
6. Target lesion or significant CAD beyond 60 mm from coronary ostium; i.e. not able to clearly 
image and capture all disease segment with OCT in 1 run 
7. Incorrectly done or unsuccessful catheter purge and/or contrast flush  
8. Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter 
stenosis ≥ 40%) 
9. Inability to receive intracoronary nitroglycerin prior to OCT or FFR 
10. Use of flush media other than radiographic contrast 
5.4 
Subject Enrollment 
Subjects are considered enrolled in this clinical investigation after signing the ICF, met all inclusion 
criteria and has undergone physiological indices measurement and OCT pullbacks. If ANY of the 
exclusion criteria are met, the patient is excluded from the clinical investigation and cannot be enrolled. 
If subjects are enrolled into the clinical investigation and are later found to have met exclusion criteria or 
not all inclusion criteria, these subjects will be included in the analysis population and must follow all the 

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CIP requirements. Enrolled subjects may be excluded from the analysis population due to the quality 
check by core laboratory based on OCT pullback and pressure tracing data. 
 Enrollment of Medicare Beneficiaries  
This clinical investigation will enroll Medicare beneficiaries and therefore conforms to all standards of 
Medicare coverage requirements. The Risks and Benefits section describes how all enrolled subjects, 
including Medicare beneficiaries, may be affected by the device under investigation. 
Subjects enrolled in the clinical investigation are expected to be consistent with the Medicare population 
based on age and as such, the clinical investigation results are expected to be generalizable to the 
Medicare population. 
 Historically Under-Represented Demographic Subgroups 
The Sponsor intends to implement FDA's guidance on sex-specific data in medical device clinical 
investigations to ensure adequate representation of women and other traditionally under-represented 
demographic subgroups in this clinical investigation. As noted in the guidance, some barriers to 
participation of women and ethnic minorities in clinical investigations have traditionally been: 
• 
Lack of understanding about main obstacles to participation of such subgroups in clinical 
research  
• 
Inclusion/exclusion criteria potentially not needed to define the clinical investigation population 
may unintentionally exclude specific subgroups  
• 
Under diagnosis of disease etiologies and pathophysiology leading to under referral of 
demographic subgroups  
• 
Avoidance of specific subgroups by investigators and Sponsors due to the perception that it takes 
more time and resources to recruit them  
• 
Fear of fetal consequences (for female participants)  
• 
Family responsibilities limiting women's ability to commit time for follow-up requirements 
The Sponsor will take the following steps to ensure adequate representation of women and racial or 
ethnic minorities in this clinical investigation:  
• 
The Sponsor will provide training to investigational site personnel to ensure adequate 
representation of these demographic subgroups  
• 
The Sponsor will approach sites without bias or consideration for specific demographic subgroups  
5.5 
Subject Discontinuation 
Each enrolled subject shall remain in the clinical investigation until completion of index procedure; 
however, a subject’s participation in any clinical investigation is voluntary and the subject has the right to 
withdraw at any time without penalty or loss of benefit. Conceivable reasons for discontinuation may 
include, but not be limited to, the following: 

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• 
Subject death 
• 
Subject voluntary withdrawal  
• 
Subject withdrawn by the Investigator 
 
The Sponsor must be notified of the reason(s) for subject discontinuation. The site will provide this 
information to the Sponsor. Investigators must also report this to their respective IRB as defined by their 
institution’s procedure(s).  
5.6 
Number of Subjects  
The clinical investigation will enroll approximately 310 subjects. 
5.7 
Total Expected Duration of the Clinical Investigation 
The total duration for the clinical investigation, including subject recruitment, data collection and clinical 
investigation closure, is expected to be up to 27 months. 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS 
6.1 
Baseline/Pre-procedure/Pre-treatment 
The site Principal Investigator is responsible for ensuring all clinical investigation data is collected as 
required per CIP scheduled procedures. 
 Baseline Assessments 
All baseline tests will be done within 30 days prior to the index procedure, unless otherwise specified by 
the protocol. 
• 
Demographics: include subject’s age and sex 
• 
Cardiovascular history (most recent values closest to baseline visit) 
• 
Medical history: indicate subject’s risk factors, relevant co-morbidities, previous cardiac 
procedures 
• 
Medication (only chronic medication): indicate the drug category the subject is currently taking on 
a long-term basis, i.e. no short-term medication 
• 
Serum creatinine, hematocrit, and hemoglobin measured  
• 
LVEF assessment (if no LVEF test result within 3 months is available).  Assessment can be by 
echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), 
ventriculography (LV gram) or other method 
• 
CHF assessment (NYHA class) 
• 
Physical examination: include subject’s height, weight (measurements taken during visit) 
• 
12-lead ECG  
• 
Negative pregnancy test is required for any female of childbearing potential within 14 days prior to 
index procedure 

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• 
Angiogram Imaging - Diameter Stenosis (%) 
 Baseline and Post-PCI Imaging Assessments  
Coronary angiography is an invasive test where radiopaque dye is injected through a catheter into the 
coronary arteries to assess severity of narrowing(s) from coronary artery disease. 
Following administration of at least 100 µg IC nitroglycerin, angiography of the lesion should be 
performed in at least 2 contralateral views without panning for both baseline and (optional) post-PCI. 
 Pre-procedure CIP-Required Medications  
Patients shall receive medication prior and post-PCI per standard of care.  
6.2 
PCI Procedure 
The following is a description of the image acquisition and treatment steps to be used during the index 
procedure. The pre-PCI procedures should be conducted in the following order: Pd/Pa and RFR 
snapshot measurement, FFR measurement, dedicated period for resolution of hyperemia, RFR pullback 
measurement, drift check, and OCT imaging procedure. The optional post-PCI step should include final 
OCT imaging procedure, followed by physiological measurements (refer to the flowchart in Figure 2). 
Post-PCI study data collection step is optional but strongly recommended if PCI is performed.  
All OCT data and physiological indices measurements will be stored digitally for subsequent analysis and 
these images must be sent to the Core Laboratory for quality check. 
Any vessel preparation (if necessary) with balloon dilation or atherectomy should be performed only after 
pre-PCI physiological indices measurement and OCT have been performed.  
If applicable, PCI will be performed according to local standard practice. PCI information will be collected 
on the appropriate eCRF. For each treated lesion, the guiding catheter size, the total number of stents 
used, and the relevant stent information (diameter and length) must be recorded on the appropriate 
eCRF. Any vessel preparation step including, pre-dilation, post-dilation, or atherectomy device use must 
also be recorded. If the subject undergoes atherectomy during PCI, post-PCI OCT and physiological 
steps are not needed and that is the end of the protocol for the subject. 
 Physiological indices measurement procedures  
In all cases, physiological indices measurement must be performed. Any standard guidewire must be 
removed completely from target vessel prior to any physiological measurement. 
At least 100 µg IC nitroglycerin must be administered prior to physiological assessment. The preparation 
and use of the PressureWire will be according to its respective IFU. The aortic pressure transducer and 
PressureWire must both be equilibrated to zero pressure outside of the body. The PressureWire is then 
advanced to the aorto-ostial junction where PressureWire equalization is performed after ensuring the 
presence of an appropriate aortic waveform (distinct dicrotic notch), with guide disengagement 
performed, if necessary. PressureWire is then advanced across the lesions with the sensor positioned 
into the distal coronary artery and at least 10 mm distal to the most distal target lesion. The PressureWire 
position is then captured via cine documentation with contrast administration (this may be successfully 

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achieved by capturing the image during saline flush of residual contrast within the guiding catheter), and 
baseline pressures documented prior to inducing hyperemia following confirmation of an appropriate 
aortic waveform (distinct dicrotic notch), with guide disengagement, if necessary. Pre-PCI and (optional) 
post-PCI Pd/Pa and RFR snapshot values and tracings will be collected. 
For FFR measurement, maximal hyperemia is induced per standard practice (140 μg/kg/min IV or high 
dose 200 μg or 100 μg for the left or right coronary artery IC adenosine, respectively) and recorded until 
a stable minimum FFR reading has been achieved. FFR values and tracings, will be recorded and 
captured for both pre-and (optional) post-PCI. 
Following successful Pd/Pa, RFR, and FFR measurements and once resting conditions have been re-
established (minimum wait 1 minute after IC administration and 3 minutes following IV administration), a 
slow and measured RFR pullback is conducted both pre-PCI and (optional) post-PCI. At the end of the 
both pre-PCI and (optional) post-PCI RFR pullback, a drift check should be performed, and a snapshot of 
the end value of Pd/Pa in FFR mode needs to be recorded. 
 OCT procedures  
The preparation and use of the OCT catheter will be according to its respective IFU. For all indicated 
vessels, if less than 10 minutes have passed since the last dose of IC nitroglycerine, no extra dose is 
needed. If more than 10 minutes have passed since the last dose of IC nitroglycerine, at least 100 µg IC 
nitroglycerin should be re-administered before OCT pullbacks. The proximal and distal reference 
segments are initially identified by angiography. The proximal and distal reference diameters should be 
recorded on the eCRF. OCT Imaging must be performed using the pullback device at 75 mm pullback 
(survey mode), 5 frames per mm over 2.1 seconds. The OCT catheter should be placed at the location 
where the imaging lens is at the same location as the PressureWire sensor and would reach the guide 
catheter at the end of the imaging run as well as at least 10 mm distal to the distal end of the lesion, with 
the aim of imaging as much of the coronary artery as possible. All significant lesions in a vessel need to 
be within a single OCT pullback. OCT pullback image will be qualified as long as all disease segment 
was captured. The lens position should be captured via cine documentation prior to each pullback. For 
standard pullback, the recommended contrast injection volume is 14 ml at an injection rate of 4 mL/s in 
the left coronary artery and 12 mL at an injection rate of 3 mL/s in the right coronary artery. Cine 
angiography with contrast opacification of the coronary artery in the desired angiographic co-registration 
view(s) must be performed during the pre- and (optional) post-PCI OCT pullback without panning. 
Contrast volume and method are collected on the eCRF.  
For cases with PCI, the post-PCI study data collection step is optional. If a post-PCI study data collection 
was performed, both intermediate and final OCT pullbacks should be collected after OCT-guided stent 
optimization was done, and the post-PCI physiological assessment must be performed after the final 
OCT run.  Pre-PCI, (optional) intermediate post-PCI, and (optional) final post-PCI OCT pullback images 
need to be uploaded to the OCT Core Laboratory via BioClinica website. 
 Multiple target lesions/vessels treatment 
Subjects requiring multi-vessel PCI may be enrolled in this trial. There is no limit on the number of target 
lesions per epicardial vessel and target vessels per patient in this study. All target lesions and vessels 
must satisfy all inclusion and exclusion criteria. 

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 Non-target lesion/vessel treatment 
Non-target lesion/vessel treatment (i.e., lesion/vessel that does not meet the inclusion/exclusion criteria) 
are not allowed prior to or during the study-required procedure. They may be treated either after the 
study-required procedure is completed within the same PCI procedure or as a staged procedure. In 
either case, the study participation will end at the completion of the study-required procedure (during the 
index procedure). 
 Staged procedure considerations  
All aspects of the study protocol must occur during one procedure, which is considered the study index 
procedure. This may be a planned staged procedure based on a diagnostic catheterization (pre-or post-
consent). Subject participation begins at the index procedure upon study device insertion in enrolled 
subjects. The enrollment is based on subjects satisfying all eligibility criteria and had a successful pre-
PCI physiological indices measurement and OCT imaging conducted on the qualified lesion(s)/vessel(s). 
Subject participation ends at the conclusion of the study index procedure with or without PCI performed. 
There will be no data collection from any additional staged procedure as subject participation ends at the 
conclusion of the study index procedure and the subject cannot be re-enrolled in the study.    
 Bifurcation lesions consideration  
Bifurcation lesions consideration is shown in Figure 4. 
• 
Scenario 1: For the main branch lesion with a side branch that has a minimal disease which is 
defined as <40% diameter stenosis by visual estimate), the main branch lesion can be enrolled 
as the target lesion. Treatment of the side branch is optional and outside of the study protocol.  
 
• 
Scenarios 2 and 3: If the side branch vessel has significant ostial disease with a planned single 
(Scenario 2) or two-stent (Scenario 3) strategy, only the main vessel can be enrolled into the 
study, following the FUSION workflow in the main branch. For two-stent strategy, this will count 
as one lesion and physiology measurement and OCT imaging are not required in the side branch. 
Treatment of the side branch will be outside of the study protocol. 
 
• 
Scenario 4: For the main branch and side branch lesions that are both to be considered as target 
lesions, these two lesions need to be distant from each other (i.e., side branch lesion is not ostial) 
treated independently and both branches are of adequate size to undergo physiology and OCT 
measurements. In that setting, the main and the side branch are considered separate target 
vessels and all physiology and OCT. The measurements of both physiology and OCT must be 
done in the respective target vessel separately. i.e., in the side branch for the side branch lesion 
assessment. Of note, while assessing side branch lesions, upstream lesions in the main branch 
must also be imaged.  

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6.3 
Post–PCI (In-hospital) 
The timing and method of vascular sheath removal, as well as timing of ambulation, use of post-
procedural medications and discharge is per standard of care. Study participation ends when the subject 
leaves the catheterization laboratory. 
6.4 
Follow-up Assessments  
No follow-up will be required in this study.   
6.5 
Additional Information on Required Assessments 
Physical Examination 
Physical examination will be completed and recorded at baseline. Any clinically significant findings during 
the physical examination should be reviewed by the investigator. Any clinically significant findings during 
the baseline physical examination should be reported in the subject medical history. Any clinically 
significant findings during physical examinations post-device insertion should be reported as adverse 
events. Physical examinations should be performed per the standard of care and may be completed by 
any qualified medical personnel.  
 
 

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6.6 
Physiology and OCT Core Laboratories 
This clinical investigation will utilize an independent core laboratory for the assessment and evaluation of 
all pre-and post-PCI OCT pullback images and corresponding pressure recordings required during the 
clinical investigation period. 
All clinical investigation-required pre-and post-PCI OCT pullback images and corresponding pressure 
recordings should be submitted to the core laboratories by uploading the assessments directly to the 
core laboratory’s database. The core laboratory will review and provide quality check of all pullback 
images and pressure tracings. 
The core laboratory will review co-registered angiography and OCT pullbacks, and exclude cases with 
spastic artery, myocardial bridge and accordion effect. After successful auto-calibration of OCT pullback, 
the core laboratory will exclude cases with low image quality caused by significant blood in lumen or 
catheter purge issue as well as cases that present with OCT artifact. The core laboratory will reject 
pullback with the presence of ruptured plaques, hematoma, thrombus or old stent. 
Pressure tracings will also be reviewed for pressure drift and significant artifacts per the core laboratory’s 
standard operational procedure, and reasons of rejection for each unacceptable pressure tracing will be 
documented by the core laboratory.  
All the remaining acceptable OCT pullback images and pressure tracings will be used for endpoint 
analysis. VFR computed using Abbott validated software will be validated against the core lab reported 
FFR.    
7.0 
ADVERSE EVENTS 
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
7.1 
Definition 
 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the medical device under investigation. 
 
Note 1: This definition includes events related to the medical device under investigation or the 
comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices under 
investigation. 

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 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function. 
5. chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a 
serious deterioration in health, is not considered to be an SAE. 
 Device Deficiency/Device Malfunction  
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate 
labeling. This includes the failure of the device to meet its performance specifications or otherwise 
perform as intended. Note: Performance specifications include all claims made in the labeling of the 
device. 
A device malfunction is the failure of a device to meet its performance specifications or otherwise 
perform as intended, when used in accordance with the instructions for use or CIP. 
7.2 
Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product or device under 
investigation caused or contributed to an AE is to be determined by the Investigator and recorded on 
the appropriate CRF form. Determination should be based on assessment of temporal relationships, 
evidence of alternative etiology, medical/biologic plausibility, and patient condition (pre-existing 
condition). 
7.3 
Adverse Event and Device Deficiency/Device Malfunction Reporting 
 Adverse Event Reporting 
General AE Reporting 
Safety surveillance and reporting will be done only for enrolled subjects, and it starts when the study 
device is introduced into the subject’s vasculature. Safety surveillance and reporting will continue through 

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the procedure and end when the subject has left the procedure room, the subject is deceased, the 
subject concludes participation in the clinical investigation, or the subject withdraws from the clinical 
investigation, whichever occurs first. Adverse events will not be collected for screen failure subjects. All 
adverse event data, including deaths and device deficiency data (if applicable), will be collected 
throughout the time period defined above and will be reported to the Sponsor on a CRF. Additional 
information with regard to an adverse event should be updated within the appropriate CRF.  
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
 
An offline form will be made available to allow the investigator to report SAEs in the event the entry 
cannot be made in the EDC. This does not replace the EDC reporting system. All information must still 
be entered in the EDC system as soon as feasible. 
 
Non-cardiac related abnormal laboratory values will not be considered AEs unless:  
1. the investigator determined that the value is clinically significant,  
2. the abnormal lab value required intervention, or  
3. the abnormal lab value required subject withdrawal from the clinical investigation. 
All adverse events will be collected on each subject through the end of the procedure. 
SAE Reporting 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than outlined 
below.  
Clinical Site 
Reporting timelines 
All Sites 
SAEs must be reported to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those outlined. 
The date the site staff became aware the event met the criteria of an SAE must be recorded in the 
source document.  The Investigator will further report the SAE to the local IRB/EC according to the 
institution’s IRB/EC reporting requirements. 
 Device Deficiency/Malfunction Reporting 
All device deficiencies/malfunctions should be reported on the appropriate CRF form.  
The investigator should report all device deficiencies/malfunctions to the Sponsor as soon as possible 
but no later than outlined below.  
Clinical Sites 
Reporting timelines 

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All Sites 
Device deficiencies/malfunctions must be reported to the Sponsor no later 
than 3 calendar days from the day the site personnel became aware of the 
event or as per the investigative site’s local requirements, if the requirement 
is more stringent than those outlined. 
 
The device should be returned to the Sponsor.   
 
Device deficiencies/malfunctions should be reported to the IRB per the investigative site’s local 
requirements. 
An offline form will be made available to allow the investigator to report device deficiencies/malfunctions 
in the event that the entry cannot be made in the EDC system. This does not replace the EDC reporting 
system. All information must still be entered in the EDC system as soon as feasible.  
 
In case a device deficiency/malfunction occurred before the patient ID has been assigned, the device 
deficiency should be reported to the Sponsor via the offline reporting form. 
 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report SAEs and reportable device deficiencies/malfunctions to the country regulatory 
authority, per local requirements.  
 
Note: Reportable device deficiencies/malfunctions include device deficiencies/malfunctions that might 
have led to an SAE if a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate. These are handled under the SAE reporting system. 
8.0 
STATISTICAL CONSIDERATIONS 
The following section describes the statistical methods for the clinical investigation. Additional details on 
statistical analyses, including justification of clinical investigation design, sensitivity analyses, poolability 
analyses, subgroup analyses and analysis of descriptive endpoints, may be maintained in a separate 
Statistical Analysis Plan (SAP). 
8.1 
Analysis Populations 
The primary analysis population will include all subjects who have signed informed consent, met all 
inclusion and exclusion criteria, and have acceptable OCT pullbacks and pressure tracings for computing 
both the VFR and FFR indices  
8.2 
Statistical Analyses  
 Primary Endpoint(s) Analyses 
The co-primary endpoints of the study will be the sensitivity and specificity of VFR against FFR, each of 
which will be tested against a prespecified performance goal.  

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𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂 𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷 𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴=  
𝑇𝑇𝑇𝑇+ 𝑇𝑇𝑇𝑇
𝑇𝑇𝑇𝑇+ 𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹+ 𝐹𝐹𝐹𝐹 
Where TP denotes the number of True Positives, FN denotes the number of False Negatives, TN 
denotes the number of True Negatives, and FN denotes the number of False Negatives. 
The point estimate and 95% confidence interval for this statistic will be reported. 
8.2.2.2 Secondary Endpoint #2: Positive predictive value (PPV) 
PPV will be estimated using the 2×2 contingency table comparing VFR and FFR measurements. PPV is 
defined as the proportion of lesions with the disease and with a positive test result among the group of 
lesions with a positive test result(13), which can be expressed in the following way using the definition: 
𝑃𝑃𝑃𝑃𝑃𝑃=  
𝑇𝑇𝑇𝑇
𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹 
Where TP denotes the number of True Positives and FP denotes the number of False Positives.  
The point estimate and 95% confidence interval for this statistic will be reported. 
8.2.2.3 Secondary Endpoint #3: Negative predictive value (NPV) 
NPV will be estimated using the 2×2 contingency table comparing VFR and FFR measurements. NPV is 
defined as the proportion of lesions without the disease and with a negative test result among the group 
of lesions with negative test results(13), which can be expressed in the following way using the definition: 
𝑁𝑁𝑁𝑁𝑁𝑁= 
𝑇𝑇𝑇𝑇
𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹 
Where TN denotes the number of True Negatives and FN denotes the number of False Negatives.  
The point estimate and 95% confidence interval for this statistic will be reported. 
8.2.2.4 Secondary Endpoint #4: Correlation between VFR and FFR 
The correlation between VFR and FFR will be estimated as the R2 correlation coefficient from the simple 
linear regression model using VFR value as the independent variable and FFR as the dependent 
variable. The point estimate and 95% confidence interval for this statistic will be reported. 
8.2.2.5 Secondary Endpoint #5: Area under curve (AUC) against FFR 
AUC will be estimated as the area under the ROC curve. To construct a ROC curve, we plot 1-specificity 
on the x-axis and sensitivity on the y-axis (13) . Sensitivity and specificity are calculated at various values 
of VFR and FFR, and the AUC curve will be drawn using logistic regression.   The point estimate and 
95% confidence interval for this statistic will be reported.  

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8.4 
Timing of Analysis 
The primary endpoint analysis will be conducted after 310 subjects have undergone a procedure and 
usable VFR and FFR readings have been obtained. 
8.5 
Subgroup Analysis 
Subgroups to be analyzed will be outlined in the SAP. 
8.6 
Multiplicity 
Since the endpoints are co-primary and both must be passed to declare study success, there is no need 
for multiple comparison adjustment. 
8.7 
Pooling Strategy  
All pullback images and pressure tracings from different sites will be pooled for this validation study. 
Details of the pooling strategy will be described in the SAP 
8.8 
Procedures for Accounting for Missing Data 
Details regarding the treatment of missing, unused, or spurious data, including missing data due to 
subject drop-out, early withdrawal, exclusion of particular information from the testing of the hypothesis, 
and lost-to-follow-up may be provided in the SAP. 
8.9 
Planned Interim Analysis 
No interim analysis is planned for this study. 
8.10 Statistical Criteria for Termination 
There are no statistical criteria for termination of this clinical investigation. 
8.11 Success Criteria 
The clinical investigation will be deemed a success if both primary endpoint hypotheses are rejected at 
the 0.025 level. 
8.12 Deviations from Statistical Plan 
Any major changes to the statistical plan will be documented in an amendment to the statistical plan. 
Less significant changes to the planned analyses will be documented in the final report.   

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9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution will permit direct access to source data/documents for the purpose of 
performing clinical investigation-related monitoring, audits, IRB/EC review and regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow clinical investigation monitors or regulatory 
authorities including foreign countries to review, in confidence, any records identifying the subjects in this 
clinical investigation. This information may be shared with regulatory agencies; however, Sponsor 
undertakes not to otherwise release the subject's personal and private information. 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the clinical 
investigation. Sites will be selected based upon review of a recent site assessment, if applicable, and the 
qualifications of the investigators who will participate in the clinical investigation. 
10.2 Clinical Investigation Finances and Agreements 
The clinical investigation will be financed by Abbott.  Investigational sites will be compensated by Abbott 
for participation in the clinical investigation per the conditions of agreement between the Sponsor and the 
Investigational site. 
10.3 CIP Amendments  
Approved CIP amendments will be provided to the Investigators by the Sponsor prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the IRB/EC or equivalent committee of 
the CIP amendment (administrative changes) or obtaining IRB’s/EC’s approval of the CIP amendment 
(changes in subject care or safety), according to the instructions provided by the Sponsor with the CIP 
amendment.   
 
Acknowledgement/approval by the IRB of the CIP amendment must be documented in writing prior to 
implementation of the CIP amendment. Copies of this documentation must also be provided to the 
Sponsor. 
10.4 Training 
 Site Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training sessions, 
which may be conducted at an Investigator's meeting, a site initiation visit, or other appropriate training 
sessions. Over-the-phone or self-training may take place as required. Training of Investigators and 
clinical investigation personnel will include, but is not limited to, the CIP requirements, device usage, 
electronic case report form completion and clinical investigation personnel responsibilities. All 

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Investigators and clinical investigation personnel that are trained must sign a training log (or an 
equivalent) upon completion of the training. Prior to signing the training log, Investigators and clinical 
investigation personnel must not perform any CIP-related activities that are not considered standard of 
care at the site.  
10.5 Monitoring  
Sponsor and/or designee will monitor the clinical investigation over its duration according to the CIP-
specific monitoring plan which will include the planned extent of source data verification.  
 
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following criteria 
are met:  
 
• 
The investigator understands and accepts the obligation to conduct the clinical investigation 
according to the CIP and applicable regulations, and has signed the Investigator Agreement   
• 
The Investigator and his/her staff should have sufficient time and facilities to conduct the clinical 
investigation and should have access to an adequate number of appropriate subjects to conduct 
the clinical investigation.  
• 
Source documentation (including original medical records) must be available to substantiate 
proper informed consent procedures, adherence to CIP procedures, adequate reporting and 
follow-up of adverse events, accuracy of data collected on case report forms, and device 
information.  
• 
The Investigator/site will permit access to such records. A monitoring visit sign-in log will be 
maintained at the site. The Investigator will agree to dedicate an adequate amount of time to the 
monitoring process. The Investigator and/or research coordinator will be available for monitoring 
visits. It is expected that the Investigator will provide the monitor with a suitable working 
environment for review of clinical investigation-related documents. 
10.6 Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical emergencies 
when the deviation is necessary to protect the rights, safety and well-being of the subject or eliminate an 
apparent immediate hazard to the subject. In that event, the Investigator will notify Sponsor immediately 
by phone or in writing.  
 
No waivers for CIP deviations will be granted by the Sponsor.  All deviations must be reported to the 
Sponsor using the Deviation CRF. The occurrence of CIP deviations will be monitored by the Sponsor for 
evaluation of investigator compliance to the CIP and regulatory requirements and dealt with according to 
written procedures. Investigators will inform their IRB/EC or equivalent committee of all CIP deviations in 
accordance with their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and not 
limited to):  

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• Visiting the investigator and/or delegate 
• Telephoning the investigator and/or delegate 
• Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP or any other conditions of the clinical 
investigation may result in further escalation in accordance with the Sponsor’s written procedures, 
including securing compliance or, at its sole discretion, Sponsor may terminate the investigator's 
participation in the clinical investigation.  
10.7 Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical investigation records, including 
source documentation, for inspection during a Quality Assurance audit.  
 
In the event that an investigator is contacted by a Regulatory Agency in relation to this clinical 
investigation, the Investigator will notify Sponsor immediately. The Investigator and Research 
Coordinator must be available to respond to reasonable requests and audit queries made during the 
audit process. The Investigator must provide Sponsor with copies of all correspondence that may affect 
the review of the current clinical investigation (e.g., Form FDA 483, Inspectional Observations, Warning 
Letters, Inspection Reports, etc.). Sponsor may provide any needed assistance in responding to 
regulatory audits. 
10.8 Sponsor Auditing 
1. The Sponsor shall prepare an audit plan as well as the operating procedures for the related duties 
and conduct audits in accordance with the audit plan and the operating procedures. 
2. Individual engaged in auditing (hereinafter referred to as "auditor") shall be different than those in 
charge of medical device development or monitoring. 
3. The auditor shall prepare an audit report documenting the matters confirmed in the audit to certify 
and verify that the audit has been conducted and submit them to the Sponsor. 
10.9 Committees  
 Steering Committee 
 
The Steering Committee is responsible for overseeing the scientific and operational aspects of the 
clinical investigation. This committee will meet regularly to monitor subject enrollment, general data 
collection and non-compliance with the CIP at individual centers, to review operational issues that may 
arise and warrant a CIP amendment or other corrective action and to determine policy regarding any 
publications arising from data generated from the performance of the clinical investigation. 

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 Publications Committee 
 
A Publication Committee may be established to oversee clinical investigations publications, including 
publication planning and authorship determinations. Publication Committee membership may include, 
Principal Investigator, a representative of the Sponsor and a statistician. The Publication Committee will 
determine policy and strategies regarding individual presentations and/or publications arising from 
clinical investigation generated data. The committee will also review all external requests for accessing 
clinical investigation-related data and strategies aligning with the Sponsor’s presentation and publication 
team expectations. The committee will also follow the Sponsor’s applicable policies and Standard 
Operating Procedures. 
11.0 DATA HANDLING AND RECORD KEEPING  
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in data 
collection for the duration of the clinical investigation.  
 
CRF data collection will be performed through a secure web portal and only authorized personnel will 
access the Electronic Data Capture (EDC) system using a unique username and password to enter, 
review or correct data. Passwords and electronic signatures will be strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor.    
 
At the conclusion of the clinical investigation, completed CRF images with the date-and-time stamped 
electronic audit trail indicating the user, the data entered, and any reason for change (if applicable) will 
be provided to the investigational sites.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical investigation progress records, 
laboratory reports, CRFs, signed ICFs, correspondence with the IRB/EC and clinical investigation 
monitor/Sponsor, adverse event reports, and information regarding subject discontinuation or completion 
of the clinical investigation. 
11.1 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical investigation.  
The Sponsor implements technical and physical access controls to ensure that Personal Information is 
accessible only to and processed only on a ‘need to know’ basis, including periodic review of access 
rights, and revocation of access when an individual’s employment is terminated or the individual 
transitions to a role that does not require access to Personal Information, and appropriate restrictions on 
physical access to premises, facilities, equipment, and records containing Personal Information. 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management systems only 
pseudonymous Personal Information (key-coded) necessary to conduct the Clinical Investigation, such 

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as the patient’s medical condition, treatment, dates of treatment, etc. The Sponsor discloses as part of 
the clinical investigation informed consent process that some Sponsor representatives still may see 
Personal Information at the participating sites for technical support of the participating physicians on the 
device implant or procedures, monitoring and quality control purposes. Confidentiality of Personal 
Information will be observed by all parties involved at all times throughout the clinical investigation. The 
privacy of each subject and confidentiality of his/her information will be preserved in reports and when 
publishing any data. 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, theft, 
destruction, loss or alteration. Clinical Investigation data are encrypted in transit and at rest.  
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law 
and industry best practices. 
11.2 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, and 
issuing and resolving data discrepancies. If appropriate, the DMP may be updated throughout the 
duration of the clinical investigation. All revisions will be tracked and document controlled. 
11.3 Source Documentation  
Regulations and GCP require the Investigator to maintain information in the subject’s original medical 
records that corroborates data collected on the CRFs. In order to comply with these regulatory 
requirements/GCP, the following information should be included in the subject record at a minimum and 
if applicable to the clinical investigation: 
• 
Medical history/physical condition of the subject before involvement in the clinical investigation 
sufficient to verify CIP entry criteria 
• 
Dated and signed notes on the day of entry into the clinical investigation referencing the Sponsor, 
CIP number, subject ID number and a statement that informed consent was obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 
• 
Adverse events reported and their resolution, including supporting documents, such as discharge 
summaries, catheterization laboratory reports, ECGs, and lab results including documentation of 
site awareness of SAEs and of investigator assessment of device relationship for SAEs. 
• 
CIP-required laboratory reports and 12-lead ECGs, reviewed and annotated for clinical 
significance of out of range results (if applicable).  
Note: With electronic medical records some clinical sites may be able to annotate that the labs or 
ECG have been reviewed in the system. For those sites that do not have such capability, the labs 
or ECG may be able to be printed or signed.  

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• 
Notes regarding CIP-required and prescription medications taken during the clinical investigation 
(including start and stop dates) 
• 
Subject’s condition upon completion of or withdrawal from the clinical investigation 
• 
Any other data required to substantiate data entered into the CRF 
• 
Patient reported outcome measures may be completed using CRF worksheets. These serve as 
the source documentation. 
11.4 Case Report Form Completion  
Primary data collection based on source-documented hospital and/or clinic chart reviews will be 
performed clearly and accurately by site personnel trained on the CIP and CRF completion. The 
investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor on the CRFs and in all required reports. 
Data on CRFs will be collected for all subjects who sign an informed consent form, including subjects 
who may not meet all inclusion/exclusion criteria during screening at the index procedure. 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system deployed 
by the Sponsor. An electronic audit trail will be used to track any subsequent changes of the entered 
data. 
11.5 Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the clinical 
investigation as per the applicable regulatory record retention requirements. The Investigator must obtain 
permission from Sponsor in writing before destroying or transferring control of any clinical investigation 
records. 
11.6 Devices Accountability 
The VFR study is an investigation using market released medical devices and device accountability is 
not required.   
12.0 ETHICAL CONSIDERATION 
 
12.1 Institutional Review Board Review and Approval 
Institutional Review Board (IRB) approval for the CIP and ICF/other written information provided to the 
patient will be obtained by the Principal Investigator at each investigational site prior to consenting and 
enrolling patients in this clinical investigation. The approval letter must be received prior to the start of 
this clinical investigation and a copy must be provided to the Sponsor.  
 
Any amendments to the CIP as well as associated ICF changes will be submitted to the IRB and written 
approval obtained prior to implementation, according to each institution’s IRB requirements.  
 

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No changes will be made to the CIP or ICF or other written information provided to the patient without 
appropriate approvals, including IRB, the Sponsor, and the regulatory agencies (if applicable).  
 
Until the clinical investigation is completed, the Investigator will advise his/her IRB of the progress of this 
clinical investigation, per IRB requirements. Written approval must be obtained from the IRB yearly to 
continue the clinical investigation, or according to each institution’s IRB requirements.  
 
No investigative procedures other than those defined in this CIP will be undertaken on the enrolled 
subjects without the written agreement of the IRB and the Sponsor. 
13.0 CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical investigation closure.  
14.0 PUBLICATION POLICY 
The data and results from the clinical investigation are the sole property of the Sponsor. The Sponsor 
shall have the right to access and use all data and results generated during the clinical investigation. The 
Investigators will not use this clinical investigation-related data without the written consent of the Sponsor 
for any purpose other than for clinical investigation completion or for generation of publication materials, 
as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or 
presented before the multi-center results. Any proposals for publications or presentations by the 
investigators must be reviewed and approved by the Sponsor in a timely manner to enable Sponsor 
review in compliance with the Sponsor’s publication policy set forth in the Clinical Trial Agreement. 
 
The Sponsor will be responsible for determining whether to register the clinical investigation on 
www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of 
Medical Journal Editors guidelines, or any other applicable guidelines. In the event Sponsor determines 
that the clinical investigation should be registered, Sponsor shall be responsible for any such registration 
and results posting as required by the ClinicalTrials.gov website. Institution and/or Principal 
Investigator(s) shall not take any action to register the clinical investigation. 
15.0 RISK ANALYSIS 
 
15.1 Anticipated Clinical Benefits 
The Virtual Flow Reserve (VFR) software provides an estimate of FFR to facilitate the assessment of the 
hemodynamic significance of coronary lesions imaged by optical coherence tomography (OCT). VFR 
and FFR have the same mathematical definition, but VFR is based on model-derived pressure losses 
rather than measured pressure losses. FFR has been a useful tool to assess the functional severity of a 

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stenotic lesion in a coronary artery and determine the need for revascularization in many clinical studies 
(1,2); VFR is expected to provide this same benefit that FFR provides to the clinician.   
15.2 Foreseeable Adverse Events and Anticipated Adverse Device Effects 
Risks associated with PressureWire and OCT imaging system, together with their likely incidence, are 
described in the IFU and Appendix IV.  There may be risks related to the device to be used in this 
investigation that are unknown at present.  Likewise, the exact frequency of the risk may be unknown. 

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15.3 Residual Risks Associated with the Device Under Investigation, as Identified in the 
Risk Analysis Report 
The residual risks to the patient were identified from literature review or the complaint data review. 
15.4 Risks Associated with Participation in this Clinical Investigation 
The risks related to the procedure have been included in Appendix IV. 
15.5 Steps Taken to Control or Mitigate Risks 
In-depth recommendations, special precautions and instructions regarding patient selection, device 
handling, device placement and system removal are included in the IFU. 
Risks associated with the use of PressureWire and OCT Imaging system during this clinical study are 
minimized through investigator selection and training, pre-specified patient eligibility requirements, and 
study monitoring to ensure adherence to the protocol. 
These risk management aspects are detailed below: 
Investigator Selection and Training: It is also stated in the IFU that the devices can only be used by 
physicians who have received appropriate training on how to use the device. This statement is 
interpreted to mean that the physician users are expected to be aware of the known and foreseeable 
safety risks associated with the use of the devices including the surgical and/or non-surgical treatment of 
these conditions. 
• Only physicians who are skilled in the manipulation of catheter-based technology in the vasculature and 
heart and have a good understanding of the risks associated with these manipulations, will be selected 
as investigators for this trial.  
• Emergency surgical back-up should be available as per the institution’s standard procedures. 
•Preparation of the PressureWire and Dragonfly Imaging Catheter device and performance of the 
ILUMIEN OPTIS, OPTIS Integrated, and OPTIS Mobile systems will be in accordance with the device 
IFUs 
• Training of Investigators on the CIP 
• Pre-specified patient eligibility requirements - as stated in Section 5 of the protocol. 
Ensuring strict adherence to the clinical investigation protocol 
The clinical investigation will be carefully monitored by the Sponsor monitor (or designee) to ensure 
adherence to the Clinical Investigational Plan. Adverse events and device deficiencies will be reported to 
Abbott/designee and will be monitored internally for safety surveillance purposes.  

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15.6 Risk to Benefit Rationale 
The foreseeable rates of the anticipated adverse events associated with the procedure of FFR and OCT 
imaging systems are all below 10% (see Appendix IV). Moreover, as detailed in Section 15.1, evidence 
indicates that use of physiological measurements, such as VFR and FFR, in diagnosing the functional 
significance of coronary stenoses based on the lumen information obtained through OCT image pullback 
can potentially support the functional evaluation of coronary artery disease and procedural scenario 
planning can aid the decision-making of qualified clinicians, in conjunction with the clinical history and 
symptoms of patients as well as other diagnostic tests according to clinician’s professional judgment. In 
turn, the following clinical benefits may be observed: (a) improved outcomes of PTCA (percutaneous 
transcutaneous coronary angioplasty), (b) reduced incidence of major adverse coronary events in 
patients being treated for complex CAD (coronary artery disease), (c) improved accuracy in the 
identification of hemodynamically relevant stenosis compared to use of angiography alone, and (d) 
reduced mortality and myocardial infarction compared to use of angiography alone. 
 
 

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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Acronym or 
Abbreviation 
Complete Phrase or Definition 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AUC 
Area under curve 
CABG 
Coronary Artery Bypass Graft 
CAD 
Coronary Artery Disease 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
FDA 
Food and Drug Administration 
FN 
False Negative 
FP 
False Positive 
CRF 
Case Report Form 
DD 
Device Deficiency 
dL 
Deciliter 
DMP 
Data Management Plan 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EDC  
Electronic Data Capture 
FDA 
Food and Drug Administration (U.S.) 
FFR 
Fractional Flow Reserve 
GCP  
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICF 
Informed Consent Form  
IFU 
Instructions for Use 
IRB 
Institution Review Board 
LAR 
Legally Acceptable Representative 
LCB 
Lower Confidence Bound 
LV 
Left Ventricular 
LVEF 
Left Ventricular Ejection Fraction 
MI 
Myocardial Infarction 
mm 
Millimeter 

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Acronym or 
Abbreviation 
Complete Phrase or Definition 
NPV 
Negative Predictive Value 
NSTEMI 
Non-ST Elevation Myocardial Infarction 
NYHA 
New York Heart Association 
OCT 
Optical Coherence Tomography 
Pa 
Aortic Pressure 
PCI 
Percutaneous Coronary Intervention 
Pd 
Distal Coronary Arterial Pressure 
PG 
Performance Goal 
PPV 
Positive Predictive Value 
RFR 
Resting Full-cycle Ratio 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SBP  
Systolic Blood Pressure 
STEMI 
ST Elevation Myocardial Infarction 
TIMI 
Thrombolysis in Myocardial Infarction 
TN 
True Negative 
TP 
True Positive 
US 
United States 
VFR 
Virtual Flow Reserve  
 
 

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APPENDIX II: DEFINITIONS 
Adverse Event (AE): 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device under clinical investigation. 
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. 
Serious Adverse Event (SAE): 
An adverse event that led to: 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o a life-threatening illness or injury OR 
o a permanent impairment to a body structure or a body function OR 
o an in-patient or prolonged hospitalization OR 
o a medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function OR 
o chronic disease 
• 
Fetal distress, fetal death or a congenital abnormality or birth defect 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not 
considered a serious adverse event. 
Adverse Device Effect (ADE): 
An adverse event related to the use of an investigational medical device. 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 

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Serious Adverse Device Effect (SADE): 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
Device Deficiency (DD): 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors and 
inadequate labeling. 
Thrombolysis in Myocardial Infarction (TIMI) Flow Grading System: 
Grade 0 (no perfusion): There is no antegrade flow beyond the point of occlusion. 
Grade 1 (penetration without perfusion): The contrast material passes beyond the area of obstruction but 
“hangs up” and fails to opacify the entire coronary bed distal to the obstruction for the duration of the 
cine-angiographic filming sequence. 
Grade 2 (partial perfusion): The contrast material passes across the obstruction and opacifies the 
coronary bed distal to the obstruction. However, the rate of entry of contrast material into the vessel 
distal to the obstruction or its rate of clearance from the distal bed (or both) is perceptibly slower than its 
entry into or clearance from comparable areas not perfused by the previously occluded vessel (e.g., the 
opposite coronary artery or the coronary bed proximal to the obstruction). 
Grade 3 (complete perfusion): Antegrade flow into the bed distal to the obstruction occurs as promptly as 
antegrade flow into the bed from the involved bed and is as rapid as clearance from an uninvolved bed in 
the same vessel or the opposite artery. 
NYHA Classification: 
Class I: Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary 
physical activity does not cause undue fatigue, palpitation, dyspnea, or angina pain. 
Class II: Subjects with cardiac disease resulting in slight limitation of physical activity. They are 
comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. 
Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. They are 
comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. 
Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without 
discomfort. Symptoms of heart failure or anginal syndrome may be present even at rest. If any physical 
activity is undertaken, discomfort is increased. 
 
 

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Reference Vessel Diameter (RVD):    
Average diameter of proximal and distal healthy segments by visual estimation. “Normal” reference 
segments are selected proximal and distal to the stenosis and averaged to define the reference vessel 
diameter. 
Minimum Lumen Diameter (MLD):  
The smallest measured luminal diameter in a diseased segment (as measured by visual estimation).  
Percent Diameter Stenosis:    
The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when 
possible) by visual estimation 
Severe Valvular Disease:  
According to 2017 American Heart Association/American College of Cardiology (AHA/ACC) Guidelines 
describe severe stages in the progression of valvular heart disease (VHD) 
Stage 
Definition 
Description 
C 
  
  
Asymptomatic 
severe  
  
  
Asymptomatic patients who have reached the criteria for severe 
VHD 
C1: Asymptomatic patients with severe VHD in whom the left or 
right ventricle remains compensated 
C2: Asymptomatic patients who have severe VHD, with 
decompensation of the left or right ventricle 
D 
Symptomatic severe  Patients who have developed symptoms as a result of VHD 
 
 

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APPENDIX III: SITE CONTACT INFORMATION 
A list of trial site coordinators can be obtained upon request from the Clinical Project Manager for the 
clinical investigation.  
 

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APPENDIX IV: RATES OF FORESEEABLE ADVERSE EVENTS 
The anticipated potential adverse events with corresponding rates are shown in Tables A and B below. 
TABLE A: ANTICIPATED ADVERSE EVENTS AND RATES FOR FFR 
Anticipated Adverse Events for FFR 
Frequency Rate Ranges 
Category 
POSSIBLE 
(≥ 0.5%) 
UNLIKELY 
(≥ 0.1 but < 
0.5%) 
REMOTE (≥ 
0.001% but < 
0.1%) 
EXTREMELY 
UNLIKELY 
(< 0.001%) 
Bleeding 
X 
 
 
 
Hypotension 
 
X 
 
 
Chest pain 
X 
 
 
 
Vessel dissection or occlusion 
 
X 
 
 
Perforation (vascular perforation) 
 
X 
 
 
Spasm or abrupt closure 
 
 
 
X 
Serious arrhythmias 
X 
 
 
 
Myocardial infarction 
X 
 
 
 
Congestive heart failure 
 
X 
 
 
Embolus 
 
X 
 
 
Thrombosis 
 
30 days 
follow up - X 
 
 
≥ 1 year 
follow-up - X 
Cardiac tamponade/pericardial effusion 
 
X 
 
 
Prolonged procedure 
 
X 
 
 
Foreign body in patient 
 
 
 
X 
Urgent revascularization 
X 
 
 
 
Pneumothorax 
 
 
 
X 
Stroke/cerebral vascular accident 
(CVA)/transient ischemic attack (TIA) 
X 
 
 
 
Local and/or systemic infection 
 
X 
 
 
Renal insufficiency 
 
 
 
X 
Death 
X 
 
 
 
Device-related events 
 
X 
 
 
 

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TABLE B: ANTICIPATED ADVERSE EVENTS AND RATES FOR OCT 
Anticipated Adverse Events for OCT 
Frequency Rate Ranges 
Category 
POSSIBLE 
(≥ 0.5%) 
UNLIKELY 
(≥ 0.1 but < 
0.5%) 
REMOTE (≥ 
0.001% but < 
0.1%) 
EXTREMELY 
UNLIKELY 
(< 0.001%) 
Allergic reaction to the contrast media or 
drug administered for the procedure 
 
X 
 
 
Bleeding 
X 
 
 
 
Arterial dissection, injury or perforation 
X 
 
 
 
Abnormal heart rhythm or arrhythmias 
X 
 
 
 
Unstable angina 
X 
 
 
 
Coronary artery spasm 
X 
 
 
 
Thrombus formation, abrupt closure, or 
total occlusion 
X 
 
 
 
Embolism 
 
 
 
X 
Myocardial ischemia 
X 
 
 
 
Acute myocardial infarction 
X 
 
 
 
Repeat revascularization 
X 
 
 
 
Renal insufficiency or failure from contrast 
media use 
X 
 
 
 
Death 
X 
 
 
 
Catheter access site reactions: sterile 
inflammation or granuloma 
 
 
 
X 
Tissue necrosis 
 
 
 
X 
 
 

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APPENDIX V: CASE REPORT FORMS 
The Final Case Report Forms will be provided under a separate cover as part of pertinent regulatory 
submissions and study documentation/information to clinical sites.  
 
 
 

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APPENDIX VI: INFORMED CONSENT FORM 
The Final Informed Consent Form will be provided under a separate cover as part of pertinent regulatory 
submissions and study documentation/information to clinical sites.  
 
 
 

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APPENDIX VII: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor Clinical Project Manager 
for the clinical investigation. 
 
 
 

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• 
Additional language on collecting and uploading 
intermediate OCT pullbacks  
• 
Revision on pressure drift guideline to be 
consistent throughout the CIP 
o Pressure drift of > 3 mmHg 
• 
Addition of 3 additional imaging exclusion criteria  
o Severe vessel tortuosity or calcification in 
the target vessel such that it is unlikely that 
the OCT catheter can be delivered 
o Inability to receive intracoronary 
nitroglycerin prior to OCT or FFR 
o Use of flush media other than radiographic 
contrast 
• 
Addition of a general exclusion on COVID-19  
o Subject had active COVID-19 symptoms 
and/or a positive test result within the prior 2 
months 
2 
C 
16JUL2020 
• 
Addition of hematocrit to baseline assessment  
• 
Addition of a general exclusion criteria on double 
enrollment in clinical study  
o Participation in another clinical study of an 
investigational drug or device 
• 
Add definition on qualified OCT pullback image 
length 
o OCT pullback image will be qualified as long 
as all disease segment was captured 
• 
Revision on pressure drift guideline according to 
core laboratory definition  
o Pressure drift of > 0.03; i.e. Pd and Pa ratio 
value < 0.97 or > 1.03, unless physiology 
measurements are repeated after re-
equalization  
3 
D 
3SEP2020 
• 
Clarification and addition of silent ischemia in 
general exclusion criteria  
o Clinical presentation with or history of stable 
angina, unstable angina, or silent ischemia 
(defined as abnormal stress test or abnormal 
invasive physiology assessment) that has led 
to the procedure 
• 
Removal of site study investigator and study 
principle investigator signature pages as the 
study is conducted in US only 

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• 
Changing number of participated sites from 25 to 
30 sites  
4 
E 
28JAN21 
• 
Change the number of a sample size from 233 to 
310 and update sample size language with no 
dual vessel and positive FFR post-PCI 
assumption 
• 
Remove patient cap per site  
• 
Change duration of enrollment to 15 months and 
the total study duration to be 27 months 
• 
Add a clarification on the bifurcation lesions and 
flowchart 
• 
Add additional information on general exclusion 
criteria  
o Severe valvular heart disease or history 
of valve repair or replacement 
o Presence of any myocardial bridge (MB), 
regardless of vessel location  
• 
Add a clarification on severe valvular disease  
• 
Change mandatory post-PCI data collection step 
to optional  
• 
Add additional details on pressure drift checking 
• 
Add additional details on checking OCT pullback 
after the run to ensure all lesion segments are 
captured  
• 
Add clarification details on the 
blinding/unblinding step. Change flowchart 
diagram and frequency of OCT pullback transfer 
after a quality check from core laboratory to be 
every 50 patients instead of at the end of the 
enrollment to facilitate faster analysis of the VFR  
• 
Correct the order of guidewire removal timepoint 
in procedure step in Appendix XI 
5 
F 
14APR21 
• 
Change the pre-PCI procedure order to have 
physiological measurement conducted first 
before OCT imaging 
• 
Change 5.5 section heading from ‘subject 
withdrawal’ to ‘subject discontinuation’  
• 
Add statement on protocol deviation in Section 
3.2.2, ‘If the enrollment cap is implemented, 
protocol deviation(s) will be given if the sites do 
not follow the capping criteria.’  
• 
Add a new general exclusion criteria 

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o Presence of aneurysm in the target 
vessel   

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APPENDIX IX: CIP SUMMARY 
Clinical Investigation Name 
and Number 
CRD_1006 FUSION 
Title 
Validation of OCT-based FUnctional diagnoSIs of corONary stenosis 
(FUSION) 
Objective(s) 
To validate the diagnostic performance of VFR by comparing it 
against a reference standard, fractional flow reserve (FFR) 
Number of Subjects 
Required for Inclusion in 
Clinical Investigation 
N = 310 
Up to 30 centers in the US 
Clinical Investigation 
Design 
Prospective, single-arm, multi-center 
Primary Endpoint(s) 
Sensitivity and specificity of VFR against FFR 
Secondary Endpoints  
• 
Overall diagnostic accuracy  
• 
Positive predictive value (PPV)  
• 
Negative predictive value (NPV) 
• 
Correlation between VFR and FFR  
• 
Area under curve (AUC) against FFR 
Subject Follow-up 
No follow-up 
Inclusion Criteria 
• 
Age ≥18 years 
• 
Patient provides written informed consent 
• 
Scheduled for clinically indicated coronary catheterization with 
the intent to perform physiologic assessment to guide physician 
clinical course (in lesions with visual % diameter stenosis 40-
90%), if clinically indicated  
• 
Subject is undergoing invasive FFR with Adenosine (high-dose 
intra-coronary (IC) [200 μg for the left and or 100 μg for the right 
coronary artery] or 140 μg/kg/min for intravenous (IV)) used as 
hyperemic stimulus 
• 
Clinical presentation with or history of stable angina, unstable 
angina, or silent ischemia (defined as abnormal stress test or 
abnormal invasive physiology assessment) that has led to the 
procedure  
General Exclusion Criteria 
• 
Prior history of myocardial infarction (MI) in the target vessel     
• 
Presence of acute ST Elevation Myocardial Infarction (STEMI) 

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• 
Culprit vessel of Non-ST Elevation Myocardial Infarction 
(NSTEMI) 
• 
TIMI flow < Grade 3 at baseline or visible thrombus 
• 
Prior history of coronary artery bypass grafting (CABG) 
• 
Prior heart transplant 
• 
Severe valvular heart disease or history of valve repair or 
replacement 
• 
Prior history of PCI with stent in target vessel, or target vessel 
involves in-stent restenosis. 
• 
Target coronary vessel is supplied by major collaterals or is 
supplying major collaterals to a CTO (chronic total occlusion) 
• 
CTO in the target vessel 
• 
Severe diffuse disease observed in target vessel defined as the 
presence of diffuse, serial gross luminal irregularities present in 
the majority of the coronary tree 
• 
Presence of any myocardial bridge (MB), regardless of vessel 
location  
• 
Contraindication for FFR examination or administration of 
vasodilators 
• 
Known LVEF ≤45% 
• 
Target lesion involves Left Main coronary artery or ostial right 
coronary artery  
• 
Known renal insufficiency (eGFR < 30 ml/kg/m2 or serum 
creatinine ≥ 2.5 mg/dL) 
• 
Heart Failure NYHA Class III or IV 
• 
Subject is pregnant (For a female subject of childbearing 
potential, a pregnancy test must be performed within 14 days 
(≤14 days) prior to the index procedure per site standard test) 
• 
Subject has or had active COVID-19 symptoms and/or a positive 
test result within the prior 2 months 
• 
Participation in another clinical study of an investigational drug or 
device 
• 
Presence of aneurysm in the target vessel   
Imaging and Pressure 
Tracing Exclusion Criteria 
• 
Artifact in pre-PCI OCT for the target lesion or in the event of 
multiple target lesions, artifact in pre-PCI OCT for ALL target 
lesions   
• 
Target lesion requires any preparation (including but not limited 
to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT 
and physiology measurements, or in case of multiple target 
lesions, ALL target lesions require any preparation (including 
but not limited to balloon dilatation, atherectomy, etc.) prior to 
pre-PCI OCT and physiology measurement 

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• 
Severe vessel tortuosity or calcification in the target vessel such 
that it is unlikely that the OCT catheter can be delivered 
• 
Target lesion not imaged by OCT or in the event of multiple 
target lesions, ALL target lesions not imaged by OCT 
• 
Pressure drift of > 0.03; i.e. Pd and Pa ratio value < 0.97 or > 
1.03, unless physiology measurements are repeated after re-
equalization  
• 
Target lesion or significant CAD beyond 60 mm from coronary 
ostium; i.e. not able to clearly image and capture all disease 
segment with OCT in 1 run.  
• 
Incorrectly done or unsuccessful catheter purge and/or contrast 
flush  
• 
Presence of plaque rupture and/or intravascular hematoma in 
target vessel (visual % diameter stenosis ≥ 40%) 
• 
Inability to receive intracoronary nitroglycerin prior to OCT or 
FFR 
• 
Use of flush media other than radiographic contrast 
 
 
 

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APPENDIX X: REFERENCES 
1. 
Pijls NHJ, Fearon WF, Tonino PAL, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, 
Manoharan G, Engstrøm T and others. Fractional Flow Reserve Versus Angiography for Guiding 
Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease: 2-
Year Follow-Up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel 
Evaluation) Study. Journal of the American College of Cardiology 2010;56(3):177-184. 
2. 
Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrøm T, Kääb S, 
Dambrink J-H, Rioufol G and others. Five-Year Outcomes with PCI Guided by Fractional Flow 
Reserve. New England Journal of Medicine 2018;379(3):250-259. 
3. 
van Nunen LX, Zimmermann FM, Tonino PAL, Barbato E, Baumbach A, Engstrøm T, Klauss V, 
MacCarthy PA, Manoharan G, Oldroyd KG and others. Fractional flow reserve versus 
angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-
year follow-up of a randomised controlled trial. The Lancet 2015;386(10006):1853-1860. 
4. 
Neumann F-J, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet 
J-P, Falk V, Head SJ and others. 2018 ESC/EACTS Guidelines on myocardial revascularization. 
European Heart Journal 2018;40(2):87-165. 
5. 
Patel MR, Calhoon JH, Dehmer GJ, Grantham JA, Maddox TM, Maron DJ, Smith PK. 
ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary 
Revascularization in Patients With Stable Ischemic Heart Disease. A Report of the American 
College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic 
Surgery, American Heart Association, American Society of Echocardiography, American Society 
of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of 
Cardiovascular Computed Tomography, and Society of Thoracic Surgeons 2017;69(17):2212-
2241. 
6. 
Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GBJ, Mauri L, Schwartz 
RS, Shaw LJ. Rationale and design of the DeFACTO study. Journal of Cardiovascular Computed 
Tomography 2011;5(5):301-309. 
7. 
Min JK, Leipsic J, Pencina MJ, Berman DS, Koo B-K, van Mieghem C, Erglis A, Lin FY, Dunning 
AM, Apruzzese P and others. Diagnostic Accuracy of Fractional Flow Reserve From Anatomic CT 
Angiography. JAMA 2012;308(12):1237-1245. 
8. 
Nørgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, 
Bezerra H and others. Diagnostic Performance of Noninvasive Fractional Flow Reserve Derived 
From Coronary Computed Tomography Angiography in Suspected Coronary Artery Disease: The 
NXT Trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). Journal of the 
American College of Cardiology 2014;63(12):1145-1155. 
9. 
Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane 
AJ, Kornowski R, Greenberg G and others. Accuracy of Fractional Flow Reserve Derived From 
Coronary Angiography. Circulation 2019;139(4):477-484. 
10. 
Min JK, Koo B-K, Erglis A, Doh J-H, Daniels DV, Jegere S, Kim H-S, Dunning A, Defrance T, 
Leipsic J. Effect of image quality on diagnostic accuracy of noninvasive fractional flow reserve: 

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Page 67 of 70 
Results from the prospective multicenter international DISCOVER-FLOW study. Journal of 
Cardiovascular Computed Tomography 2012;6(3):191-199. 
11. 
Nørgaard BL, Gaur S, Leipsic J, Ito H, Miyoshi T, Park S-J, Zvaigzne L, Tzemos N, Jensen JM, 
Hansson N and others. Influence of Coronary Calcification on the Diagnostic Performance of CT 
Angiography Derived FFR in Coronary Artery Disease: A Substudy of the NXT Trial. JACC: 
Cardiovascular Imaging 2015;8(9):1045-1055. 
12. 
Wijns W, Shite J, Jones MR, Lee SWL, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra 
H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention 
impacts physician decision-making: ILUMIEN I study. European heart journal 2015;36(47):3346-
3355. 
13. 
Šimundić A-M. Measures of Diagnostic Accuracy: Basic Definitions. EJIFCC 2009 Jan:19 (4): 
203-211. 
 
 

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APPENDIX XI:  PROCEDURAL STEPS 
The following sections outline procedural steps including co-registration of imaging and pressure 
measurements. In all cases, the investigator must adhere to the IFUs.  
Any vessel preparation (if necessary) with balloon dilation or atherectomy must be performed only after 
pre-PCI physiological indices measurement and OCT have been performed.  
Pre-PCI Angiography 
1. Administer at least 100 µg of IC nitroglycerin. 
2. Perform 2-contralateral cine angiograms of the culprit vessel without panning.  
Pre-PCI Physiological Indices 
1. Zero aortic transducer. 
2. Flush and zero PressureWireTM outside the body. 
3. Administer at least 100 µg of IC nitroglycerin. 
4. Advance PressureWire to equalize position (guide disengaged). 
5. Flush the guiding catheter to ensure appropriate aortic waveform (dicrotic notch). 
6. Equalize PressureWire. 
7. Remove any other coronary wires from within the target vessel. 
8. Advance the PressureWire at least 10 mm distal to the most distal target lesion.  
9. Document PressureWire position with cine documentation with contrast administration. 
10. Flush the guiding catheter with saline. 
11. Record the baseline blood pressure (with confirmation of distinct dicrotic notch with guide 
disengaged). 
12. Capture Pd/Pa and RFR snapshots.  
13. Induce maximal hyperemia with Adenosine per standard institutional practice (140 μg/kg/min IV 
or high dose 200 μg or 100 μg for the left or right coronary artery IC adenosine, respectively). 
14. Record FFR. 
15. Wait until hyperemia has worn off by confirming Pd/Pa has returned to the resting value. 
a. 1 minute following IC administration 
b. 3 minutes following IV administration 
16. Record for RFR pullback (0.5mm/sec). 
17. Check for pressure drift (i.e. range on 0.97-1.03 is accepted) and record the Pd/Pa snapshot 
value in FFR mode. If drift is present, physiology measurements are repeated after re-
equalization at the aorto-ostial junction. 
18. Remove PressureWire. 
19. Upon completion of physiological measurement, record device lot and model numbers 
20. Complete Adverse Event eCRF, if applicable (adverse device effects). 
 
 
 
 

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Pre-PCI OCT 
1. Administer at least 100 µg of IC nitroglycerin if more than 10 minutes has passed since last dose. 
2. Introduce and position the Dragonfly™ lens into the distal coronary artery at the same location as 
the PressureWire sensor, beyond all suspect lesions with the aim of capturing as much of the 
coronary artery as possible.  
3. Record proximal and distal frames. 
4. Capture lens position via cine documentation prior to each pullback. 
5. Set the motorized pullback device on the “Survey Mode” at 75 mm pullback.  
6. Perform OCT pullback per IFU instruction and simultaneously perform cine angiography without 
panning in the desired angiographic co-registration view(s) during OCT pullback. 
7. Check the quality of the pullback. If the pullback started in the middle of the lesion, this pullback 
needs to be redone more distally to capture all the lesions segment. If there is presence of plaque 
rupture, hematoma, or thrombus within the pullback, this patient is a screen fail.  
8. Record contrast injection method and amount.  
9. Remove the OCT catheter. 
10. Upon completion of OCT, record device lot and model numbers. 
11. Complete Adverse Event eCRF, if applicable (adverse device effects). 
 
If the subject is no longer deemed a candidate for PCI, or the investigator decides not to continue with 
the PCI, this is the end of protocol for the subject.  
PCI (if applicable) 
1. Perform PCI as per standard practice.  
2. Record the PCI procedure details on the eCRF.  
3. Complete Adverse Event eCRF, if applicable (adverse events). 
Post-PCI study data collection step is optional but strongly recommended. If the post-PCI study data 
collection step is decided to be carried out, both the post-PCI OCT pullback and physiological 
assessment should be performed. If the subject had undergone atherectomy during PCI, post-PCI OCT 
and physiological steps are not required and that is the end of the protocol for the subject. 
(Optional) Final Post-PCI OCT   
This should be the final OCT following PCI/optimization, the time at which the wires would 
otherwise be removed for ending the procedure. 
1. Administer at least 100 µg of IC nitroglycerin. 
2. Introduce and position the Dragonfly lens into the distal coronary artery, beyond treated segment 
and all suspect lesions, at least 10 mm distal to the stent or more distal lesion with the aim of 
capturing as much of the coronary artery as possible.  
3. Capture lens position via cine documentation prior to each pullback. 
4. Ensure the motorized pullback device is set to “Survey Mode” 75 mm pullback. 
5. Perform OCT pullback per IFU instruction and simultaneously perform cine angiography without 
panning in the desired angiographic co-registration view(s) during OCT pullback  

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6. Record contrast injection method and amount.  
7. Remove the OCT catheter. 
8. Upon completion of OCT, record device lot and model numbers. 
9. Complete Adverse Event eCRF, if applicable (adverse device effects). 
(Optional) Post-PCI Physiological Indices  
1. Perform post-PCI physiological measurements according to the procedural steps outline in ‘Pre-
PCI Physiological Indices’. 
(Optional) Post-PCI Angiography 
1. Administer at least 100 µg of IC nitroglycerin. 
2. Perform 2-contralateral cine angiograms of the culprit vessel without panning. 
All pressure tracings, angiographic and OCT data will be stored digitally for subsequent analysis 
and these deidentified images and tracings must be uploaded to BioClinica and sent to the Core 
Laboratory for quality check.