Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
Conditions: Coronary Artery Disease
Sponsor: Gentuity, LLC

Confidential 
 
 
Title: 
Vis-Rx Prime Micro-Imaging 
Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
Document No. 
MISC-074 
Page 1 of 28 
Revision: 
C 
 
 
 
Vis-Rx Prime Micro-Imaging Catheter 
Clinical Evaluation Study 
(“Vis-Rx Prime Clinical Study”) 
 
 
 
 
 
 
 
 
 
 
 
Sponsor 
Gentuity, LLC 
142 North Road, Suite G 
Sudbury, MA 01776 

Confidential 
 
 
Title: 
Vis-Rx Prime Micro-Imaging 
Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
Document No. 
MISC-074 
Page 2 of 28 
Revision: 
C 
 
Table of Contents 
1 
General ................................................................................................................................................................ 3 
1.1 
Introduction ................................................................................................................................................... 3 
1.2 
Regulatory Status & Non-Significant Risk Determination ............................................................................. 3 
1.3 
Identification of the Evaluation ...................................................................................................................... 5 
1.4 
Synopsis of the Evaluation ........................................................................................................................... 6 
2 
Devices ................................................................................................................................................................ 8 
2.1 
Intracoronary Optical Coherence Tomography (HF-OCT) Imaging ............................................................. 8 
2.2 
Gentuity HF-OCT Imaging System ............................................................................................................. 11 
2.3 
Scope of the Evaluation .............................................................................................................................. 13 
3 
Justification of the Evaluation ......................................................................................................................... 13 
4 
Risks and Benefits ............................................................................................................................................ 13 
4.1 
Benefits ....................................................................................................................................................... 13 
4.2 
Risks ........................................................................................................................................................... 13 
5 
Objectives of the Evaluation ............................................................................................................................ 14 
5.1 
Clinical Performance Endpoint ................................................................................................................... 14 
5.2 
Technical Performance Endpoint ............................................................................................................... 15 
5.3 
Safety Endpoint .......................................................................................................................................... 16 
5.4 
General ....................................................................................................................................................... 16 
5.5 
Devices ....................................................................................................................................................... 17 
5.6 
Subjects ...................................................................................................................................................... 17 
5.7 
Procedures ................................................................................................................................................. 20 
6 
Statistical Analysis Plan ................................................................................................................................... 20 
6.1 
Introduction ................................................................................................................................................. 20 
6.2 
Sample Size Calculation ............................................................................................................................. 21 
6.3 
Remarks About Statistical Analysis ............................................................................................................ 22 
6.4 
Baseline Analysis ........................................................................................................................................ 22 
6.5 
Clinical Performance Analysis .................................................................................................................... 22 
6.6 
Technical Performance Analysis ................................................................................................................ 23 
6.7 
Safety Endpoint Analysis ............................................................................................................................ 23 
6.8 
Procedural Error and Device Malfunctions ................................................................................................. 23 
7 
Data Management ............................................................................................................................................. 24 
8 
Amendments to the Evaluation ....................................................................................................................... 24 
9 
Deviations from the Evaluation Protocol ....................................................................................................... 24 
10 
Statements of Compliance .............................................................................................................................. 25 
11 
Informed Consent Process .............................................................................................................................. 25 
12 
Adverse Events ................................................................................................................................................. 25 
13 
Schedule of Assessments ............................................................................................................................... 27 
14 
Revision History ............................................................................................................................................... 28 
15 
Bibliography ...................................................................................................................................................... 28 
 
 
 
 

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Title: 
Vis-Rx Prime Micro-Imaging 
Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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MISC-074 
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1 
General 
1.1 Introduction 
This evaluation is a prospective, single-arm, unblinded, multi-center clinical evaluation assessing the 
safety and imaging capabilities of the Gentuity® High-Frequency Optical Coherence Tomography (HF- 
OCT) System (“Gentuity Imaging System”) with the Vis-Rx Prime Micro-Imaging Catheter (“Vis-Rx 
Prime Catheter”), collectively called the “Gentuity device”. The device will be used in patients who are 
candidates for Percutaneous Coronary Intervention (PCI) procedures. The purpose of the study is to 
collect clinical data that can be used to support a future product regulatory submission in Europe. The 
Gentuity Imaging System that will be used under this investigation plan is the same product that is FDA 
cleared. There are no modifications to the cleared Gentuity Imaging System. The Vis-Rx Prime 
Catheter has not been reviewed by the FDA. In the United States, FDA does not require clinical data as 
part of the product 510(k) Premarket Notification review process. This protocol is similar to the Vis-Rx 
Post-Market Evaluation (“Vis-Rx PME”) protocol (NCT04533503) which was conducted to collect data 
which was later used for product regulatory submission in Europe. 
Three (3) to five (5) clinical centers will use HF-OCT imaging to participate in the study. Between 30 to 
70 subjects will be enrolled and undergo HF-OCT imaging. This clinical evaluation study is expected to 
begin in May 2024 and conclude by April 2025. The sites, investigators, and research staff will be 
selected based on their established experience using various intracoronary HF-OCT imaging 
technologies in patients who are candidates for PCI. 
System and catheter performance will be rated by the treating clinical users on a Likert scale at the end 
of each case to provide feedback. 
Study participants’ HF-OCT images will be anonymized, collected, and provided to a core laboratory to 
analyze the Clear Image Length (CIL), attained for each acquired HF-OCT image. 
1.2 Regulatory Status & Non-Significant Risk Determination 
The Gentuity Imaging System first received its initial U.S. Food and Drug Administration clearance 
(K192922) on February 20, 2020. The system was cleared with the Vis-Rx Micro-Imaging Catheter. The 
Gentuity Imaging System with the Vis-Rx Catheter Indications for Use Statement is: 
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended 
for intravascular imaging and is indicated for use in coronary arteries in patients who are 
candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter 
is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro- Imaging 
Catheter is not intended for use in a target vessel that has undergone a previous bypass 
procedure. 
The Vis-Rx Prime Catheter is the next generation micro-imaging catheter that will eventually replace 
the commercialized Vis-Rx Catheter. The Vis-Rx Prime Catheter also operates on the same FDA 
cleared Gentuity Imaging System. Both catheters share the exact same Indications for Use Statement 
and intent-to-treat population as well as a similar design and manufacturing process. The Vis-Rx Prime 

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Title: 
Vis-Rx Prime Micro-Imaging 
Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
Document No. 
MISC-074 
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Revision: 
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Catheter is primarily being designed to reduce the manufacturing and material costs associated with 
the Vis-Rx Catheter. Additionally, minor changes to its design are also being implemented. This 
includes a modified catheter tip design that will improve the deliverability of the catheter by reducing 
potential friction. 
The Gentuity Imaging System that will be used under this investigation plan is the same product that is 
FDA cleared. There are no modifications to the cleared Gentuity Imaging System. The Vis-Rx Prime 
Catheter has not been reviewed by the FDA. In the United States, FDA does not require clinical data as 
part of the product 510(k) Premarket Notification review process. The protocol is similar to the Vis-Rx 
Post-Market Evaluation (“Vis-Rx PME”) protocol (NCT04533503) which was conducted to collect data 
that would be used for EU submission. 
For the purposes of this research study, Gentuity has classified the Vis-Rx Prime Catheter as a Non- 
Significant Risk (NSR) device, and that the device does not meet the definition of a Significant Risk 
(SR) device. As a result of this decision, the protocol does not require an Investigational Device 
Exemption. This decision is based on Gentuity determining the Vis-Rx Prime Catheter does not meet 
FDA’s definition of an SR device under 21 CFR 812.3(m). 
The rationale for this NSR decision is based on meeting the following regulations: 
1. The device is not an implant and does not present a potential for serious risk to the health, 
safety, or welfare of a subject. The catheter is placed in the artery for several minutes to obtain 
an image of the artery, after which it is removed. 
2. The device is not purported or does not represent to be for a use in supporting or sustaining 
human life and does not present a potential for serious risk to the health, safety, or welfare of a 
subject. The device is used as a diagnostic tool and is not intended to allow direct diagnosis or 
monitoring of a patient. The device is intended for imaging of the coronary artery. 
3. The device is not for use of substantial importance in the diagnosis, curing, mitigating, or 
treating disease, or otherwise preventing impairment of human health and does not present a 
potential for serious risk to the health, safety, or welfare of a subject. The device is intended for 
intravascular imaging and is indicated for use in coronary arteries in patients who are 
candidates for transluminal interventional procedures (e.g., stent placement). It is not required 
that a physician use HF-OCT, in comparison, where angiography is required to perform PCI 
procedures. There are multiple types of additional imaging modalities that a physician may 
choose to use as part of evaluating a patient’s arteries (e.g., HF-OCT, IVUS, MRI, CT). 
4. The device does not present a potential for serious risk to the health, safety, or welfare of a 
subject. 
There are no anticipated changes to the contraindications, warnings, and caution statements as well as 
expected product complications and risks associated with use of the Vis-Rx Prime catheter when 
compared to the Vis-Rx Catheter. As a result, similar Instructions for Use apply to use of the new Vis- 
Rx Prime Catheter. 

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Title: 
Vis-Rx Prime Micro-Imaging 
Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
Document No. 
MISC-074 
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Revision: 
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1.3 
Identification of the Evaluation 
This evaluation is entitled the “Vis-Rx Prime Micro-Imaging Clinical Evaluation Study”, or “Vis-Rx Prime 
Clinical Study”. 
The sponsoring organization of this clinical evaluation is: 
Gentuity, LLC 
142 North Road, Suite G 
Sudbury, MA 01776  
 
The sponsor has designated the following point(s) of contact for questions or communication regarding 
this clinical evaluation: 
 
Sharon Timberlake, Vice President, Clinical, Quality & Regulatory Affairs 
Telephone: (978) 538-8192 
Email: stimberlake@gentuity.com 
 
Gentuity will appoint additional trained clinical research personnel as a point of contact which will be 
communicated to the participating sites throughout the study duration. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title: 
Vis-Rx Prime Micro-Imaging 
Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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Revision: 
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1.4 
Synopsis of the Evaluation 
 
Study Title 
Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study (Vis-Rx Prime 
Clinical Study) 
Product 
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter 
Indications for Use 
The Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) Imaging 
System with Vis-Rx Prime Micro-Imaging Catheter is intended for intravascular 
imaging and is indicated for use in coronary arteries in patients who are candidates 
for PCI. The Vis-Rx Prime Micro-Imaging Catheter is intended for use in vessels 1.3 
to 6.0 mm in diameter. The Vis-Rx Prime Micro- Imaging Catheter is not intended for 
use in a target vessel that has undergone a previous bypass procedure. 
Study Aim 
This clinical evaluation is to assess the performance of the Gentuity HF-OCT 
Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world 
setting. 
Study Objectives 
To evaluate the clinical and technical performance in the target patient population. 
Clinical performance will be determined by interventional cardiologist operator 
evaluation and technical performance will be determined by an objective 
measurement of HF-OCT image clarity. Safety will be evaluated based on reported 
adverse event rates. 
Study Design 
This is a single arm, unblinded, multi-center, clinical evaluation that will be performed 
at 3 to 5 investigational sites in the United States with subjects who undergo HF- 
OCT imaging as part of their cardiac catheterization procedure. This study will 
evaluate a range of device operators (interventional cardiologists) as well as patients 
and vessels consistent with the product labeling. 
The operator evaluation will be determined post use of the device using a Likert 
Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured 
by an independent core lab. 
Safety will be monitored through the interventional procedure and Adverse Events 
that are potentially related to either the device or the procedure will be recorded, 
evaluated and analyzed. Device malfunctions will also be handled according to the 
Gentuity Complaint Handling Process. 
Study Population 
Patients in the cardiac catheterization lab who are candidates for PCI. 
Investigative Sites 
3 to 5 centers in the United States 
Sample Size 
30 to 70 imaged subjects 

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Title: 
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Catheter Clinical Evaluation Study 
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Clinical Performance 
Endpoint 
The performance endpoint includes the following four categories: 
 Catheter preparation 
 Catheter deliverability 
 Image quality 
 Overall performance 
Data collected at the end of each procedure. The criteria will be graded on a 5-point 
Likert Scale with the objective of a mean score of greater than 3 for each category, 
where 3 is acceptable. 
Safety Endpoint 
Safety will be determined based on adverse event data. The primary endpoint for 
safety is the incidence rate for each HF-OCT Imaging procedure related adverse 
event observed in the study. The overall rate and severity of adverse events will be 
analyzed based on the total number of catheters used for the HF-OCT procedures 
performed. 
Technical Endpoint 
A median Clear Image Length for the acquired HF-OCT pullback images greater 
than 35 mm, as evaluated by an independent core lab.  
Inclusion Criteria 
The evaluation inclusion criteria are aligned with the Instructions for Use and include: 
 Patients 18 years of age or older 
 Patients willing and able to provide written informed consent to participate in 
evaluation 
 Patients who are candidates for transluminal interventional procedures for their 
coronary arteries (also known as PCI) 
Exclusion Criteria 
All exclusion criteria align with the Instructions for Use contraindications, and include 
patients who have the following conditions: 
 Bacteremia or sepsis 
 Major coagulation system abnormalities 
 Severe hemodynamic instability or shock 
 Acute renal failure 
 Disqualified for Coronary Artery Bypass Graft surgery 
 Disqualified for Percutaneous Coronary Intervention 
 Patients currently enrolled in another study to evaluate an investigational device or 
medication 
 Any target vessel which has undergone a bypass procedure 
The lesion-specific exclusion criteria assessed from angiography are: 
 Total occlusion 
 Coronary artery spasm 
 Large thrombus (as visible under angiography) 
Follow Up 
Procedure/Visit 
No further subject follow-up assessments or visits are required following the 
transluminal interventional procedure. 

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Title: 
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Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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2 
Devices 
2.1 
Intracoronary Optical Coherence Tomography (HF-OCT) Imaging 
Patients who suffer from Coronary Artery Disease (CAD) might undergo Percutaneous Coronary 
Intervention (PCI) procedures as a means to assess their atherosclerotic lesions and treat the severe 
blockages that reduce the supply of oxygenated blood to the myocardial muscle of the heart. PCI 
procedures are guided by angiography, but this approach is limited because it depicts a 2-D projection 
of the arterial lumen (‘shadow-gram’) with low resolution (~100-200 µm) without providing detailed 
information on three-dimensional vessel morphology including features such as atherosclerotic 
plaques, calcium deposits, vessel trauma, and other similar findings. Intravascular imaging has been 
developed to overcome the limitations of angiography and includes video angioscopy, intravascular 
ultrasound (IVUS), and intravascular optical coherence tomography (HF-OCT). 
HF-OCT is an imaging modality that is analogous to ultrasound imaging but uses near-infrared light 
instead of sound waves. It is estimated that over 100,000 HF-OCT imaging procedures are now 
performed each year in the coronaries1. Extensive clinical data has been acquired on the current HF- 
OCT platforms that indicates adequate safety, efficacy, and value in obtaining the HF-OCT images for 
coronary disease evaluation and treatment planning2. 
Coronary HF-OCT systems use a broad-bandwidth light source with a central wavelength of ~1300 nm, 
where the bandwidth provides the high resolution afforded by HF-OCT (typically 10-20 µm) and the 
central wavelength is chosen to minimize light scattering and increase imaging depth into tissue. It is 
also non-ionizing and low power (a few milliwatts) and therefore inherently safe for tissue exposure. 
Similar to IVUS and even radar, HF-OCT obtains depth (ranging) information by measuring the time-of- 
flight of the reflected signal from the vessel wall and surrounding tissue. Optical coherence tomography 
improves localization of the returned signal due to the much shorter wavelength of the imaging light 
when compared to ultrasound wavelengths and provides resolutions approximately an order of 
magnitude better than ultrasound. 
Coronary HF-OCT catheters use a rotating fiber optic core with attached distal optics, all encased 
within a miniature cross-section, elongated sheath. The distal most section of the sheath is transparent 
for optimal light transmission and collection. The optical catheter collects and returns light scattered 
from the coronary tissue to the HF-OCT system which then analyzes the returned light to create the 
three-dimensional image. Coronary HF-OCT imaging is usually performed with a coinciding delivery of 
contrast media to the target vessel to temporarily displace the obscuring blood from the imaging field. 
HF-OCT imaging runs (‘pullbacks’) are typically completed within 1-3 seconds and cause little or no 
patient discomfort. 
 
The Gentuity HF-OCT console and Vis-Rx Prime Catheter are shown in Figure 1 and Figure 2. 

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Title: 
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Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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Figure 1: Gentuity HF-OCT console, including PIM. 
 
ID 
Name of Component 
Description and Features 
1 
Monitor, 24 inches 
Primary image display for sterile operator. 
2 
Monitor, Touchscreen, 
15.6 inches 
Primary image and interface display for the non-sterile operator. 
3 
Front Handle 
Integrated front handle for transporting the system and for table-side 
positioning. 
4 
Keyboard 
Standard keyboard for data entry. 
5 
USB port 
Used for exporting patient data from the system to a USB drive for storage 
and archiving. 
6 
On/Standby button 
Used to turn the system on or place in standby mode. 
7 
Mouse 
Pointing and selecting device. 
8 
Input/Output 
Video, USB, Ethernet, other I/O. 
9 
Rear Handle/PIM Cable 
Wrap 
Integrated rear handle for transporting the system and PIM cable storage for 
transport. 
10 
Probe Interface Module 
(PIM) 
Bedside connection to catheter. Contains bed rail mount, Start/Stop buttons, 
catheter pull-back drive and catheter rotation drive. 

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Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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11 
Access Cover and 
Power Cord Wrap 
Provides protection for and access to internal components. Contains cooling 
fan. Also provides storage space for AC power cable during transport. 
12 
Power 
Switched and fused AC mains power inlet and grounding terminal (POAG). 
13 
Caster 
High quality medical casters with wheel locks for mobile transport and fine 
positioning. 
Key Internal Components 
Optical Engine Assembly 
Contains the Swept Source, reference arm, detector, and visible red aiming 
beam. 
Computer Assembly 
Contains the system medical grade power supply, mother board, processor, 
memory, mass storage, digitizer, frame grabber and graphic processing unit. 

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– Clinical Investigation Plan 
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Figure 2: Vis-Rx Prime Catheter 
 
 
2.2 
Gentuity HF-OCT Imaging System 
The Gentuity HF-OCT console and Vis-Rx Prime Catheter are shown in Figure 1 and Figure 2. 
The Gentuity HF-OCT Imaging System with Vis-Rx Prime Micro-Imaging Catheter consists of a cart- 
mounted computer and optical engine placed inside an ergonomically designed mobile console. It 
includes two monitors, keyboard, mouse, and cord storage as well as external interfaces to the system. 
It also includes the Probe Interface Module (PIM), which provides the interconnection between the 

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Title: 
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Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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Gentuity System and the Vis-Rx Prime catheter. The cart is equipped with two display monitors: one for 
the console operator (Touchscreen 15.6”), and the other for the physician (24”). 
The Vis-Rx Prime Micro-Imaging Catheter is the next generation of the FDA-cleared Vis-Rx Catheter 
operating on the same Gentuity Imaging System. Both catheters share the same Indications for Use 
Statement and intent-to-treat population as well as a similar design and manufacturing process. The 
Vis-Rx Prime Catheter includes a modified catheter tip design to improve the deliverability of the 
catheter by reducing potential friction. The new rapid exchange tip is also intended to ensure smooth 
deliverability over the guidewire. 
The single-use Vis-Rx Prime Micro-Imaging Catheter (See Figure 2) attaches to the PIM. The catheter 
uses a rotating fiber optic core with attached distal optics (i.e., imaging lens), all encased within a 
miniature cross-section, elongated plastic sheath. The distal most section of the sheath is transparent, 
allowing for optimal near-infrared light transmission and collection. During image acquisition the lens is 
rotated and retracted within the outer sheath to create a longitudinal vessel image volume. Contrast 
media is delivered to the target vessel to temporarily displace the obscuring blood from the imaging 
field during the image acquisition. The HF-OCT imaging runs (pullbacks) are completed within 1 or 2 
seconds. 
During the image acquisition period the lens is rotated and retracted within the outer sheath to create a 
longitudinal vessel image volume. The imaging frame rate that can be achieved is determined by the 
rotational speed of the imaging core as well as by the A-line rate. 

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Title: 
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Catheter Clinical Evaluation Study 
– Clinical Investigation Plan 
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2.3 
Scope of the Evaluation 
The devices under evaluation will be the Gentuity HF-OCT Imaging System and the next generation 
Vis-Rx Prime Catheter (collectively called the ‘Gentuity Device’). 
The interventional cardiology procedure for this clinical evaluation will involve cardiac catheterization, 
with a planned PCI to treat an atherosclerotic lesion per hospital site standard-of-care and the 
discretion of the interventional cardiologist user or operator. The PCI will begin with the standard-of-
care diagnostic angiography and allow for use of any other intravascular imaging or lesion assessment 
according to the standard PCI clinical assessment and treatment decisions. The interventional 
cardiologist can utilize the Gentuity Device according to their device labeling and as it aligns with 
established clinical guidelines for intracoronary imaging throughout the course of the PCI procedure. 
3 
Justification of the Evaluation 
The Gentuity Device improves upon existing intravascular HF-OCT systems by offering a smaller 
catheter which is able to access and image coronary arteries both pre- and post-intervention. It 
captures up to 100 mm of vessel segment in a single one- or two-second pullback. 
Gentuity has designed the next generation Vis-Rx Prime Catheter to reduce the manufacturing and 
material costs associated with the Vis-Rx Catheter. Additionally, minor changes to its design have been 
implemented including a modified catheter tip design that will improve the deliverability of the catheter 
by reducing potential friction. 
With the introduction of the Vis-Rx Prime Catheter, the purpose of this study is to collect clinical data for 
the Gentuity Device that can be used to support a future product regulatory submission in Europe. 
Although the Vis-Rx Prime Catheter has not been reviewed by the FDA, in the United States, FDA does 
not require clinical data as part of the product 510(k) Premarket Notification review process. The 
Gentuity Imaging System that will be used under this investigation plan is the same product that is FDA 
cleared. There are no modifications to the cleared Gentuity Imaging System. 
4 
Risks and Benefits 
4.1 
Benefits 
The subjects who participate in the clinical evaluation may potentially benefit from more thorough 
atherosclerotic lesion assessment during their PCI treatment procedure using intracoronary HF-OCT 
imaging to evaluate their lesion. While intracoronary HF-OCT imaging is used routinely in select 
standard-of-care PCI procedures, it is not used in all PCIs. 
Overall, advancement of medical and scientific knowledge that may benefit future or repeat patients 
may be realized from this evaluation. 
4.2 
Risks 
The standard-of-care PCI procedure introduces certain risks to the patient, and any intravascular 
imaging technology utilized during PCI also carries certain risks. The risks to patients who undergo 
intracoronary HF-OCT imaging with the Gentuity HF-OCT Imaging System and Vis-Rx Prime Micro- 
Imaging Catheter can be found in the instructions for use and are similar to those of other available 

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intracoronary HF-OCT imaging platforms. 
5 
Objectives of the Evaluation 
The aim of this clinical evaluation is to assess the performance of the Gentuity HF-OCT Imaging 
System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting. The objective is to 
evaluate the clinical and technical performance in the target patient population. 
This evaluation will collect safety and performance data for the system in a real-world clinical setting in 
patients who are candidates for PCI, including coronary angiography images and HF-OCT imaging 
both pre- and post-intervention. To objectively evaluate the performance of the Gentuity system, clear 
image length will be determined by an independent core lab experienced in reading HF-OCT 
intravascular images. The target median clear image length is based on a meta-analysis of 64 
randomized controlled trials that found an average coronary lesion length of 17 ± 4 mm3,4. The target 
clear image length includes two standard deviations above the average coronary lesion length, plus 
two 5 mm “landing zones”, one proximal and one distal to the stent, which should provide ample margin 
to image the full target lesion and demonstrate efficacy of the technology. Further, the performance of 
the Gentuity HF-OCT products will be rated by clinicians experienced with using other HF-OCT imaging 
technologies to guide PCI procedures. The evaluation results will be used by Gentuity to prepare for its 
wider clinical use, and to support further regulatory approvals. 
5.1 
Clinical Performance Endpoint 
Clinical performance will be determined by the interventional cardiologist clinical operator based on a 5- 
point Likert-scale rating evaluation following each PCI case. The rating evaluation includes the following 
four categories, with individually scored criteria as listed, which are consistent with the Vis-Rx Prime 
Catheter product specifications: 
Category 1, Preparation: 
 Ease of handling product packaging. 
 Ease of making PIM-catheter connection. 
 Ease of purging. 
Category 2, Deliverability: 
 Ease of loading onto the guidewire. 
 Ease of navigation to imaging region. 
 Visibility of radiopaque markers. 
 Ease of withdrawal over guidewire. 
Category 3, Image Quality: 
 Lumen visualization. 
 Stent visualization. 
 Overall image quality. 

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Category 4, Overall Performance: 
 Image acquisition workflow (pullback). 
 Console screen layout. 
 Overall ability to visualize and assess acquired images. 
The above criteria will be graded on the following 5-point Likert Scale as evaluated by the interventional 
cardiologist clinical operator: 
5: Excellent; 4: Good; 3: Acceptable; 2: Poor; 1: Unacceptable. 
The objective is a mean score above 3 for each of the four categories defined above. 
5.2 
Technical Performance Endpoint 
Technical performance will be determined by an objective measurement of image clarity performed on 
the acquired HF-OCT pullback images by an independent core lab following the PCI case. The 
technical endpoint is the length measurement of image clarity in each pullback, known as the Clear 
Image Length (CIL, in millimeters). The objective is that pullbacks acquired in this evaluation have a 
median CIL greater than 35 mm. 
The 35 mm target CIL arises from the following factors: 
1. Average lesion length: 
The average atherosclerotic lesion length is 17 mm, with a standard deviation of 4 mm per the 
citations3,4, which included an analysis of over 100,000 patients. 
2. Standard deviation of lesion length: 
Two standard deviations (8 mm) have been added to the average lesion length to account for 
98% of the lesions likely to be imaged using HF-OCT in the enrolled subject population. 
3. Landing zones: 
Intracoronary imaging convention for PCI procedures involves imaging “landing zones” or 
“reference segments” of healthy vessel distal and proximal to the target atherosclerotic lesion 
prior to treating with stent implantation. The assessment and measurements performed on 
these 5 mm long landing zones often help determine the size of the stent implanted in the 
lesion. Therefore, the goal is to acquire a clear image of both the distal and proximal landing 
zones in the HF-OCT pullback image. 
4. Calculation of CIL objective: 
17 mm + 2*(4 mm standard deviation) + 2*(5 mm landing zone) = 35 mm. 
Participating subjects are anticipated to have an average of 1.6 implanted stents per the meta-analysis 
cited previously3. Key results from this meta-analysis are excerpted: 
 Angiographic features of included patients 150 arms with 102,735 patients. 
 Length of lesion in mm (median ± SD) 17 ± 4. 
 Number of stents for patients (median, min–max) 1.6 (1–2). 
Participating clinical operators might use the Gentuity HF-OCT imaging technology to assess more than 
one atherosclerotic lesion in participating subjects, thereby imaging more lesions or vessels with HF- 

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OCT than there are subjects enrolled in this evaluation. Furthermore, each lesion can be imaged with 
HF-OCT multiple times throughout the PCI procedure, beginning with pre-intervention to visualize the 
lesion characteristics, later post-intervention following stent deployment to assess stent expansion and 
determine if stent struts are well-apposed to the vessel wall, and to determine if further stent expansion 
is necessary. The number of HF-OCT pullbacks performed in an eligible lesion is at the discretion of the 
operator and in consideration of intravascular imaging guidelines. It is therefore expected that this 
evaluation will collect more HF-OCT pullback images than enrolled subjects. This will provide an 
adequate sample of HF-OCT pullback images for CIL statistical analysis in the target patient population 
(Section 7.2). 
Following the conclusion of each PCI case, the acquired HF-OCT pullback images will be anonymized 
and transferred to an independent core lab experienced in analysis of clinical intracoronary HF-OCT 
pullback images. The core lab will analyze each HF-OCT pullback according to pre-determined criteria 
for image clarity, and each pullback will receive a CIL score. 
5.3 Safety Endpoint 
Safety will be determined based on adverse event data. The primary endpoint for safety is the 
incidence rate for each HF-OCT Imaging procedure related adverse event observed in the study. The 
overall rate and severity of adverse events will be analyzed based on the total number of catheters 
used for the HF-OCT procedures performed. Design of the Evaluation 
5.4 
General 
This is a prospective, single-arm, unblinded, multi-center clinical evaluation assessing the safety and 
imaging capabilities of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System 
and the Vis-Rx Prime Micro-Imaging Catheter for use in PCI procedures. 
The evaluation will be conducted at 3 to 5 centers and will enroll between 30 and 70 subjects who will 
undergo HF-OCT imaging. A conservative estimate of the number of achieved pullbacks was used to 
test the robustness of the statistical model. In this case, each subject is expected to yield 1.3 imaging 
pullbacks during the PCI procedure (as compared with an expected mean of 1.6 stents per patient from 
Section 5.2), for an expected total of at least 39 HF-OCT imaging pullbacks in the evaluation. The 
sample will reflect a range of clinical operators as well as patients and vessels consistent with the 
labeling for the device. 
The clinical performance endpoint is the 5-point Likert scale rating by the interventional cardiologist 
clinical operator following each PCI case. The objective is a mean rating of greater than 3 for each of 
the four categories, where 3 is considered acceptable. Refer to section 5.1 for further details of the 
clinical performance evaluation. 
The technical performance primary endpoint is that the acquired HF-OCT pullback images have a 
median Clear Image Length (CIL) of greater than 35 mm, as measured by an independent core lab 
experienced in analysis of intracoronary HF-OCT images. The target of 35 mm CIL is based on the 

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average and standard deviation of atherosclerotic lesion length and the convention of imaging a distal 
and proximal landing zone that serves as a reference of the neighboring healthy vessel. 
5.5 
Devices 
The Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) Imaging System Console and 
the Vis-Rx Prime Micro-Imaging Catheter are the devices subject to evaluation. Please, refer to Section 
2.2 of this evaluation protocol for further details. There are no comparator or control devices in this 
evaluation. Other medical devices may be used as part of PCI standard-of-care at the discretion of the 
interventional cardiologist clinical operator, including guidewires, stents, angioplasty balloons, etc.; 
none of these devices shall be investigational or involved in another clinical study or evaluation. 
5.6 
Subjects 
In general, this evaluation is intended to enroll “all comers” for standard-of-care PCI treatment 
procedures who also meet the Indications for Use for the Gentuity HF-HF-OCT Imaging System and 
Vis-Rx Prime Micro-Imaging Catheter at the participating centers during the time of subject screening 
and enrollment. The subjects eligible for enrollment and participation in this clinical evaluation are those 
that meet all the below inclusion criteria, none of the below exclusion criteria, and who provide written 
informed consent for participation prior to their PCI procedure. The evaluation inclusion and exclusion 
criteria are aligned with the cleared Indications for Use, repeated here: 
The Gentuity HF-OCT Imaging System with Vis-Rx Prime Micro-Imaging Catheter is intended for 
intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for 
transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is intended for use in 
vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is not intended for use in 
a target vessel that has undergone a previous bypass procedure. 
5.6.1 Inclusion Criteria 
The subjects who are screened and enrolled should meet all the following inclusion criteria: 
 Patients 18 years of age, or older. 
 Patients willing and able to provide written informed consent to participate in evaluation. 
 Patients who are candidates for transluminal interventional procedures for their coronary 
arteries (also known as PCI). 
5.6.2 Exclusion Criteria 
The subjects who are screened and enrolled should have none of the conditions, history, or anatomy as 
described in the following general exclusion criteria, which are contraindications of the Gentuity HF- 
OCT Imaging System and Vis-Rx Prime Micro-Imaging Catheter according to the instructions for use. 
 Bacteremia or sepsis. 
 Major coagulation system abnormalities. 
 Severe hemodynamic instability or shock. 
 Acute renal failure. 

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 Disqualified for Coronary Artery Bypass Graft (CABG) surgery. 
 Disqualified for PCI procedure. 
 Patients currently enrolled in another study to evaluate an investigational device or medication. 
 Any target vessel which has undergone a bypass procedure. 
 
 
5.6.2.1 Lesion-specific exclusion criteria 
Enrolled subjects will be screened for lesion-specific exclusion criteria during the PCI procedure using 
diagnostic angiography. Subjects that undergo HF-OCT imaging and target atherosclerotic lesions that 
are imaged should have none of the following lesion-specific conditions or anatomy, which are 
contraindications of the Gentuity HF-OCT Imaging System and Vis-Rx Prime Micro-Imaging Catheter 
according to the Instructions for Use. 
 
Total occlusion. 
 
Coronary artery spasm. 
 
Large thrombus (as visible under angiography). 
 
 
 
Figure 3: Participating subject procedural flow chart, from informed consent through study 
exit, including post-PCI data collection and image analysis. 

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5.6.3 Duration of Participation 
Each participating subject is expected to be in the evaluation from the time of providing written informed 
consent through the course of their PCI procedure. Details on the point of enrollment, evaluation exit, 
and withdrawal are all described in the sections below. The progression of a subject’s participation in 
the evaluation is shown in the flow chart described in Figure 3. 
5.6.4 Point of enrollment 
Patients will be considered enrolled in this clinical evaluation if – 
a) Written informed consent has been obtained, AND 
b) The patient meets all the inclusion criteria, none of the general exclusion criteria and none of the 
lesion-specific exclusion criteria after diagnostic angiography. 
Patients that do not qualify for the study based on the inclusion/exclusion criteria will be considered 
screen failures. 
5.6.5 Primary Analysis Population 
Several exclusion criteria apply to characteristics of the target lesion(s) which can only be assessed 
and confirmed during the PCI following the diagnostic angiography. Only subjects who undergo HF- 
OCT imaging will be included in the Primary Analysis Population. The start of the HF-OCT imaging 
procedure is considered the introduction of the Vis-Rx Prime Imaging Catheter into the hemostatic 
valve which corresponds to its insertion into the subject’s bloodstream. 
Any patient that is consented and screened, but who does not undergo the HF-OCT imaging 
procedure, will not be included in the Primary Analysis Population. 
The evaluation will include between 30 and 70 HF-OCT imaged subjects in the Primary Analysis 
Population. 
5.6.6 Evaluation exit 
Subjects are exited from the evaluation following the completion of their PCI. There are no follow-up 
assessments or visits. 
5.6.7 Withdrawal 
Subjects can voluntarily withdraw from the screening process or discontinue the evaluation at any time 
during their participation, which begins following written informed consent and continues until the 
completion of their PCI procedure. 
The clinical operator can also decide to withdraw a subject from the evaluation if he or she determines 
that it is in the best interest of the subject to cease participation. 

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5.7 
Procedures 
The use of the Gentuity HF-OCT imaging technology in this clinical evaluation is intended to align with 
the standard-of-care use of other intracoronary imaging technologies, including other available HF-OCT 
imaging platforms and IVUS as well. Gentuity HF-OCT imaging can be used at various times during the 
typical PCI procedure to assess or visualize the atherosclerotic lesion or the administered interventional 
treatment such as a coronary stent. The use of other FDA-cleared intravascular lesion assessment 
technology, such as Fractional Flow Reserve (FFR) for physiological analysis, is not restricted. 
5.6.8 HF-OCT Imaging Steps 
The steps in the Gentuity HF-OCT imaging procedure include the following: 
1. Preparation of the HF-OCT System Console according to the User Manual. 
2. Selection of pullback parameters on the HF-OCT System Console. The following are 
recommended for optimal HF-OCT imaging for this study: 
a. Pullback length 100 mm 
b. Flush media: 100% (undiluted) contrast media 
3. Preparation of the Vis-Rx Prime Micro-Imaging Catheter according to the Instructions for Use. 
4. Preparation of contrast media flush according to the Instructions for Use. 
5. Positioning the Vis-Rx Prime lens marker distal to the target lesion in order to acquire an HF- 
OCT pullback image of the distal landing zone, the target lesion, and the proximal landing zone. 
6. Administration of contrast media flush to clear blood from lesion during image acquisition. 
7. Initiation of the imaging pullback when blood clearance is obtained and subsequent image 
acquisition. 
8. Post-acquisition image playback and review for lesion assessment and measurements. 
Following the PCI procedure, the interventional cardiologist operator will complete the Likert-scale 
performance assessment to provide product feedback. 
6 
Statistical Analysis Plan 
6.1 
Introduction 
The study features a prospective, single arm, unblinded, multi-center design. The study will enroll 
between 30 and 70 subjects who will undergo HF-OCT imaging at 3-5 participating centers. The 
objective of this study is to evaluate the clinical and technical performance in the target patient 
population. The clinical performance will be measured by the operator’s subjective evaluations of 
catheter preparation, catheter deliverability, overall catheter ease of use, and image quality. The 
technical performance will be measured by an objective measurement of the length of clarity in each 
HF-OCT pullback or Clear Image Length (CIL, in millimeters). 
The Gentuity HF-OCT can capture up to 100 mm of vessel segment in a single pullback. The study’s 
primary hypothesis states that the true population median CIL is greater than the reference standard of 

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35 mm, such that a one-sample comparison of median to a reference CIL standard or µ0 can be 
expressed as the following: 
H0: µ = µ0 vs. H1: µ ≠ µ0, where µ0 = 35 mm was chosen per the analysis of Section 5.2 
The test will be accomplished by a one-sample two-sided exact Wilcoxon signed-rank test with 0.05 
type I error rate. The data support µ > µ0 if the two-sided p-value is less than 0.05 and the estimate of µ 
is greater than µ0. 
For all enrolled subjects who are included in the Primary Analysis Population, clinical data, and 
collected HF-OCT images will be retained and analyzed for technical performance. For subjects who 
were consented and enrolled but who were screening failures during the PCI procedure via lesion- 
specific exclusion criteria, any clinical data collected prior to PCI will not be included in the evaluation 
demographic, medical history, or PCI details analyses. 
For all enrolled subjects and cases that involve HF-OCT imaging, the clinical operator will be 
interviewed to evaluate the Gentuity HF-OCT technology for its clinical performance in catheter 
preparation, catheter deliverability, image quality, and overall performance. 
The following sections describe the plans for statistical analysis of the evaluation results. The statistical 
analysis plan is based on the minimum enrollment into the Primary Analysis Population, which is 30 
subjects. 
6.2 
Sample Size Calculation 
The study plans to enroll and image at least 30 subjects with the HF-OCT imaging technology, and up 
to 70 subjects. Conservatively, each participating subject is expected to have an average of 1.3 
imaging pullbacks, for an anticipated total of approximately 39 imaging pullbacks (or more) captured 
with HF-OCT in the evaluation. The number of HF-OCT pullbacks performed in an eligible lesion is 
according to the discretion of the operator and in consideration of intravascular imaging guidelines. It is 
therefore expected that this evaluation will collect at least 39 HF-OCT pullback images. For the purpose 
of power calculation, we assume that 39 HF-OCT pullback images will be obtained from the minimum 
of 30 subjects. Another reasonable assumption to make in this case is that these 39 pullback images 
are statistically independent. The argument for statistical independence lies in the fact that CIL is very 
dependent on the details of the artery shape, the local flow, and the positioning of the guide catheter 
which delivers the flush. These factors yield a great deal of variability in the resulting CIL 
measurements even among vessels from the same subject. 
The power analysis was performed using SAS/STAT PROC POWER and mean-based paired t-test, 
while the actual analysis will be median, or rank based due to abnormality in the skewed CIL data 
distribution. To compensate for the methodology difference, a Wilcoxon adjustment factor was applied. 
This adjustment factor to the sample size is based on an assumed data distribution5. The adjusted 
sample size NW is equal to: NW = NT/𝑊𝑊𝑊𝑊, where NT is the unadjusted sample size using the paired t-test 
and 𝑊𝑊𝑊𝑊 is the Wilcoxon adjustment factor for the assumed data distribution and has a range between 
2/3 and π/3. A conservative decision was made to use the adjustment factor resulting in the largest 
adjusted sample size NW. 

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The Gentuity HF-OCT technology is designed with a longer, 100 mm pullback length. It is expected that 
about 20% of the pullbacks will be in the 75 mm range. Setting the expected mean CIL at 45 mm and a 
target reference CIL of 35 mm (corresponding to an effect size 10 mm), standard deviation of 17 mm, 
5% type 1 error rate, a study with 38 vessels will provide more than 80% power for the above 
hypothesis testing6. 
Table 1: Various effect size, standard deviation, and sample size to attain approximately 80% power. 
 
Effect Size 
∆ = µ - µ0 
SD in ∆ 
Unadjusted 
Sample Size (NT) 
Adjusted Sample 
Size (Nw) 
Power 
6 
10 
24 
36 
80.4% 
7 
12 
27 
40 
81.6% 
8 
14 
27 
40 
81.5% 
9 
16 
27 
40 
80.3% 
10 
17 
25 
38 
80.6% 
11 
19 
26 
39 
81.0% 
12 
21 
27 
40 
81.5% 
 
6.3 
Remarks About Statistical Analysis 
All the analyses will be performed using SAS statistical software, version 9.4 or higher, primarily PROC 
FREQ for categorical data and PROC UNIVARIATE for continuous data. For categorical variables, 
subject counts and percentages will be generated. For continuous variables, mean, standard deviation, 
median and range will be generated. Two-sided p-values of less than 0.05 will be considered as 
statistically significant. Analyses will be based on the observed data only. Missing data will not be 
imputed. Multiple comparison adjustment will not be performed. 
6.4 
Baseline Analysis 
Subject demographic variables will be summarized descriptively. Medical history findings and PCI 
details will be tabulated. Protocol deviations will be listed. 
6.5 
Clinical Performance Analysis 
The performance endpoints consist of the following four previously identified categories (Section 5.1): 
 Catheter preparation 
 Catheter deliverability 
 Image quality 
 Overall performance 
Subjective criteria within these categories will be evaluated and rated using the 5-point Likert scale by 
the interventional cardiologist clinical operator. The performance endpoints will be analyzed by mean 
and standard deviation. As the Likert scale evaluation will be conducted following the PCI case of each 
enrolled subject, the performance evaluation sample will be equivalent to the number of enrolled 

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subjects who underwent HF-OCT imaging. The primary performance objective is to achieve a mean 
rating of greater than 3 (or acceptable) for the above four categories. No inferential statistical analysis 
will be performed for these clinical performance endpoints. 
Three (3) to five (5) centers will enroll subjects, and there may be multiple interventional cardiologist 
clinical operators at each participating center. Therefore, there will be a range of clinical operators who 
evaluate the performance of the Gentuity HF-OCT Imaging System and Vis-Rx Prime Catheter in a 
range of PCI cases. 
6.6 
Technical Performance Analysis 
The clear image length analysis will be conducted on HF-OCT pullbacks acquired in this evaluation by 
an independent core lab experienced with intracoronary HF-OCT imaging analysis. A clear image 
frame has at least 270° of visible lumen. CIL is the extent of clear image frames in a given pullback, 
measured in millimeters. The acquired pullbacks will reflect a range of coronary arteries, atherosclerotic 
lesions, and procedural timepoints. These factors result in a great deal of variability in the CIL 
measurements even among pullbacks from the same subject. Consequently, for these CIL data, it is 
reasonable to utilize statistical methodologies normally suitable only for independent observations. The 
primary analysis will be performed using SAS/STAT PROC UNIVARIATE and features an exact one- 
sample two-sided Wilcoxon signed-rank test using “CIL minus 35” as outcome. The data will reject the 
null hypothesis and support Gentuity HF-OCT’s claim of superiority to the reference standard if the two- 
sided p-value is less than 0.05 and the median CIL estimate greater than 35 mm. 
6.7 
Safety Endpoint Analysis 
Safety endpoint analysis will be determined based on adverse event data. The primary endpoint for 
safety is the incidence rate for each HF-OCT Imaging procedure related adverse event observed in the 
study. The overall rate and severity of adverse events will be analyzed and reported as a percentage 
based on the total number of catheters used for the HF-OCT procedures performed. 
6.8 
Procedural Error and Device Malfunctions 
It is possible that a procedural error may occur that will lead to a pullback image being captured that 
has no or only partial clear imaging. For example, the injector pump (if used) had insufficient contrast 
media to clear the vessel, the bedside manifold was set such that delivered contrast media was not 
directed into the guide catheter and vessel, or the guide catheter became mis-aligned with the target 
artery prior to flush delivery. If such errors occur, they will be noted in the Case Report Form, the HF- 
OCT pullback will be repeated (at the operator’s discretion), and the pullback with the procedural error 
will not be included in the statistical analysis. Any procedural errors will be described in the final report. 
The investigational device malfunctions will be recorded and detailed on the Device Malfunction Case 
Report Form. Document malfunctions that occur at setup and during use of the device will be 
collected.  
 
 

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7 
Data Management 
The collection and handling of subject clinical data will comply with regulatory guidelines and the 
Sponsor’s Standard Operating Procedures (SOPs). All steps and actions taken regarding data 
management and quality assurance will be documented in the Sponsor’s SOPs and data management 
plan. 
Subject demographic, medical history, PCI details, and the Likert-scale performance evaluation will be 
collected via paper Case Report Forms (CRFs). The clinical data will be reviewed and approved by the 
clinical operator following the PCI and performance evaluation interview. The CRFs will collect only de- 
identified information. The data will be identified using methods to ensure HIPAA compliance (e.g., 
study participant ID). Following the PCI, clinical performance evaluation, and completion and approval 
of the CRFs, the collected data, including HF-OCT and coronary angiography images, will be 
transferred to Gentuity for data monitoring and clinical performance analysis.  
HF-OCT images will be exported from the Gentuity HF-HF-OCT Imaging System Console in an 
anonymized format onto a USB drive. The anonymized HF-OCT image files will be transferred in a 21 
CFR Part 11 compliant manner from the participating center to the core lab for later CIL image analysis. 
In addition, Gentuity will collect an anonymized copy of the pullback images. The CIL technical 
performance results will be entered into a CRF by the core lab and provided to the statistician for 
technical performance results analysis. 
Centers and the core lab are responsible for retaining the primary data and records for this evaluation 
for a period of two years following the close-out of the study. The Sponsor should be contacted prior to 
the destruction of any records pertaining to this evaluation to ensure that they no longer need to be 
retained. 
8 
Amendments to the Evaluation 
Amendments to this clinical evaluation protocol will be identified by protocol number and revision letter. 
All amendments will be accompanied by an addition to the revision history table on the cover page that 
identifies all substantial changes. The protocol reference number and revision letter will be placed on 
the title page and every subsequent page of an amendment. 
A protocol amendment will not be implemented for enrollment of subjects before all necessary reviews 
and approvals have been obtained, including Sponsor approvals, clinical operator signatures, and local 
Institutional Review Board (IRB) approvals, as applicable. 
9 
Deviations from the Evaluation Protocol 
Deviations to the informed consent process, inclusion or exclusion criteria, and evaluation procedures 
including the HF-OCT imaging and clinical performance evaluation will be identified and tracked to 
determine the potential impact on the evaluation results. 
Deviations relating to subject informed consent and deviations resulting in safety events for the subject 
will be reported to the local IRB per their reporting policies. 
 
 

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10 Statements of Compliance 
This evaluation will be conducted in compliance with international ethical and scientific quality standards, 
known as Good Clinical Practice (GCP), which includes review and approval by independent  
Institutional Review Boards (IRBs) before enrolling subjects, continuing review by IRBs, and obtaining 
and documenting informed consent of subjects prior to participation. 
The study was designed to reflect GCP as outlined in International Organization for Standardization 
(ISO) 14155:2011. It will also be conducted in compliance with applicable local and national 
regulations, including FDA regulations (21 CFR Parts 11, 50, 54, and 56). It will furthermore be 
conducted in compliance with the International Council for Harmonization (ICH) Guideline E6 for GCP. 
This clinical evaluation shall not begin until the required approvals are obtained from the applicable 
IRBs. 
Subjects will not be paid to participate in the clinical evaluation. It is not expected that subjects will incur 
any additional cost due to their participation in the evaluation. 
11 Informed Consent Process 
Informed consent must be obtained in accordance with FDA regulations 21 CFR Part 50, 45 CFR Part 
46, and ICH E6 Good Clinical Practice (GCP). 
Each subject must sign and date the current version of the Informed Consent Form (ICF) as approved 
by the IRB prior to screening and enrollment in the evaluation. The subject will be provided with ample 
time and opportunity to ask about the details of the Gentuity HF-OCT devices and evaluation 
procedures in order to decide on whether to participate before informed consent is obtained. Coercion 
or undue influence of a subject for participation must be avoided and a subject’s legal rights must not 
be waived. 
An ICF will be provided to each prospective subject to include: an explanation of the evaluation; the 
expected benefits, risks, or inconveniences to them; an explanation of alternatives; Gentuity 
representative attendance of their PCI; provision of anonymized HF-OCT images to the Sponsor and 
core lab; and collection of de-identified clinical data. The ICF will contain non-technical language. 
Informed consent will be documented by the dated signatures of the subject and the individual 
obtaining informed consent. The clinical operator or designee will be responsible for obtaining informed 
consent. 
12 Adverse Events 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in a clinical evaluation subject, users, or other 
persons, whether or not related to the evaluation device. An AE would be any unfavorable or 
unintended sign, symptom, or disease that appears or worsens during the subject’s participation in this 
evaluation. 
Subject safety will be monitored throughout a subject’s participation in the evaluation, from the 
beginning of the HF-OCT imaging procedure when the Vis-Rx Prime Catheter is inserted into the 
hemostatic valve, and continuing through their exit from the evaluation at the conclusion of the PCI 

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procedure. Any Adverse Events will be assessed by the clinical operator according to their relatedness 
to the Gentuity HF-OCT imaging procedure, Vis-Rx Prime Micro-Imaging Catheter, or HF-OCT Imaging 
System. 
Any observed AE will be documented on the Adverse Event CRF. Any AE deemed to be possibly, 
probably, or definitely related to the Gentuity HF-OCT procedure, Vis-Rx Prime Catheter, or Imaging 
System will be reported to the IRB and evaluated as a complaint by Gentuity per Gentuity’s complaint 
handling process. Non-related AEs will be tracked until the subject exits the evaluation at the 
conclusion of their PCI. Related AEs will be tracked until they are resolved. 
Each AE will be classified as either non-serious or serious. A Serious Adverse Event (SAE) is defined 
to be an AE that: 
 Led to death. 
 Led to serious deterioration in the health of the subject, that either resulted in: 
o A life-threatening illness or injury, or 
o A permanent impairment of a body structure or a body function, or 
o In-patient or prolonged hospitalization, or 
o Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function. 
 Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
Each AE will furthermore be classified as either anticipated or unanticipated. The anticipated AEs are 
listed in the Instructions for Use. Any unanticipated AEs will be further considered to determine if they 
may be an Unanticipated Serious Adverse Device Effect (USADE), which is defined to be a serious 
adverse device effect which by its nature, incidence, severity, or outcome has not been identified in the 
current version of the risk analysis report. 
Adverse events will be reported by diagnosis term, severity, and relatedness to the HF-OCT imaging 
procedure, Vis-Rx Prime Catheter, and HF-OCT Imaging System. Narratives will describe serious 
events and related events. Tabulation of procedure-emergent adverse events will be generated and 
stratified by diagnosis term. Similar tabulations will be generated for procedure or device related AEs 
that are classified as definitely, probably, or possibly related to the evaluation procedure or products. 
 
 

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13 Schedule of Assessments 
  
 
Clinical Test 
Baseline 
Intra-Procedure 
Post-Procedure 
 
Informed Consent 
 
X 
 
 
 
Initial Inclusion/Exclusion Screening 
 
X 
 
 
 
Subject Demographics 
 
X 
 
 
 
Medical History 
 
X 
 
 
Transluminal Interventional 
Procedure History 
X 
 
 
 
Coronary Angiography 
 
 
X 
 
 
Lesion-Specific Screening 
 
 
X 
 
HF-OCT Imaging and Pullback(s) 
Details 
 
X 
 
Transluminal Interventional 
Procedure Details 
 
X 
 
 
Device Malfunction (if applicable) 
 
 
X 
X 
 
Likert-Scale Rating Evaluation 
 
 
 
X 
 
Adverse Event Assessment 
 
 
X 
 
 
HF-OCT Image Upload 
 
 
 
X 
 
Coronary Angiography Upload 
 
 
 
X 
 
Case Report Form Upload 
 
 
 
X 

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14 Revision History 
 
Revision 
ECO # 
Date 
Description of Change(s) 
A 
E04329 
2/21/2024 
Initial Release 
B 
E04435 
4/19/2024 
The name of the study has been updated to reflect the new 
commercial name for the Micro-Imaging catheter, which was 
changed from ‘GenVue’ to ‘Vis-Rx Prime’. All references to 
‘GenVue’ have been replaced with ‘Vis-Rx Prime’ in the CIP. 
C 
E04709 
11/12/2024 
Section 2.3 removed Arjun Bhat as primary study contact and 
added general statement about Gentuity contact personnel 
information throughout duration of study.  
Section 3.1 updated catheter drawing to reflect one pullback 
marker.  
Sections 6.0 clarified type of imaging to included angiography 
and HF-OCT imaging. 
Section 7.8 added language related to how device malfunction 
data will be collected. 
Section 8.0 added language to clarify collected data to include 
HF-OCT imaging and angiography. 
Section 13 added Schedule of Assessments table.  
Moved revision history from cover page to Section 14 
Bibliography now Section 15 
15 Bibliography 
1 
Swanson, E. A. & Fujimoto, J. G. The ecosystem that powered the translation of OCT from 
fundamental research to clinical and commercial impact [Invited]. Biomedical optics express 8, 
1638-1664, doi:10.1364/BOE.8.001638 (2017). 
2 
van der Sijde, J. N. et al. Safety of optical coherence tomography in daily practice: a comparison 
with intravascular ultrasound. European heart journal cardiovascular Imaging 18, 467-474, 
doi:10.1093/ehjci/jew037 (2017). 
3 
D'Ascenzo, F. et al. Impact of design of coronary stents and length of dual antiplatelet therapies 
on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 
102 735 patients. European heart journal 38, 3160-3172, doi:10.1093/eurheartj/ehx437 (2017). 
4 
Dilmanian, H. et al. The average stent length is longer and the average stent diameter is shorter in 
patients with drug-eluting stents versus bare-metal stents during percutaneous coronary 
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