Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)
Phase: NA
Conditions: Device Malfunction, ICD, Pacemaker Lead Dysfunction
Sponsor: University of Chicago

Study Title: IntravaScular Ultrasound (IVUS) Imaging During 
Transvenous LEad Extraction (ISEE)
NCT Number: NCT04055740
Document Date: October 15, 2021

Version: 2021Oct15 
1 
PROTOCOL TITLE: Intravascular Ultrasound (IVUS) Imaging During Transvenous LEad 
Extraction  (ISEE) 
 
PI: Hemal M. Nayak, MD 
 
CO-I(S): Andrew Beaser, MD 
 
FUNDING Image Guided Therapy Devices business group of Philips Healthcare (collectively, “Philips”) 
comprised of Spectranetics Corporation and Volcano Corporation  
 
SPONSOR: Investigator-Sponsor 
 
TYPE OF RESEARCH: Clinical Trial 
 
INTERVENTION: Intravascular ultrasound (IVUS) imaging conducted during transvenous lead 
extraction (TLE) 
 
MANUFACTURER OF INTERVENTION (if applicable):  
Volcano Corporation 
2870 Kilgore Road 
Rancho Cordova, CA 95670 USA 
 
 
 
 

Version: 2021Oct15 
2 
STUDY SUMMARY 
TITLE 
Intravascular Ultrasound (IVUS) Imaging During Transvenous 
LEad Extraction  (ISEE) 
 
SHORT TITLE 
ISEE 
PROTOCOL NUMBER 
IRB18-1600  
METHODOLOGY 
Clinical Trial  
SAMPLE SIZE 
100 consecutive patients that have been recommended for lead 
extraction, with at least one lead over 1 year dwell time 
STUDY DURATION 
1 year 
STUDY CENTER(S) 
University of Chicago Medicine, Penn Medicine, University 
of Michigan, Allina Health 
OBJECTIVES 
The purpose of this study is to evaluate IVUS as a tool for 
grading the presence of fibrotic adhesions to cardiac 
pacemaker/defibrillator leads during transvenous lead 
extraction (TLE).  
DIAGNOSIS AND MAIN 
INCLUSION CRITERIA 
Subjects that have been recommended for TLE with at least 
one transvenous lead over 1 year dwell time. 
STUDY PRODUCT 
IVUS catheter (Visions® PV.035) 
DURATION OF 
ADMINISTRATION 
For the duration of the TLE procedure 
STATISTICAL 
METHODOLOGY 
Traditional statistical methods will be employed. The 
student’s T-test will be used for continuous comparisons. 
Fisher’s exact or the Chi-square test will be applied for 
dichotomous variables. Spearman correlation coefficients will 
be calculated. 
 
 

Version: 2021Oct15 
3 
LIST OF ABBREVIATIONS 
CIED  
 
 
 
Cardiovascular implantable electronic device 
CXR 
 
 
 
 
Chest x-ray 
ICD 
 
 
 
 
Implantable cardioverter-defibrillator 
ILA 
 
 
 
 
Intravascular lead adherence 
INNV  
 
 
 
Innominate vein 
IVUS  
 
 
 
Intravascular ultrasound 
PA 
 
 
 
 
Postero-anterior 
RA 
 
 
 
 
Right Atrium 
SVC 
 
 
 
 
Superior vena cava 
TV 
 
 
 
 
Tricuspid valve  
TEE 
 
 
 
 
Transesophageal echocardiography 
TLE 
 
 
 
 
Transvenous lead extraction 
 
 
INTRODUCTION 
BACKGROUND AND RATIONALE 
Increased indications for permanent cardiac pacing with biventricular pacing systems and the success of 
implantable cardioverter-defibrillators (ICD) in improving mortality in patients with ventricular 
arrhythmias and chronic systolic heart failure, has resulted in a significant increase in the rate of 
implantation of cardiovascular implantable electronic devices (CIEDs) [1,2]. Unfortunately, there has also 
been a parallel rise in the rate of CIED infection and lead failure or malfunction with subsequent increase 
in the need for transvenous lead extraction (TLE) [1,3]. As outlined in the 2017 Heart Rhythm Society 
(HRS) consensus statement on lead management and extraction, CIED leads should be fully removed in 
the case of system infection (class I indication), and lead removal is suggested in the case of lead 
malfunction, fracture, or recall [4]. Some CIED leads can be removed without locking stylets or powered 
cutting sheaths, and therefore, TLE poses little risk to the patient. However, due to the development of 
fibrosis on the majority of CIED leads especially within sensitive venous and cardiac structures, more 
complex procedures are often necessary, requiring the use of laser sheaths or powered cutters to break the 
lead free from tissue and vascular adhesions. During this procedure, major adverse events can occur that 
can lead to patient morbidity and mortality. The most common mechanical injury during TLE is a tear in 
the superior vena cava (SVC) [5]. Though rare, this complication is often devastating and associated with 
significant morbidity and mortality and almost always requires emergent surgical intervention [4]. A 
common variable associated with this major complication is the presence of significant intravascular lead 
adhesion (ILA) or fibrosis [5].  
Currently it is difficult to predict the locations and severity of ILA within the SVC or right atrium (RA) 
giving physicians a significant disadvantage when entering these procedures. Pre-procedure imaging with 
CXR, CT scan and fluoroscopy have limited utility [6]. While clinical risk factors such as female gender, 
longer lead dwell time, presence of high voltage coil or existence of multiple leads in the vascular space, 

Version: 2021Oct15 
4 
low body mass index (BMI) and younger patient age have all been associated with a greater likelihood of 
ILA, they are not reliable predictors due to the inherent inter-patient variability in the vascular biology 
dictating the development of  ILA [7,8,9,10].  
Phased-array intracardiac echocardiography (ICE) and/or radial-ICE, also known as IVUS, have become 
important imaging tools in electrophysiology (EP) [11].  It is standard of care to use ICE in many EP 
procedures [11]. It helps in performing safe trans-septal puncture, aids in identifying important cardiac 
structures (papillary muscles, pulmonary veins, aortic cusps), and is utilized to monitor for complications 
(pericardial effusion, clot development, steam pops) [11].  
Radial-ICE or IVUS has been utilized during TLE and was found to be a feasible and safe tool to 
visualize leads in a small study of 25 patients.  The authors concluded that radial-ICE evaluation “is safe 
and feasible in patients with pacing and defibrillating leads before and during transvenous lead removal, 
offering an excellent visualization of cardiac leads and related areas of adherence. ICE can assist pacing 
and ICD lead removal and could improve procedure efficacy and safety” [12]. Sadek and colleagues 
evaluated phased array ICE in 50 patients undergoing TLE. The authors concluded that while phased-
array ICE was able to identify areas of binding it was not able to identify binding sites that are high versus 
low risk of requiring complex extraction techniques. In this study, there were no adverse events noted 
with using ICE [13]. Radial ICE or IVUS has a number of advantages over phase- array ICE because it 
can provide a 360° cross-sectional image, allowing better visualization and assessment of ILA.   
At the University of Chicago, IVUS is routinely used during TLE. At first, we used it to monitor for 
complications like the development of pericardial effusion or clots. We quickly realized that it had other 
uses. Under the following IRB protocol #16-0272 titled “Safety and Outcomes of Electrophysiology 
Procedures in the Electrophysiology Laboratory at the University of Chicago: A Prospective Registry for 
Arrhythmia Care”. Dr. Beaser and I reviewed and collected data on 56 patients who had undergone TLE 
where IVUS imaging was performed and ILA was identified and quantified.  We correlated the degree of 
ILA seen on IVUS to metrics reflecting the difficulty of TLE (pulses of laser energy delivered and time 
required to traverse an area of fibrosis or ILA). We found that (1) ILA can be readily visualized, 
accurately quantified using IVUS, (2) The degree of ILA correlates highly with difficulty of extraction as 
measured by the time required to traverse and the amount of laser pulses delivered in each vascular 
segment and (3) IVUS has potential to identify patients who may be at low risk for vascular 
complications in the SVC-RA region during TLE. No additional complications were found by routinely 
using IVUS and we noted that there was an added incremental value to clinical predictors of fibrosis. For 
example, a patient with a low body mass index, a high lead dwell time and a dual coil ICD lead would be 
expected to have a higher amount of ILA based on clinical factors. We found that these factors were not 
reliable. In many cases, IVUS was able to demonstrate minimal ILA, This finding helped guide laser 
sheath use and the need for placing the Philips rescue balloon. In contrast, a patient with risk factors 
predicting low ILA may have IVUS findings indicating the opposite. This type of finding would help in 
determining whether the extraction should be approached from below (femoral work station) or not 
performed using laser (e.g. refer to surgery). Our work was presented in the Philips Imaging Symposium 
in July 2018 in Philadelphia. Our data was very well received by our EP colleagues, and this led us to 
initiating a larger multi-center study to validate our findings.  

Version: 2021Oct15 
5 
Therefore, the purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging 
as a tool for grading the presence and characterization of ILA to cardiovascular implantable electronic 
device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS 
should identify the location and severity of these adhesions, which we will then correlate to difficulty of 
the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse 
an area of fibrosis or ILA. We will be focusing primarily on the section from innominate vein (INNV) 
down through the superior vena cava (SVC) to the right atrium.  
 
Currently, the Visions® PV.035 IVUS catheter is designed for use in the evaluation of vascular 
morphology in blood vessels of the peripheral vasculature [Appendix A]. It is commonly used during 
interventional cardiology and radiology procedures and has a solid safety profile [14-19]. In a large study 
of 227 patients, the Visions® PV.035 IVUS catheter was used to assess pelvic vein insufficiency. There 
were no adverse events related to IVUS imaging [14]. Two other studies of 117 and 104 patients 
respectively, found that imaging with the Visions® PV.035 IVUS catheter was safe and not associated 
with any adverse events [15,16]. Three other studies using the Visions® PV.035 IVUS catheter found 
similar results [17,18,19]. In all of these studies, the Visions® PV.035 IVUS catheter was used to image 
peripheral veins. In our proposed study, we wish to use IVUS to image leads in venous structures (SVC, 
INNV) and the SVC-RA junction. The IVUS catheter will need to be inserted through a sheath inserted in 
the right or left femoral vein and pass through the RA to reach the regions of interest which constitutes an 
“off-label” use of the product. This “off-label” use of the IVUS catheter is standard clinical practice in the 
University of Chicago EP cath lab. There were no adverse events seen with use of IVUS in our cohort of 
56 patients that Drs. Beaser and I studied from the EP registry data. Based on the published literature 
supporting the safety of the Visions® PV.035 IVUS catheter and our own experience, we believe that 
using IVUS for this purpose provides a non-significant risk to patients.  
 
OBJECTIVES 
We hypothesize that:  
IVUS imaging will provide incremental value beyond clinical factors in identifying vascular adherence  
Specific Aims: 
Aim 1: Experienced operators at 5 major lead management medical centers will be able to image 
ILA using IVUS during TLE 
Aim 2: ILA will be correlated to metrics of TLE difficulty  
Aim 3: The incremental value of IVUS will be assessed systematically in identifying patients at 
low risk of developing a vascular tear in the SVC-RA region 
 

Version: 2021Oct15 
6 
PRIMARY ENDPOINTS 
 
1. Ability of IVUS to image ILA 
 
SECONDARY ENDPOINTS:  
1. Correlate ILA grade to metrics reflecting the difficulty of TLE   
2. Fluoroscopy time of the procedure, number and type of extraction sheaths used, and changes in 
tooling type during the procedure. 
 
Primary safety endpoints: 
1. Major complications during lead extraction as defined by the 2017 HRS expert consensus 
statement on cardiovascular implantable electronic lead management and extraction 4]. These 
include death, cardiac avulsion, vascular laceration, and pericardial effusion, requiring 
intervention during the extraction procedure. 
 
 
STUDY DESIGN  
OVERALL STUDY DESIGN:  
This study will be conducted at 4 major institutions (University of Chicago Medicine, Penn Medicine, 
University of Michigan, Allina Health) that specialize in TLE. The investigators in this study are 
electrophysiologists with expertise in TLE and imaging using ICE. All adult patients over the age of 21 
years scheduled to undergo lead TLE for any indication will be eligible to participate as long as the lead 
dwell time is greater than 1 year.  
Duration of study: 1 year 
 
SUBJECT SELECTION AND WITHDRAWAL  
SITES: 
Subjects selected for study will be recruited from 4 sites: University of Chicago Medicine, Chicago, IL; 
Penn Medicine, Philadelphia, PA; University of Michigan, Ann Arbor, MI; Allina Health, St.Paul, MN 
Eligibility: Patients that have been recommended for lead extraction are eligible for enrollment. 

Version: 2021Oct15 
7 
A total of 100 eligible patients will be enrolled in the study. Twenty-five patients will be enrolled at each 
site which will allow 2 things: (1) the operator will first become comfortable with interpreting the images 
obtained from IVUS (5 patients) and (2) imaging from the remaining 20 patients will help reinforce 
understanding of the grading scale [25 patients x 4 sites  = 100 patients]. Assuming a Pearson correlation 
sample size calculation: 
• 
Power:  80% 
• 
Alpha Value:  5% 
• 
Baseline Ho Correlation:  0.50 
• 
Alternative Correlation:  0.70  
• 
Drop-Out Rate: 20% 
• 
Sample Size Calculation:  100 patients 
See Appendix D for further information. 
Inclusion:  
• 
Patients at least 21 years of age 
• 
Patients with at least one lead over 1 year dwell time requiring extraction 
Exclusion: 
• 
Inability of patient capacity to provide consent for themselves either due to medical or 
psychiatric comorbidity 
• 
Venous occlusion to the extent that the IVUS catheter cannot pass 
• 
Leads < 1 year dwell time requiring extraction 
 
STUDY DEVICE 
Visions® PV.035 IVUS catheter (Volcano, San Diego, CA) [Appendix B] 
 
STUDY PROCEDURES 
SCREENING VISIT 
Patients will be screened for the study using inclusion and exclusion criteria outlined in Section 3. 
Informed consent will be obtained as detailed in Section 0. The following data will be collected at 
screening once informed consent is obtained: 
Demographics to Record: 
1. Baseline characteristics: 

Version: 2021Oct15 
8 
a. Age 
b. Gender 
c. Body mass index 
d. Height 
e. Race 
2. Medical Co-morbidities 
a. Diabetes 
b. Creatinine clearance rate (ESRD) 
c. Hypertension 
d. Coronary artery disease 
e. Prior open chest surgery 
f. Left ventricular ejection fraction (%) 
g. NYHA functional class 
3. Lead Data 
a. Reason for extraction (indication per HRS Consensus Guidelines) 
b. Type of leads 
i. Location 
ii. Fixation type 
iii. Function 
iv. SVC Coil (Y/N, single or dual) 
c. Number of leads 
d. Lead dwell times 
4. Routine laboratory data including blood culture or wound culture results if applicable.  
5. Chest x-ray findings 
6. Transesophageal echocardiography (TEE) or transthoracic echocardiogram (if performed)  
 
  
PROCEDURE 
Transvenous lead extraction (TLE) should be performed in an EP lab, cardiac OR or hybrid lab as is 
customary based on the operator’s preference. A PA and lateral CXR is recommended any time prior to 
TLE to confirm the number, type and location of all implanted leads and hardware. The following tests 
are recommended but left to the discretion of the operator: (1) transesophageal echocardiography (TEE) 
or transthoracic echocardiogram to look for vegetations (thrombus w/ infection indication) and tricuspid 
valve (TV) regurgitation, and (2) right or left subclavian vein venogram to evaluate patency of venous 
structures. If performed, reports of these tests will be collected. Prior to the start of the procedure, the 
operator will need to perform the following assessment:  
1. Assessment of risk and /or difficulty of extraction based on clinical variables alone 
a. Based on the following clinical variables, what is your assessment of risk or 
difficulty of extraction? (LOW (L) = 1 point, MODERATE (M) = 2 points, HIGH 
(H) = 3 points) 
i. Lead dwell time 
 
 
LOW  
MODERATE HIGH 
ii. Number of leads in vascular space LOW  
MODERATE  HIGH 

Version: 2021Oct15 
9 
iii. Type of lead  
 
 
LOW  
MODERATE  HIGH 
iv. BMI of patient 
 
 
LOW   
MODERATE HIGH 
v. Patient age  
 
 
LOW  
MODERATE HIGH 
vi. Gender (male=1 point, female=2 points) 
TOTAL: 6-8 points = overall LOW risk , 9-11 = MODERATE risk,  12-17  = HIGH risk  
b. Are you planning on inserting the Philips Rescue Balloon guidewire (PRB-G) during 
this case? 
i. If Yes, why? 
ii. If No, why not? 
iii. If you are going to use the PRB-G, are you planning on inserting the Rescue 
Balloon up front?  YES or NO 
Two or more large (7F – 12F) venous sheaths will be inserted in the right and left femoral veins as per 
standard of care as part of the TLE procedure. A 8.5F SRO or other long sheath can help direct the IVUS 
(Visions® PV.035) catheter and may be used as one of the two standard of care access sheaths. If a long 
sheath is not used, an 8.5 F short sheath is the minimum size required to use the IVUS catheter.  
Prior to pocket access, the IVUS catheter is inserted through a right or left femoral venous approach and 
advanced under fluoroscopic guidance to the RA. If the pacemaker lead entry is in left pectoral region, 
imaging will begin from the innominate vein using the medial end of left clavicle as the origin, registered 
under fluoroscopy. If the pacemaker leads start from right pectoral region, then imaging begins in the 
cranial portion of SVC, using the medial end of the right clavicle as origin, registered under fluoroscopy. 
A 0.32 guidewire can help with IVUS catheter manipulation if necessary.  
Based on fluoroscopy alone, in left sided device implants, the chest will be divided into 3 zones: Zone 
1includes the area between the head of the clavicle and the innominate vein; zone 2 includes the area 
between the innominate vein to SVC-RA junction and zone 3 includes the area between the SVC-RA 
junction through to the mid RA. In right sided device implants, zone 1 includes the area between the head 
of clavicle to the SVC-RA junction; zone 2 includes SVC-RA junction through to the mid RA.  
From there the physician retracts the IVUS catheter through the SVC to the RA in a “survey” run, looking 
for areas of ILA between the lead and the SVC wall in the previously outlined zones. He/she will also 
note the presence of lead-on-lead binding. At least one representative image from each zone will be 
recorded, labelled and saved on the IVUS console. Fluoroscopic images of IVUS catheter position at each 
site of image recording will be saved and labelled.  Using the following scale, grading of ILA in each 
zone of interest, based on relative motion of lead will be performed: 
i. Grade 1: Freely mobile, Rarely adjacent to vasculature 
ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature 
iii. Grade 3: Immobile, Always adjacent to vasculature 
iv. Grade L, added to number: Lead-to-lead binding 
If no ILA is seen, the extraction procedure commences.  

Version: 2021Oct15 
10 
If physician identifies locations of adhesions, he/she returns the IVUS catheter to those locations to 
evaluate severity of adhesion and quantify adhesions based on standardized grading scale which is 
outlined above. Once all adhesions are evaluated, the extraction procedure commences and the physician 
gains pocket access and prepares the lead for extraction. The subjective amount (small, moderate, large) 
of pocket calcification needs to be noted.  
The physician begins the extraction until the leads are free through the subclavicular space. At this point, 
a second run of IVUS imaging is done focusing on areas of highest adhesion seen in the initial imaging. 
These IVUS images will be collected and saved. When adhesion areas are located, traction is applied to 
lead of interest to watch the dynamic response of lead movement, then regraded accordingly. Both grades, 
initial and secondary, should be recorded. The highest grade of adhesion seen in the zone of interest is 
recorded for that lead. Once this is done, the IVUS catheter may or may not be removed during the 
extraction procedure. It may left in the low RA to monitor for pericardial effusion development. Added 
imaging protocol should add 10 minutes to the overall procedure. 
During the extraction, the following information needs to be recorded: Laser pulse number of lasing per 
zone, number of handle pulls for mechanical sheath and time of progression through zone of interest.  
Once the extraction is completed, the following data will be collected:  
Procedural Data to Record: 
1 
Length of Procedure (Patient-on-table to wheel-out) 
2. Order of leads extracted 
3. IVUS Procedure 
a. Length of imaging time 
b. Location of adhesions (images will be captured and collected for the study)  
c. Grading of adhesion in zone of interest, based on relative motion of lead: 
i. Grade 1: Freely mobile, Rarely adjacent to vasculature 
ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature 
iii. Grade 3: Immobile, Always adjacent to vasculature 
iv. Grade L, added to number: Lead-to-lead binding 
4. Length of Extraction (Opening pocket to start of re-implantation, if applicable) 
5. Extraction tools  
a. Laser, Mechanical, Dilating Sheath 
b. Starting sheath size 
c. Change of sheath size, settings (40 v. 80Hz), and type 
d. Use of Outer Sheath 
e. Switching of leads to extract 
6. Location of adhesions felt by extractor 
7. Operator rating about ease of sheath advancement  in each zone (zones 1-3): 
a.  None – removed without sheaths 
b.  0 – advanced without power assistance 
c. 1 – Power assistance but easily advanced 
d. 2 – Power assistance with effort 

Version: 2021Oct15 
11 
8. Laser pulse number of lasing per segment 
9. Number of handle pulls for mechanical sheath 
10. Time of progression through zone of interest  
11. Pocket calcification (Y/N) 
12. Clinical Outcome Data: 
a. Extraction procedural success, as defined above 
b. Major/minor complications, as defined by 2017 HRS consensus guidelines 
c. Complications from IVUS catheters (if any) 
  
PREDISCHARGE 
The patient will be assessed at pre-discharge for the occurrence of any major adverse events including: 
death, need for open heart surgery, cardiac tamponade, or need for re-operation. 
 
STATISTICAL PLAN AND CONSIDERATIONS 
Using Stata statistical software (StataCorp LP, College Station, Texas), ILA grades will be correlated to 
the time required and amount of laser pulsations delivered to traverse each vascular segment. Spearman 
correlation coefficients will be calculated. The student’s T-test will be used for continuous comparisons. 
Fisher’s exact or the Chi-square test will be applied for dichotomous variables. 
 
RISKS AND BENEFITS 
RISKS  
It is standard of care to insert 2 or more large (7F – 12F) venous sheaths in the right and left femoral veins 
during TLE. This is done to provide access for large volume resuscitation and a conduit for temporary 
peripheral bypass in the event of a major vascular complication like SVC or RV tear [4]. In many centers 
ICE is already being utilized during TLE to monitor for complications. This study will require the 
operator to manipulate the IVUS catheter in the RA, SVC and IV. Potential risks of the overall procedure 
include venous perforation leading to cardiac tamponade. Based on published data, the risk of this event 
occurring is very low [11-13]. Specifically, in a recent review of ICE/IVUS in EP procedures that was 
published in 2018, ICE/IVUS use was not associated with   any major complications. Additionally, there 
were no adverse events seen with use of IVUS in our cohort of 56 patients that Drs. Beaser and I studied. 
Please refer to IFU’s for potential risks associated with IVUS catheter. [Appendix B] While we believe 
there are little to no added risks for using IVUS, procedure time may be increased by 10 minutes in order 
to capture images via IVUS. In our experience though, the acquisition of IVUS images can be done 
simultaneously with other parts of the procedure thereby not adding any additional time to the procedure.  

Version: 2021Oct15 
12 
BENEFITS 
IVUS shows promise as a tool to evaluate the presence of ILA in the SVC and other cardiac structures. 
This could potentially allow operators to risk-stratify the allowing them to better select the resources, 
tools and approach to the procedure. 
 
SAFETY AND ADVERSE EVENTS 
Monitoring of Adverse Events 
During the procedure, participants will be monitored by physicians (including anesthesiology), nurses, 
and technicians in accordance with standard operating procedures for routine catheter ablation 
procedures.  Real-time hemodynamic monitoring during the procedure will be measured using arterial 
access.  Real-time cardiac visualization will occur with the use of intracardiac echocardiography. 
Post-operative monitoring will follow standard care for clinical ablation procedures, which includes 
overnight admission for observation with monitored telemetry and measurement of heart rate, blood 
pressure, oxygen saturation, and respiratory rate.  
Table 1 Adverse Event Definitions and Grading 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Any untoward medical occurrence, unintended disease or injury, or 
any untoward clinical signs (including an abnormal laboratory 
finding) in subjects, users or other persons, whether or not related to 
the investigational medical device. 
 
This definition includes events related to the procedures involved (any 
procedure in the clinical investigation plan). 
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event related to the use of an investigational medical device 
 
This definition includes any adverse event resulting from insufficient 
or inadequate instructions for use, the deployment, the implantation, 
the installation, the operation, or any malfunction of the 
investigational medical device. 
 
This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event that led to: 
• 
Death 
• 
Serious deterioration in the health of the subject, that either 
resulted in: 
o a life-threatening illness or injury, or 

Version: 2021Oct15 
13 
Term 
Definition 
o a permanent impairment of a body structure or a body 
function, or 
o in-patient or prolonged hospitalization of existing 
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 
• 
Fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
 
NOTE: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event. 
Serious Adverse Device 
Effect (SADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Unanticipated Adverse 
Device Effect (UADE) 
 
Ref: 21 CFR Part 812 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects.   
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with 
respect to its identity, quality, durability, reliability, safety or 
performance. 
NOTE: Device deficiencies include malfunctions, misuse or use 
errors, and inadequate labeling. 
 
Underlying diseases are not reported as AEs unless there is an increase in severity or frequency during the 
course of the investigation. 
A.  Assessing Relationship to Study Device  
The site investigator will be responsible for assessing the relationship of the AE to the study device as 
related or unrelated, and for reporting the event to UChicago according to criteria in Appendix C. 
Table 2 Adverse Event Relatedness Criteria 

Version: 2021Oct15 
14 
Classification 
Description 
Unrelated 
The adverse event is determined to be due to a concurrent illness or effect 
of another device/drug and is not related to the investigational product. 
Related 
• 
The adverse event is determined to be potentially related to the 
investigational product, and an alternative etiology is equally or less 
likely compared to the potential relationship to investigational 
product, or 
• 
There is a strong relationship to investigational product, or recurs on 
re-challenge, and another etiology is unlikely, or 
• 
There is no other reasonable medical explanation for the event. 
 
B. Adverse Event Reporting 
Adverse events should be reported to the UChicago study team according to the table in Appendix C.  
The site investigator is responsible for expeditiously evaluating adverse events for severity and causality 
designation according to details in Tables 1 and 2.   The site investigator is responsible for providing 
supporting documentation to UChicago. All AEs that are considered related to the study or the device 
must be followed to resolution.   
The UChicago study team will report adverse events to the FDA, UChicago IRB, and Phillips according 
to details in Appendix C.   
All SAEs reported from participating sites will be reviewed by the Lead Principal Investigator or his/her 
physician designee. Only those determined to be serious and unexpected by the Lead Principal 
Investigator will be distributed to participating sites. If Phillips informs the Lead PI of new device 
information that impacts the safety of subjects, the UChicago study team will be responsible for 
distributing this information to sites. 
A safety monitor (a physician who is not part of the study and does not perform TLE) will be designated. 
His/her role will be to evaluate and adjudicate any potential IVUS related adverse events. The study will 
be halted upon the discovery of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study. 
STUDY MONITORING, AUDITING AND INSPECTING 
The University of Chicago responsibility as the clinical sponsor is to ensure protocol and regulatory 
compliance through proper monitoring of the investigation. The University of Chicago requires IRB 
review and a subject Informed Consent Form for all research. Monitoring may be conducted remotely by 
The University of Chicago Research Office. 

Version: 2021Oct15 
15 
Through centralized monitoring, The University of Chicago will assess the site’s performance in the 
following areas: 
- 
Verification that informed consent was obtained and documented properly 
- 
Adherence to protocol eligibility criteria and requirements 
- 
Conduct and documentation of procedures and assessments related to: 
- 
Study endpoints 
- 
Protocol required safety assessments 
- 
Evaluating, documenting, and reporting unanticipated adverse device effects, subject deaths, 
and withdrawals, especially when a withdrawal may be related to an adverse event. 
- 
Investigator oversight and delegation of authority to study personnel 
- 
Verification of study-specific required documentation 
- 
Conduct and documentation of procedures essential to trial integrity 
As the investigator, the physician is responsible for conducting the study in accordance with the signed 
agreement, the investigational plan (protocol), applicable laws, FDA regulations, and any conditions of 
approval imposed by the reviewing IRB/EC. The principal investigator must also accept responsibility for 
all aspects of the study including the actions of any sub-investigators participating in the study at the 
investigational site. 
Data Monitoring 
The responsibility of The University of Chicago as sponsor is to ensure protocol and regulatory 
compliance through proper monitoring of the clinical investigation in U.S. sites. The University of 
Chicago is also required to ensure that the device is used under the immediate direction of an investigator. 
As the investigator, the physician is responsible for conducting the clinical investigation in accordance 
with the signed study agreement, the study protocol, and applicable laws. The primary investigator must 
also accept responsibility for all aspects of the clinical investigation including the actions of any co-
investigators participating in the clinical investigation at the investigational site. 
Study data will be reviewed and source verified at The University of Chicago to ensure that the 
investigator and the clinical investigation team conducts the clinical investigation in accordance with the 
clinical investigation protocol and applicable FDA and local laws and regulations to ensure adequate 
protection of the rights, safety and wellbeing of subjects and the quality and integrity of the resulting data. 
 
PATIENT INFORMED CONSENT 
All study subjects must provide written informed consent using the applicable IRB informed consent 
form.  Each patient will receive a copy of his/her signed consent form.  The original signed consent 
document must be kept on file at the investigative site. 
The study must be explained in a language that is understandable to the patient and s/he must be allowed 
sufficient time to decide whether to participate in this study. All subjects will be assured that they have 

Version: 2021Oct15 
16 
the right to withdraw from the study at any time during the course of the protocol and this decision will 
not influence his/her relationship with the lead investigator, the treating physician and/or the study staff. 
 
DATA HANDLING, AND RECORD KEEPING, AND CONFIDENTIALITY 
University of Chicago will receive coded study data from participating sites for study analysis. 
Data will be collected on paper by study coordinators at the respective participating sites and transcribed 
into an electronic RedCap database which will be maintained on-campus locations at the University of 
Chicago. Data will be managed by the PIs and study coordinators. Access to the data will be limited to 
site PIs and research coordinators only during the study enrollment period. 
All patient specific identifiers will be kept separate from the primary research database. The research 
database will be organized by a unique patient identifier. 
 
DEVICE TRACKING  
The Industry-Sponsor may ship investigational devices only to qualified investigators participating in the 
clinical investigation.  A tracking system will be used to maintain complete and accurate record of 
shipment and disposition of the investigational devices. Records of shipment shall include the name and 
address of the consignee, type and quantity of device, and date of shipment. 
 
Device Tracking By Investigator 
Investigators are responsible for ensuring that investigational devices are made available only to persons 
who are legally authorized to receive them. Under no circumstances may the investigational device be 
used/made available to any person who has not been pre-approved by the Sponsor as an investigator for 
use.    
Each site will record lot and model numbers of each device received onto a device tracking log. When a 
device is used, the subject identification along with the model and lot number of the device used will be 
recorded. Any device returned to the Industry-Sponsor, due to malfunction, expiration, etc. will also be 
documented on the device tracking log. Contaminated devices will be returned to Industry-Sponsor in the 
appropriate biohazard packaging. 
Upon completion or termination of a clinical investigation an investigator is required to return to the 
Industry-Sponsor any remaining supply of devices. 

Version: 2021Oct15 
17 
FINANCIAL CONSIDERATIONS 
No remuneration will be provided to subjects. Funding for this study will be provided by the industry 
sponsor: Philips. The industry sponsor will be providing the Visions® PV.035 IVUS catheter and 
accompanying console to the sites for use in this study.  
 

Version: 2021Oct15 
18 
REFERENCES 
1. Greenspon  AJ, et al. 16-year trends in the infection burden for pacemakers and implantable 
cardioverter-defibrillators in the United States 1993 to 2008.  JACC. 2011; 58:1001 – 1006 
2. Mond HG, et al. The world survey of cardiac pacing and implantable cardioverter defibrillators. 
PACE 2004;27:955-964 
3. Joy PS, Kumar G, et al. Heart Rhythm 2017;14:839-845 
4. 2017 HRS Consensus Statement on CIED Lead Management and Extraction. Heart Rhythm, Vol 
14, No 12, December 2017 
5. Brunner, M.P., et al., Outcomes of patients requiring emergent surgical or endovascular 
intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm, 
2014. 11(3): p. 419-25. 
6. Lewis, R.K., et al., Preprocedural ECG-gated computed tomography for prevention of 
complications during lead extraction. Pacing Clin Electrophysiol, 2014. 37(10): p. 1297-305. 
7. Biefer, H.R., et al., Generator pocket adhesions of cardiac leads: classification and correlation 
with transvenous lead extraction results. Pacing Clin Electrophysiol, 2013. 36(9): p. 1111-6. 
8. Bracke, F., Complications and lead extraction in cardiac pacing and defibrillation. Neth Heart J, 
2008. 16(Suppl 1): p. S28-31 
9. Mazzone, P., et al., Predictors of advanced lead extraction based on a systematic stepwise 
approach: results from a high volume center. Pacing Clin Electrophysiol, 2013. 36(7): p. 837-44. 
10. Maytin, M., L.M. Epstein, and R.M. John, Lead implant duration does not always predict ease of 
extraction: extraction sheath may be required at < 1 year. Pacing Clin Electrophysiol, 2011. 
34(12): p. 1615-20. 
11. Enriquez A., et al. Use of intracardiac echocardiography in interventional cardiology: Working 
with the anatomy rather than fighting it. Circulation. 2018;137:2278–2294.  
12. Bongiorni, M.G., et al., Intracardiac Echocardiography in Patients with Pacing and Defibrillating 
Leads: A Feasibility Study. Echocardiography, 2008. 25(6): p. 632-638. 
13. Sadek, M.M., et al., Utility of intracardiac echocardiography during transvenous lead extraction. 
Heart Rhythm, 2017. 14(12): p. 1779-1785. 
14. Santoshi R, et al. Iliac vein stenosis is an underdiagnosed cause of pelvic venous insufficiency. J 
Vasc Surg: Venous and Lym Dis 2017. 1-10. 
15. Ganguli S., et al., Inferior vena cava filters placed at the bedside via intravenous ultrasound 
guidance versus fluoroscopic guidance. Ann Vasc Surg. 2017 Feb;39:250-255 
16. Kassavin DS, at al. The transition to IVUS-guided IVC filter deployment in the nontrauma 
patient. Vasc Endovascular Surg. 2011 Feb;45(2):142-5. 
17. Jeyabalan G., et al. Endovascular strategies for treatment of embolizing thoracoabdominal aortic 
lesions. Journal of Vascular Surgery (2014) 59:5:1256-1264.  
18. Di Valentino M., et al. Telementoring during endovascular treatment of abdominal aortic 
aneurysms: A prospective study. Journal of Endovascular Therapy (2005) 12:2:200-205. 
19. Kolluri R., et al. A novel duplex finding of superficial epigastric vein flow reversal to diagnose 
iliocaval occlusion. Journal of Vascular Surgery: Venous and Lymphatic Disorders (2017) 
5:3:358-362.  
 

Version: 2021Oct15 
19 
Appendix A 
SCHEDULE OF EVENTS 
 
Screening 
Procedure 
(Day 0) 
Pre-discharge 
Informed consent 
X 
 
 
Medical Records Review 
X 
 
 
Clinical Evaluation 
X 
 
 
Chest  X-ray report 
X 
 
 
Transesophageal echocardiography 
(TEE) or Transthoracic 
echocardiogram  
X a 
 
 
Transvensous Lead Extraction Data 
 
X 
 
Venogram results 
 
X 
 
IVUS images and Fluoroscopy Pictures 
 
X 
 
Adverse Events 
X 
X 
X 
 
a Discretion of operator 
 
 
 

Version: 2021Oct15 
20 
Appendix B 
 
 
 
 
 
Visions® PV .035 
DIGITAL IVUS cATHETER 
 
 
 
CAUTION – Investigational Device Limited by Federal law to investigational use 
 
 
 
English  
 
 
Page 1 

Version: 2019Aug05 
 
Page 21 of 33 
 
 
 
 
 
                       Visions® PV .035   
 
 
 
                
English  
DIGITAL IVUS Catheter
 

Version: 2021Oct15 
22 
CAUTION: 
1. 
U.S. Federal Law restricts this device to sale by or on the order of a physician. 
2. 
Prior to use, read this entire package insert. 
 
INTENDED USE: 
The Visions® PV .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the 
peripheral vasculature by providing a cross-sectional image of such vessels.  
The Visions® PV .035 ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic 
procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image. 
 
DESCRIPTION: 
The Visions PV .035 catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the 
distal end.  The transducer utilizes a 64-element cylindrical array that  radiates acoustic energy into the surrounding tissue 
and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral 
vessels. 
The Visions PV .035 catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is 
designed to track over 0.035”-0.038” (0.89-0.97mm) guide wires. 
The catheter body has markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of 
the catheter, starting 1 cm from the imaging plane, with the 25th RO marker overlapping the distal-most  wide inked 
marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks 
indicating 5 cm intervals. 
A lubricious GlyDx® hydrophilic coating is applied externally to a distal portion of the catheter.  
The Visions PV .035 catheters may only be used with Volcano s5TM Series and CORETM Series of Systems. 
 
CONTRAINDICATIONS: 
• 
Use in cerebral vasculature  
• 
Situations presenting a reasonable probability of tissue or organ damage 
• 
Vessel spasm 
• 
Severe calcification 
• 
Angiographic evidence of thrombus 
• 
Severe vessel tortuosity 
 
 

Version: 2021Oct15 
23 
 
ADVERSE EFFECTS: 
As with all catheterization procedures, complications may be encountered with the use of the Visions PV .035 digital 
IVUS catheter. Possible adverse effects include, but are not limited to, the following:  occlusion; vessel spasm; vessel 
dissection; perforation, rupture or injury; restenosis; hemorrhage or hematoma; drug reactions; allergic reaction to contrast 
medium; hypo/hypertension; infection; arteriovenous fistula; embolism; entry puncture site bleeding; vascular wall injury; 
vessel thrombosis; pseudoaneurysm (at site of catheter insertion); renal failure; aneurysm; vessel trauma requiring surgical 
repair or intervention; death. 
 
WARNINGS: 
• 
Use of the Visions PV .035 catheters should be restricted to specialists who are familiar with, and have been 
trained to perform, the procedures for which this device is intended. 
• 
The product is supplied sterile; if the pouch is opened or damaged compromising the sterile barrier, please discard 
the product. This product cannot be re-sterilized or re-used. 
• 
The Visions PV .035 catheter is designed for single use only. VOLCANO Corporation (“VOLCANO”), makes no 
warranty, representation or condition of any kind, whether expressed or implied (including any warranty of 
merchantability, suitability or fitness for a particular purpose) respecting the re-use of the catheter. 
• 
In addition, VOLCANO assumes no responsibility or liability for incidental or consequential damages which may 
result from such re-use. Re-use including resterilization of unused product may result in, but is not limited, to the 
following: 
• 
Potential critical harm to patient due to Device Separation, Material Deformation or Infection/Sepsis  
• 
Failure to Image or other device malfunctions 
 
• 
The catheter transducer is a delicate electronic assembly. Deliberate misuse by bending, twisting or any other severe 
physical manipulation will void the warranty. 
• 
Do not use the Visions PV .035 device for purposes other than those indicated. 
 
PRECAUTIONS: 
The Visions PV .035 device is a delicate scientific instrument and should be treated as such. Always observe the 
following precautions: 
• 
Protect the catheter tip from impact and excessive force. 
• 
Do not cut, crease, knot, or otherwise damage the catheter. 
• 
Protect the electrical connections from exposure to fluid. 
• 
Do not handle the transducer. 

Version: 2021Oct15 
24 
• 
The outside diameter along the entire length of the guide wire should not exceed the maximum specified. 
• 
During use, ensure that the placement of the catheter does not preclude blood flow through the vessel. 
• 
Clean guide wire and flush catheter thoroughly with sterile heparinized normal saline before and after each 
insertion. 
• 
Keep the exterior of the catheter wiped down with sterile heparinized normal saline during prolonged use. 
• 
When inserting the guide wire both catheter and wire must be straight with no bends or kinks, or damage to inner 
lumen may occur.  
• 
Do not advance the guide wire against significant resistance. If binding occurs between the catheter and the guide 
wire while inside the patient, CAREFULLY REMOVE BOTH the wire and catheter and do not use. If binding occurs 
outside of the patient, remove the catheter and do not use. 
• 
When advancing or re-advancing the catheter over a guide wire and through a stented vessel, in the event that the 
stent is not fully apposed against the vessel wall, the guide wire / and or catheter may become entangled in the stent 
between the junction of the catheter and guide wire or within one or more stent struts. This may result in entrapment of 
catheter/guide wire, catheter tip separation, and/or stent dislocation. Never use force to advance the catheter.               
• 
Use caution when re-advancing a catheter over a guide wire and into a stented vessel, in the event that the catheter 
may come in contact with one or more stent struts.  Subsequent advancement of the IVUS catheter could cause 
entanglement between the catheter and the stent(s) resulting in entrapment of catheter/guide wire, catheter tip separation, 
and/or stent dislocation. 
• 
Use caution when removing the catheter over the guide wire from a stented vessel to minimize patient risk. 
• 
The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a 
tight stenosis. 
• 
If resistance is encountered during pullback, remove the entire system (guide wire, IVUS catheter, sheath/guide 
catheter) at the same time. 
 
INSTRUCTIONS FOR USE: 
The Visions PV .035 catheter may be introduced into the vascular system percutaneously or surgically and advanced to 
the desired location. The frequency and duration of administration is subject to the discretion of the physician and depends 
upon the procedure and information required. 
• 
Review the Volcano Imaging System Operator’s Manual thoroughly prior to use of this device. Check system 
operation prior to the use. 
• 
Open the Visions PV .035 catheter packaging using sterile technique and place the hoop in the sterile field. 
• 
Prepare the catheter by flushing the guide wire lumen through the port at the catheter’s Y-connector, and then wipe 
down the entire working length with sterile heparinized normal saline. 
• 
Remove the clear/white cap from the PIM connector. 
• 
Connect the PIM connector of the Visions PV .035 catheter to the Patient Interface Module as described in the 
imaging system Operator’s Manual. Verify that the device is imaging. 

Version: 2021Oct15 
25 
• 
Place the Visions PV .035 catheter onto the intravascular guide wire. A guide wire of 0.035” (0.89 mm)-0.038" (0.97 
mm) can be used. 
• 
Activate the hydrophilic coating using sterile heparinized normal saline. 
• 
Advance the Visions PV .035 catheter over the guide wire to the site of the vasculature to be imaged. The guide wire 
should always be advanced ahead of the IVUS catheter. 
• 
Check the Monitor for an image. Once the image has been obtained, the catheter can be advanced over the guide wire 
to image additional segments of vasculature. 
• 
If an image is not obtained or is not satisfactory, consult the Volcano Imaging System Operator’s Manual. 
• 
Once imaging has been completed, remove the Visions PV .035 catheter and flush thoroughly with sterile heparinized 
normal saline. 
• 
For subsequent imaging, clean guide wire and flush catheter thoroughly with sterile heparinized normal saline before 
re-insertion. 
• 
When the procedure is completed, remove and discard the catheter in accordance with local regulations. 
 
STORAGE AND HANDLING: 
Products should be stored in a dry, dark, cool place in their original packaging. 
 
PRODUCT SPECIFICATIONS: 
Model Visions PV .035 
Maximum shaft outer diameter 7.0F (0.092", 2.33 mm) 
Maximum scanner diameter 
8.2F (0.108", 2.73 mm) 
Maximum guide wire 
0.038" (0.97 mm) 
Minimum Introducer sheath 
8.5F (0.111”, 2.83 mm) 
Usable length 90 cm 
 
Acoustic Output Parameter  B-Mode  
ISPTA.3 (mW/cm2) 
0.0534 
ISPPA.3 (W/cm2) 
0.0680 
Pr.3 (MPa) 
0.0482 
PD (μs)  
0.333 
PRF (Hz)  
2.09x104 
Center Freq (MHz)  
9.00 
MI* 
0.0162 
TI* 
6.18x10-5 
 
 

Version: 2021Oct15 
26 
Maximum overall uncertainty ±20.4% 
 * As estimated in tissue 
TI:               Thermal Index defined as TI = W01x1fc 
                                                       210 
W01x1:         Bounded-square Output (mW) 
fc:               Center Frequency (MHz) 
MI:              Mechanical Index defined as MI= Pr.3/(fc1/2) 
ISPPA.3:         Derated Intensity, Spatial Peak Pulse Average (W/cm2) 
ISPTA.3:         Derated Intensity, Spatial Peak Temporal Average (mW/cm2) 
Pr.3:           Derated Peak Negative Pressure at a location of the maximum   
                   derated pulse intensity integral (MPa) 
PD:             Pulse Duration (μs) 
PRF:           Pulse Repetition Frequency (Hz) 
 
LIMITED WARRANTY: 
Subject to the conditions and limitations on liability stated herein, Volcano Corporation (“VOLCANO”) warrants that the 
Visions PV .035 catheter (the “Catheter”), as so delivered, shall materially conform to VOLCANO’s then current 
specification for the Catheter upon receipt for a period of one year from the date of delivery. ANY LIABILITY OF 
VOLCANO WITH RESPECT TO THE CATHETER OR THE PERFORMANCE THEREOF UNDER ANY 
WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY WILL BE LIMITED EXCLUSIVELY TO 
CATHETER REPLACEMENT OR, IF REPLACEMENT IS INADEQUATE AS A REMEDY OR, IN VOLCANO’S 
OPINION, IMPRACTICAL, TO REFUND OF THE FEE PAID FOR THE CATHETER. EXCEPT FOR THE 
FOREGOING, THE CATHETER IS PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EXPRESSED OR 
IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF FITNESS, MERCHANTABILITY, AND 
FITNESS FOR A PARTICULAR PURPOSE OF NONINFRINGEMENT. FURTHER, VOLCANO DOES NOT 
WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS REGARDING THE USE, OR THE RESULTS 
OF THE USE, OF THE CATHETER OR WRITTEN MATERIALS IN TERMS OF CORRECTNESS, ACCURACY, 
RELIABILTY, OR OTHERWISE. Licensee understands that VOLCANO is not responsible for and will have no liability 
for any items or any services provided by any persons other than VOLCANO. VOLCANO shall have no liability for 
delays or failures beyond its reasonable control. 
Additionally, this warranty does not apply if: 
1. The Catheter is used in a manner other than described by VOLCANO in the Instructions For Use supplied with 
the Catheter. 

Version: 2021Oct15 
27 
2. The Catheter is used in a manner that is not in conformance with purchase specifications or specifications 
contained in the Instructions For Use. 
3. The Catheter is re-used or re-sterilized. 
4. The Catheter is repaired, altered, or modified by other than VOLCANO authorized personnel or without 
VOLCANO authorization. 
 
If claims under this warranty become necessary, contact VOLCANO for instructions and issuance of a Return Material 
Authorization number if the Catheter is to be returned. Equipment will not be accepted for warranty purposes unless the 
return has been authorized by VOLCANO. 
PATENT www.volcanocorp.com/patents.php 
This product is licensed to the customer for single use only. 
Visions is a registered trademark of Volcano Corporation and is registered in the United States and other countries.  
Volcano and the Volcano logo are registered trademarks of Volcano Corporation in the United States and other countries. 
  
ADDITIONAL QUESTIONS REGARDING THIS PRODUCT SHOULD BE DIRECTED TO: 
 
Legal Manufacturer: 
 
Volcano Corporation 
2870 Kilgore Road 
Rancho Cordova, CA 95670 
USA  
Telephone:       800.228.4728  
                         (916) 638-8008     
Fax:                  916.638.8112 
 
 
 
  
Authorized European Representative: 
 
Volcano Europe BVBA/SPRL 
Excelsiorlaan 41 
B-1930 Zaventem, Belgium 

Version: 2021Oct15 
28 
Telephone:      +32.2.679.1076    
Fax:                 +32.2.679.1079 
 
Manufacturing Sites: 
Volcano Corporation 
2870 Kilgore Road 
Rancho Cordova, CA 95670 USA 
Or 
Volcarica S.R.L. 
Coyol Free Zone and Business Park  
Building B37 
Coyol, Alajuela, Costa Rica 
Telephone: (800) 228-4728 
                    (916) 638-8008   
Fax: (916) 638-8112 
 
 
 
 
 
 
 
 
 
 
 
 

Version: 2021Oct15 
29 
 
 
www.volcanocorp.com 
 
501-0100.12/007 
Revision Date: 10/2015 
 

Version: 15Oct2021 
 
Page 30 of 33 
Appendix C:  Adverse Event Reporting Requirements 
Table 3 Adverse Event Reporting to University of Chicago 
University of Chicago study team contact information: Tiffany Hart, Lead CRA and Hemal Nayak, MD  
Phone #(773)702-0535 and Fax#(773)834-2109 
 
Event Classification 
Event Reporting to University of Chicago (UChicago) 
Adverse Event 
Event recorded and tracked at site. 
Serious Adverse Event  and 
Serious Adverse Device Effects 
Event recorded using study provided reporting forms and reported 
within 48 hours of PI knowledge and required source documentation 
provided 
Unanticipated Adverse Device Effect / 
Unanticipated Serious Adverse Device Effect 
• 
Reported as soon as possible, but within 48 hours of site PI 
knowledge 
• 
Site should call or UChicago CRA (contact above) to report event 
and email thart@medicine.bsd.uchicago.edu  
• 
Event recorded using study provided reporting forms and 
reported within 48 hours of PI knowledge and required source 
documentation provided  
Device Deficiencies (including but not limited to failures, 
malfunctions, and product nonconformities) 
NOTE:  Any Investigational Device Deficiency that might have led to 
a serious adverse event if a) suitable action had not been taken or b) 
intervention had not been made or c) if circumstances had been less 
fortunate is considered a reportable event. 
• 
If the defect lead to a serious event, this should be reported as 
soon as possible, but within 48 hours of site PI’s knowledge.  
Otherwise, report within 48 hours of site PI’s knowledge. 
• 
Event recorded using study provided reporting forms and 
reported within 48 hours of PI knowledge and required source 
documentation provided 
 
 
 

Version: 15Oct2021 
 
Page 31 of 33 
 
Table 4 Adverse Event Reporting by University of Chicago  
Event Classification 
UChicago Communication to 
FDA 
UChicago Communication to 
UChicago IRB 
Reporting to Phillips 
Adverse Event 
NA 
Details provided at time of annual 
review, per IRB policy. 
None, as these are expected events. 
Serious Adverse Event  
Serious Adverse Device Effects 
NA 
Details provided at time of annual 
review, per IRB policy, as these are 
not unanticipated events. 
None, as these are expected events. 
Unanticipated Adverse Device 
Effect   
Unanticipated Serious Adverse 
Device Effect 
Reported as soon as possible, but 
within 48 hours of Lead PI 
knowledge.  These would be 
unexpected and would be reported 
to the FDA regardless of IDE status 
for this study. 
UADE reported within 10 days of PI 
knowledge 
USADE reported directly to IRB 
Chairman upon PI knowledge, 
followed by formal reporting to the 
IRB within 48 hours. 
Study will be halted if event 
presents a significant or 
unreasonable risk to subjects 
enrolled in the study 
Reported as soon as possible, but 
within 48 hours of Lead PI 
knowledge, including a copy of any 
notification provided to the FDA. 
Device Deficiencies (including but 
not limited to failures, 
malfunctions, and product 
nonconformities) 
NOTE:  Any Investigational 
Device Deficiency that might have 
led to a serious adverse event if a) 
suitable action had not been taken 
or b) intervention had not been 
made or c) if circumstances had 
been less fortunate is considered a 
reportable event. 
Investigational Device Deficiencies 
that might have led to a serious 
adverse event if a) suitable action 
had not been taken or b) 
intervention had not been made or 
c) if circumstances had been less 
fortunate is considered a reportable 
event and will be reported to the 
FDA within 48 hours of Lead PI 
knowledge. 
All other device deficiencies will 
be reported within 10 days. 
Investigational Device Deficiency 
that might have led to a serious 
adverse event if a) suitable action 
had not been taken or b) 
intervention had not been made or c) 
if circumstances had been less 
fortunate is considered a reportable 
event will be reported to the IRB 
within 10 days of PI knowledge. 
Investigational Device Deficiencies 
that might have led to a serious 
adverse event if a) suitable action 
had not been taken or b) 
intervention had not been made or c) 
if circumstances had been less 
fortunate is considered a reportable 
event and will be reported within 48 
hours of Lead PI knowledge, 
including a copy of any information 
provided to the FDA. 
All other device deficiencies will be 
reported within 10 days. 

Version: 15Oct2021 
 
Page 32 of 33 
Appendix D 
Pearson's Correlation Tests 
 
Numeric Results when H1: ρ0 ≠ ρ1 
──────────────────────────────────────────────── 
Power 
N 
Alpha 
Beta 
ρ0 
ρ1 
0.80092 
80 
0.05000 
0.19908 
0.50000 
0.70000 
 
References 
Graybill, Franklin. 1961. An Introduction to Linear Statistical Models. McGraw-Hill. New York, New York. 
Guenther, William C. 1977. 'Desk Calculation of Probabilities for the Distribution of the Sample 
Correlation 
   Coefficient', The American Statistician, Volume 31, Number 1, pages 45-48. 
Zar, Jerrold H. 1984. Biostatistical Analysis. Second Edition. Prentice-Hall. Englewood Cliffs, New Jersey. 
 
Report Definitions 
Power is the probability of rejecting a false null hypothesis. It should be close to one. 
N is the size of the sample drawn from the population. To conserve resources, it should be small. 
Alpha is the probability of rejecting a true null hypothesis. It should be small. 
Beta is the probability of accepting a false null hypothesis. It should be small. 
ρ0 is the value of the population correlation under the null hypothesis. 
ρ1 is the value of the population correlation under the alternative hypothesis. 
 
 
Summary Statements 
───────────────────────────────────────────────────────── 
A sample size of 80 achieves 80% power to detect a difference of -0.20000 between the null 
hypothesis correlation of 0.50000 and the alternative hypothesis correlation of 0.70000 using a 
two-sided hypothesis test with a significance level of 0.05000. 
 
 
Dropout-Inflated Sample Size 
──────────────────────────────────────────────────── 
 
 
 
Dropout- 
 
 
 
Inflated 
Expected 
 
 
Enrollment 
Number of 
 
Sample Size 
Sample Size 
Dropouts 
Dropout Rate 
N 
N' 
D 
20% 
80 
100 
20 
 
Definitions 
Dropout Rate (DR) is the percentage of subjects (or items) that are expected to be lost at random during 
the 
   course of the study and for whom no response data will be collected (i.e. will be treated as "missing"). 
N is the evaluable sample size at which power is computed. If N subjects are evaluated out of the N' 
subjects 
   that are enrolled in the study, the design will achieve the stated power. 
N' is the total number of subjects that should be enrolled in the study in order to end up with N evaluable 
   subjects, based on the assumed dropout rate. After solving for N, N' is calculated by inflating N using 
the 
   formula N' = N / (1 - DR), with N' always rounded up. (See Julious, S.A. (2010) pages 52-53, or Chow, 
S.C., 
   Shao, J., and Wang, H. (2008) pages 39-40.) 
D is the expected number of dropouts. D = N' - N. 

Version: 15Oct2021 
 
Page 33 of 33 
 
Procedure Input Settings 
────────────────────────────────────────────────────── 
 
Autosaved Template File 
C:\Users\sbesser\Documents\PASS 16\Procedure Templates\Autosave\Pearson's Correlation Tests - 
Autosaved 2019_5_6-14_45_54.t120 
 
Design Tab 
Solve For: 
Sample Size 
Alternative Hypothesis: 
H1: ρ0 ≠ ρ1 
Power: 
0.80 
Alpha: 
0.05 
ρ0 (Baseline Correlation): 
0.50 
ρ1 (Alternative Correlation): 
0.70