Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency
Sponsor: University of Pennsylvania

 
 
 
 
 
 
 
 
 
Randomized trial comparing VectorFlow tunneled dialysis catheter to Palindrome 
tunneled dialysis catheter 
 
NCT02685995 
 
Protocol date July 6, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
CONFIDENTIAL 
This material is the property of the University of Pennsylvania.  Do not disclose or use except as authorized in writing by the study 
sponsor 
CLINICAL RESEARCH PROTOCOL 
 
 
 
 
Randomized trial comparing VectorFlow tunneled dialysis 
catheter to Palindrome tunneled dialysis catheter 
 
 
 
 
Regulatory Sponsor: 
Gregory Nadolski (PI) 
Funding Sponsor: 
Arrow Medical 
Study Product: 
VectorFlow 
Protocol Number: 
TBD 
IND Number: 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Initial version: 9/01/2015 
Amended: 
9/22/2015 
Amended: 
06/06/2018 

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Table of Contents 
 
STUDY SUMMARY ...................................................................................................................................... 1 
1 
INTRODUCTION .................................................................................................................................... 1 
1.1 
BACKGROUND ................................................................................................................................... 2 
1.2 
INVESTIGATIONAL AGENT ................................................................................................................... 2 
1.3 
PRECLINICAL DATA ............................................................................................................................ 3 
1.4 
CLINICAL DATA TO DATE .................................................................................................................... 3 
2 
STUDY OBJECTIVES ............................................................................................................................ 3 
3 
STUDY DESIGN ..................................................................................................................................... 4 
3.1 
GENERAL DESIGN .............................................................................................................................. 4 
3.2 
PRIMARY STUDY ENDPOINTS .............................................................................................................. 4 
3.3 
SECONDARY STUDY ENDPOINTS ......................................................................................................... 4 
4 
SUBJECT SELECTION AND WITHDRAWAL ...................................................................................... 5 
4.1 
INCLUSION CRITERIA .......................................................................................................................... 5 
4.2 
EXCLUSION CRITERIA ......................................................................................................................... 5 
4.3 
SUBJECT RECRUITMENT AND SCREENING ........................................................................................... 5 
4.4 
EARLY WITHDRAWAL OF SUBJECTS .................................................................................................... 6 
4.4.1 
When and How to Withdraw Subjects...................................................................................... 6 
4.4.2 
Data Collection and Follow-up for Withdrawn Subjects ........................................................... 6 
5 
STUDY DRUG ........................................................................................................................................ 6 
5.1 
DESCRIPTIONS .................................................................................................................................. 6 
5.2 
TREATMENT REGIMEN ........................................................................................................................ 6 
5.3 
METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS ............................................................. 7 
5.4 
PREPARATION AND ADMINISTRATION OF STUDY INTERVENTIONS .......................................................... 8 
5.5 
SUBJECT COMPLIANCE MONITORING .................................................................................................. 8 
5.6 
PRIOR AND CONCOMITANT THERAPY .................................................................................................. 7 
5.7 
BLINDINGOFSTUDYINTERVENTIONS .................................................................................................... 7 
6 
STUDY PROCEDURES ......................................................................................................................... 7 
6.1 
VISIT 1 .............................................................................................................................................. 8 
6.2 
VISIT 2 .............................................................................................................................................. 8 
6.3 
ETC. .................................................................................................................................................. 8 
7 
STATISTICAL PLAN .............................................................................................................................. 8 
7.1 
STUDY OBJECTIVES, SAMPLE SIZE DETERMINATION, AND POWER CALCULATION .................................. 8 
7.2 
STATISTICAL METHODS ...................................................................................................................... 9 
7.3 
SUBJECT POPULATION(S) FOR ANALYSIS AND STUDY DURATION .......................................................... 9 
8 
SAFETY AND ADVERSE EVENTS ....................................................................................................... 9 
8.1 
DEFINITIONS ...................................................................................................................................... 9 
8.2 
RECORDING OF ADVERSE EVENTS .................................................................................................... 11 
8.3 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ..................................... 11 
8.3.1 
Investigator reporting: notifying the study sponsor ................................................................ 12 
8.3.2 
Investigator reporting: notifying the Penn IRB ....................................................................... 12 
8.3.3 
Investigator reporting: Notifying a non-Penn IRB .................................................................. 13 
8.3.4 
Sponsor reporting: Notifying the FDA .................................................................................... 13 
8.3.5 
Sponsor reporting: Notifying participating investigators......................................................... 14 
8.4 
UNBLINDING PROCEDURES ............................................................................................................... 14 
8.5 
STOPPING RULES ............................................................................................................................ 14 

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8.6 
MEDICAL MONITORING ..................................................................................................................... 14 
8.6.1 
Auditing and Inspection .......................................................................................................... 14 
9 
DATA HANDLING AND RECORD KEEPING ..................................................................................... 14 
9.1 
CONFIDENTIALITY ............................................................................................................................ 14 
9.2 
SOURCE DOCUMENTS ...................................................................................................................... 14 
9.3 
CASE REPORT FORMS ..................................................................................................................... 14 
9.4 
RECORDS RETENTION ...................................................................................................................... 15 
10 
STUDY MONITORING, AUDITING, AND INSPECTING ................................................................... 15 
10.1 
STUDY MONITORING PLAN ............................................................................................................. 15 
10.2 
AUDITING AND INSPECTING ............................................................................................................. 15 
11 
ETHICAL CONSIDERATIONS........................................................................................................... 15 
12 
STUDY FINANCES ............................................................................................................................ 15 
12.1 
FUNDING SOURCE ......................................................................................................................... 15 
12.2 
CONFLICT OF INTEREST.................................................................................................................. 15 
12.3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................................. 16 
13 
PUBLICATION PLAN ........................................................................................................................ 16 
14 
REFERENCES ................................................................................................................................... 16 
15 
ATTACHMENTS ................................................................................................................................ 17 
 

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List of Abbreviations 
 
 
 
ESRD – End Stag Renal Disease 
HD – Hemodialysis 
TDC – Tunneled Dialysis Catheter 
AVG – Arteriovenous graft 
AVF – Arteriovenous fistula 
TPA – tissue plasminogen activator 
Kt/V – dialyzer clearance of urea x dialysis time/volume of distribution 
URR – urea reduction ratio 
 
 
 
 
 
 

PCO in Malignant Ascites Treated with PVS 
 
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Study Summary 
Title 
Randomized trial comparing VectorFlow tunneled dialysis catheter 
to Palindrome 
 
Short Title 
VectorFlow vs Palindrome 
Protocol Number 
TBD 
Phase 
N/A 
Methodology 
Randomized two-arm study examining 90 day primary patency of two 
FDA-approved tunneled dialysis catheters 
Study Duration 
15 months 
Study Center(s) 
Penn Medicine University City (Penn Presbyterian Medical Center), 
Pennsylvania Hospital 
Objectives 
Primary:  
90 day primary catheter patency 
 
Secondary: 
90 day primary assisted patency  
Primary, secondary, and total access site service intervals 
Catheter flow and lumen pressure [initial use, qMonth x3 (ie 90 days 
post-catheter insertion)] 
Kt/V, URR, and percent re-circulation [qMonth x3 (ie 90 days post-
catheter insertion)] 
Use of TPA to restore catheter patency 
Cost of maintaining catheter access 
Number of Subjects 
100 
Diagnosis and Main 
Inclusion Criteria 
≥18yo, ESRD requiring insertion of HD catheter 
Exclusions: Known central venous stenosis, infected hemodialysis graft, 
recent bacteremia (< 7 days) 
Design 
Randomized trial with 1:1 allocation 
Duration of 
participation 
90 days from catheter insertion 
Statistical 
Methodology 
Primary patency at 90 days will be analyzed using survival methods with 
the log-rank test and Cox proportional hazards models 
Principal Investigator 
Gregory Nadolski, MD (IR) 
Co-Investigators 
Jonas Redmond, MD (IR) 
Raphael Cohen, MD (Nephrology) 
Key Personel 
Benjamin Hammelman (IR, PAH) 
Raymond Fabrizio (IR, PAH) 
Kathleen Thomas, MS, CRC (Radiology Research Coordinator, UPenn) 
TBD (Biostatistician, UPenn) 
 
 
 
 
1 Introduction 
This document is a protocol for a human research study. This study is to be conducted according to US 
and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference 

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on Harmonization guidelines), applicable government regulations and Institutional research policies and 
procedures.  
1.1 Background 
Tunneled dialysis catheters (TDC) remain an important bridge to permanent hemodialysis access (ie 
arteriovenous graft or fistula) for the majority of patients in the U.S. initiating hemodialysis for end stage 
renal disease (ESRD).  Tunneled dialysis catheters are also a critical transition to new access creation in 
patients with failed arteriovenous access.  Finally, in the subset of dialysis patients who have exhausted 
their venous anatomy for surgical access options and are not candidates for peritoneal dialysis or renal 
transplantation, tunneled dialysis catheters serve as a virtual ‘lifeline’ whose patency determines 
remaining life expectancy(1).  
 
During the high-flow conditions necessary for adequate hemodialysis (HD), fluid dynamics intrinsic to 
specific catheter configurations have implications to catheter thrombosis and dialysis adequacy(2,3). 
Commercially available catheter tip designs have historically comprised step-tip and split-tip 
configurations. In the last decade, symmetrical tip catheters have become widely-utilized alternatives to 
conventional step-tip and split-tip catheters, owing to ease of placement and the ability to reverse lines 
during dialysis without an increase in recirculation(4-6). Regardless of tip design, partial or total occlusion 
of the tip of the catheter is the Achilles’ heel of TDC based HD access. Primary patency rates at 90 days 
can be less then 50%(4,5). Even with the use of thrombolytic drugs to restore patency and flow, mean 
primary assisted patency for TDCs has only been about 135 days in randomized trials (6). 
 
In late 2014, the VectorFlow (Figure 1), a novel symmetrical tip 
catheter was introduced to the U.S. market with the goal of 
achieving improved catheter performance by optimizing fluid 
dynamics through helically-shaped flow-deflecting interfaces at 
the catheter tip intended to reduce platelet activation while 
minimizing recirculation (7,8). To date, no randomized clinical 
trials have been performed comparing efficacy of this design to 
conventional symmetrical tip TDCs. 
 
1.2 Investigational Agent 
 
The VectorFlow is an FDA-approved TDC for patients with 
ESRD requiring HD. The comparison device (Palindrome TDC) 
in this trial likewise is FDA-approved for the same indication. 
Both devices are considered standard of care for catheter based 
HD. Both devices will be placed in accordance with their 
approved indication and manufacture’s instructions for use.  
1.3 Preclinical Data 
During the FDA approval process, the flow characteristics of the novel helical tip design of the VectorFlow 
were examined in comparison to the conventional symmetrical tip design of the Palindrome and other 
catheters using both in vitro and in vivo models(8). In these studies, computational fluid dynamics were 
used to measure shear stress, residence time (RT), platelet lysis index (PLI), and recirculation of the 
study catheters. The VectorFlow catheter was associated with an 18% reduction in mean shear stress 
compared with the Palindrome catheter. In vitro, the VectorFlow catheter had no detectable recirculation 
(0%) compared to 7.3–9.5% with the Palindrome at flow rates of 400–600 ml/minute. In vivo, the 
VectorFlow catheter had no detectable recirculation, compared to 6.7–12% for the Palindrome. 
Subsequently, the absence of detectable recirculation seen with the VectorFlow has been demonstrated 
to be related to the helically contoured lumens which produced the greatest amount of deflection of 
venous flow away from the arterial lumen compared to other catheters (7). Likewise, the VectorFlow was 
shown to have the lowest mean shear-induced platelet activation which could greatly reduce platelet 
Figure 1:VectorFlow catheter tip.   
Helically shaped terminal lumens deflect 
blood flow to minimize recirculation, and to 
produce a transition of blood velocities and 
trajectories as fluid enters and leaves the 
device. 

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aggregation on the catheter tip which can limit flow and result in thrombosis of the catheter or stenosis of 
the veins in which the catheter resides. 
1.4 Clinical Data to Date 
 
Our initial clinical experience using the VectorFlow catheter at the University of Pennsylvania has been 
examined and is currently under review for publication (JVIR submitted May 2015). Over a 5-month 
period, patients initiating hemodialysis with a tunneled dialysis catheter or undergoing exchange of a 
dysfunctional dialysis catheters were retrospectively analyzed.  During this period, a total of 33 
VectorFlow were placed and compared to another commonly used TDC placed at the University of 
Pennsylvania (Ash Split, n=46) TDCs. Patients in the VectorFlow group had significantly greater co-
morbidities and history of thrombosis/occlusion of prior venous access sties. Despite being placed in a 
sicker and more complex patient population, the VectorFlow demonstrated significantly higher primary 
access patency. At 120 days, 89% of VectorFlow catheters remained functional compared to 45% of Ash 
Split catheters (P=0.046). In multivariate analysis, the risk of catheter failure was 13.3 times higher in the 
Ash Split group compared to the VectorFlow (P = 0.004). 
2 Study Objectives 
 
Primary Objectives:  
Assess primary patency at 90 days 
 
Secondary: 
• 
Assess primary assisted patency at 90 days 
• 
Assess need for thrombolytics (ie TPA) to restore catheter patency 
• 
Assess catheter flow and lumen pressures at initial three HD sessions and then monthly for 3 
months (ie up to 90 days following catheter insertion) 
• 
Assess Kt/V (measure of HD adequacy/clearance of urea) and URR monthly for 3 months (ie up 
to 90 days following catheter insertion) 
• 
Assess overall cost to maintain access patency 
3 Study Design 
3.1 General Design 
An open label, randomized trial investigating the 90-day primary patency of the VectorFlow TDC to the 
Palindrome TDC. TDC insertion will be in accordance with its FDA-approved indication for HD access and 
per the manufacturer’s instructions for use. The Palindrome catheter has been selected as the 
comparison device because it is also a symmetrical tip catheter design and prior studies by the 
manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other 
catheter designs (please refer to Palindrome Manufacturer’s Brochure). 
 
Trial Design 
 
Randomization: Patients referred to Interventional Radiology for primary placement of tunneled 
hemodialysis catheter will be screened for enrollment. Following recruitment of those meeting inclusion 
criteria, patients will be randomized 1:1 between insertion of VectorFlow TDC (Arm A) and Palindrome 
TDC (Arm B). Additionally, randomization will also stratify side of catheter placement such that in both 
arms approximately 80% of patients will have right-sided catheters and the remaining 20% left-sided 
catheters. This is to account for the well-established phenomenon of higher rates of catheter failure in left-
side placement due to the curvature and angles induced by the left brachiocephalic vein. 
 
By consenting to participate in this trial, patients will allow the researchers to contact their hemodialysis 
center, including centers outside of the University of Pennsylvania health system, to review parameters 

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from hemodialysis sessions as well as additional clinical information recorded at the HD center regarding 
function of the dialysis catheter.  
 
Post-Insertion Follow-up: Post catheter insertion follow-up will be identical between the two arms of 
treatment. After insertion, patient’s hemodialysis records will be reviewed for (A) Blood flow rate (Qb), (B) 
Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR) These values will be 
recorded from the first 3 hemodialysis sessions and then again at monthly intervals following catheter 
insertion as performed as part of routine clinical care.  
 
Additionally, need and use of prolonged use of thrombolytic infusion (ie t-PA) to restore or improve 
patency and/or need for catheter exchange for any reason will extracted from hemodialysis center 
records as well as the electronic medical record at the University of Pennsylvania. 
 
3.2 Primary Study Endpoints 
 
The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary 
patency is defined as an HD catheter which provides adequate hemodialysis (flow >300mL/min) without 
need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct 
device failure. Device failure is defined as any limitation in catheter function despite technically 
successful catheter placement. Examples of device failure include inadequate rate of blood flow, central 
venous stenosis or thrombosis limiting catheter flow, catheter site infection, or catheter related blood 
stream infection. Primary device service interval is defined as the number of catheter days from TDC 
insertion until removal at the completion of therapy, patient death, conclusion of the study with the 
catheter still functioning, or device failure.  
 
3.3 Secondary Study Endpoints 
1. Primary assisted patency at 90 days defined as an HD catheter which provides adequate 
hemodialysis (flow >300mL/min) without need for catheter exchange or fibrin sheath stripping to 
maintain flow or correct device failure. 
2. Secondary device service interval defined as the service interval that begins after device 
replacement or salvage without abandonment of the access site. Examples of interventions 
include device exchange over a guide wire, fibrin sheath stripping, thrombolytic infusion directly 
into a catheter, catheter tip repositioning, kinked catheter repositioning, and replacement/repair of 
a TDC component. Each device revision results in the start of a new secondary device service 
interval. Patients will be followed up to 12 months post-initial catheter insertion for secondary 
device service interval. 
3. Total access site service interval defined as the sum of all device service intervals at a single 
access site. This accounts for devices replaced or manipulated due to device failure, but 
maintaining the original venous access site. Replacement of an inadvertently removed catheter 
through the existing subcutaneous tunnel results in a new device service interval, but does not 
end the access site service interval. Patients will be followed up to 12 months post-initial catheter 
insertion for total access site service interval. 
4. Catheter flow and lumen pressures at initial three HD sessions and then monthly for 3 
months (ie 90 days) post insertion  
5. URR, and Kt/V, and percent recirculation monthly for 3 months (ie 90 days) post insertion 
Overall cost to maintain access patency during study period 
4 Subject Selection and Withdrawal 
4.1 Inclusion Criteria 
1. End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis 
catheter 

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2. Age >18, Age <80 
3. Capable of giving informed consent 
4.2 Exclusion Criteria 
1. Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh 
frozen plasma 
2. Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion 
3. Active skin infections at site of TDC insertion 
4. Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment 
5. Neutropenia defined as absolute neutrophil count less then 1,700/microliter 
6. Known central venous stenosis 
7. Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of 
the superior vena cava (i.e. venous abnormality precluding catheter placement 
8. Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 
days of enrollment 
9. Inability to provide informed consent 
10. Pregnant or nursing women 
11. In the event a physician does not feel that either catheter would be appropriate for a subject, the 
subject will not be eligible to participate  
4.3 Subject Recruitment and Screening 
 
Currently, approximately 1-3 TDCs are inserted each day by the Interventional Radiology practice at the 
Penn Medicine University City (Penn Presbyterian Medical Center) and Pennsylvania Hospital. These 
patients are referred from the Departments of Medicine and Surgery in consultation with the Division of 
Nephrology.  
 
During the initial contact with the patient, potential candidates will be screened by research coordinator, 
PI, or co-PI for adequacy for the clinical trial. If the applicant meets inclusion criteria without any exclusion 
criteria, the patient will be approached by research coordinator to discuss enrollment. All patients who are 
identified as potential candidates for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their participation in this 
study. The potential subject will be given an opportunity to read the consent form thoroughly and ask and 
be provided answers to any questions that they may have regarding the study. The subject will be asked 
to sign the consent form only if they have indicated that they are willing to do so without reservation. The 
informed consent will be obtained before the subject undergoes any study procedure. The consent form 
must be signed by the subject or legally acceptable surrogate and the investigator or investigator-
designated research professional obtaining consent. The subject will be informed that their participation is 
entirely voluntary and if they chose not participate their care will not be affected and that they may 
withdraw consent at any time. 
4.4 Early Withdrawal of Subjects 
4.4.1 When and How to Withdraw Subjects 
 
• 
PI Decision:  Subjects may be withdrawn at any time during the study if the PI believes it is in the 
subject’s best interest.   In this event, the reasons for withdrawal will be documented. 
• 
Subject Participation:  Refusal to continue treatment, follow-up, comply with the protocol or 
withdrawal of consent. In this event, the reasons for withdrawal will be documented. 
 
Patients withdrawing from the study will be entitled to pursue all treatment options available for the 
treatment of end-stage renal disease and maintenance of hemodialysis access without prejudice from the 
providing physicians. 
 

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Once the subject has discontinued treatment, the primary reason for discontinuing treatment must be 
clearly documented in the subject’s records and on the eCRF.  The investigator will assess each subject 
for response at the time of withdrawal.   
4.4.2 Data Collection and Follow-up for Withdrawn Subjects 
 
Baseline etiology of ESRD will be recorded. Baseline data regarding treatment history of ESRD including 
history of prior hemodialysis access and dialysis access interventions will be collected at time of 
enrollment and will include number and type of prior hemodialysis access and interventions to maintain 
HD access. 
 
Even though subjects may be withdrawn prematurely from the study, it is imperative to collect at least 
primary patency data and suspected date of TDC device failure on such subjects throughout the protocol 
defined follow-up period for that subject.  Such data is important to the integrity of the final study analysis 
of the primary end-point.  If a subject withdraws consent to participate in the study, attempts will be made 
to obtain permission to record at least primary patency data up to the protocol-described end of subject 
follow-up period. Methods that may be used to obtain primary patency data will include phone calls to the 
subject, phone calls to next-of-kin if possible, and certified letters to the subject or next-of-kin. If 
permission to collect or the specific primary patency data cannot be obtained after 4 phone calls and 4 
letters to the subject and/or next-of-kin, the patient will be regarded as lost to follow up. 
5 Study Interventions  
5.1 Descriptions 
 
TDC Insertion  
TDC insertion, either VectorFlow or Palindrome, will be in accordance with its FDA-approved indication 
under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per 
institutional protocol. In brief, using real time ultrasound guidance, access to the internal or external 
jugular vein will be achieved using a 21G needle and a guidewire advanced into the superior vena cava 
under fluoroscopic guidance. A catheter entry site will be selected on the chest wall and anesthetized. 
The catheter will be tunneled subcutaneously to the site of jugular vein access. A peel away sheath will 
be inserted into the jugular vein over a guide wire and the catheter will be inserted. The tip of the catheter 
will be positioned in the mid-right atrium as per the manufacturer’s IFU.  The skin incision overlying the 
venipuncture will be closed with absorbable suture and/or glue. A sterile dressing will be applied to the 
catheter. 
 
Patency and Catheter Performance Measures 
 
Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a 
target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records 
from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate 
(QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, 
need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve 
patency and/or need for catheter exchange for any reason will extracted from hemodialysis center 
records as well as the electronic medical record at the University of Pennsylvania. Subsequently, these 
measures will be recorded monthly up to 90 days following catheter insertion. All times and indication for 
catheter removals and exchanges will be recorded up to 12 months following initial catheter placement. 
5.2 Treatment Regimen 
Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a 
target effective blood flow of 300 mL/min within the first 3 hemodialysis sessions. The dialysis records 
from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate 
(QB),, (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR).  

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Additionally, need and use of thrombolytics (ie tPA) to restore or improve patency and/or need for 
catheter exchange for any reason will extracted from hemodialysis center records as well as the 
electronic medical record at the University of Pennsylvania. Subsequently, these measures will be 
recorded monthly up to 90 days following catheter insertion. All times and indication for catheter removals 
and exchanges will be recorded up to 12 months following initial catheter placement. 
 
  
5.3 Method for Assigning Subjects to Treatment Groups 
The study is a 1:1 randomized open label two arm clinical trial comparing two FDA-approved TDCs. 
Additionally, randomization will take into account likely side of catheter placement such that in both arms 
approximately 80% of patients will have right-sided catheters and the remaining 20% left-sided catheters. 
 
Monthly, the coordinators will provide documentation of the number of patients screened at each site 
(PUMC and PAH) who chose not to enroll in the study. Otherwise, when a screened patient is recruited to 
the study, the coordinator will register the patient into the study database (RedCAP) and generate a study 
identification number which will be recorded on the eCRF. 
5.4 Preparation and Administration of Study Interventions 
 
Both VectorFlow and Palindrome are FDA-approved TDCs and will be inserted using standard clinical 
practice as outlined in manufacturer’s instructions for use. Thus, no special preparation or administration 
of this intervention is necessary. 
 
Women who are able to become pregnant will be tested for pregnancy by urine pregnancy test.  The 
results of this test must be negative to join the study. At the time of enrollment, documentation of 
pregnancy status will be recorded on eCRF as one of the following: (a) reproductive age UPT negative, 
(b) unable to become by nature means and approximate date of menopause, or (c) unable to become 
pregnant by surgical means and date of surgery. 
 
5.5 Subject Compliance Monitoring 
N/A 
5.6 Prior and Concomitant Therapy 
 
Patients may undergo placement of surgical dialysis access during the study period. Patients who 
subsequently use the surgical access for HD and have their TDC removed less than 90 days after 
enrollment can be replaced one for one with additional subjects. 
 
5.7 Blinding of Study Intervention 
This protocol does not utilize blinding. Subjects and investigators will know the treatment being 
administered. 
6 Study Procedures 
6.1 Visit 1: Date of Enrollment and TDC insertion 
Initial consult for TDC insertion. Patient will be evaluated for enrollment in the clinical trial at the time of IR 
consult/procedure visit after consenting to undergo TDC insertion to treat ESRD. After enrollment, the 
patient will be randomized to treatment Arm A (VectorFlow) or treatment Arm B (Palindrome). Following 
randomization, the assigned TDC will be inserted as described above. At time of enrollment, use of anti-

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platelet, anti-coagulants, and/or immunosuppressants will be recorded as these may impact catheter 
patency or infection rates. 
6.2 Visit 2: Initial HD sessions 
Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a 
target effective blood flow of 400mL/min within the first 3 hemodialysis sessions. The dialysis records 
from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate 
(QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D)Urea reduction ratio (URR. Additionally, 
need and use of thrombolytic infusion (ie tPA) (other than single dose administration) to restore or 
improve patency and/or need for catheter exchange for any reason will extracted from hemodialysis 
center records as well as the electronic medical record at the University of Pennsylvania. Subsequently, 
these measures will be recorded monthly up to 90 days following catheter insertion.  
6.3 Visit 2: Follow Up of HD Records 
Subsequently, all measures recorded during the first three HD sessions will be recorded monthly up to 90 
days following catheter insertion. To allow for differences in HD regimens (ie Monday, Wednesday, Friday 
treatment versus Tuesday, Thursday, Saturday treatment regimens), the closest HD session within a 
range of +/- 5 days of the desired follow up date may be used if the exact follow-up date following TDC 
insertion does not fall on a day HD was administered. All times and indication for catheter removals and 
exchanges will be recorded up to 12 months following initial catheter placement. 
 
7 Statistical Plan 
7.1 Study Objectives, Sample Size Determination and Power Calculation 
 
Objectives 
This trial is designed to be the initial randomized trial evaluating the primary patency of the VectorFlow 
TDC compared to a commonly used TDC. The knowledge gained from this investigation will serve as the 
basis for future randomized clinical trials comparing VectorFlow to additional TDC designs. 
 
Primary Objective: To evaluate the primary patency at 90 days of the VectorFlow TDC compared to the 
Palindrome TDC. 
 
Additionally, the trial is designed to assess additional measures of catheter patency as well as catheter 
performance at hemodialysis throughout the study period as detailed in the following secondary 
objectives: 
 
• 
Assess primary assisted patency at 90 days 
• 
Assess need for thrombolytic infusion (ie TPA) to restore catheter patency 
• 
Assess catheter flow and lumen pressures at initial three HD sessions and monthly for 3 months 
(ie up to 90 days following catheter insertion) 
• 
Assess Kt/V (measure of HD adequacy/clearance of urea) and URR monthly for 3 months (ie up 
to 90 days following catheter insertion) 
• 
Assess overall cost to maintain access patency 
 
Sample Size Determination and Power Calculation 
 
Sample size estimation is based on our Primary Objective, the primary patency at 90 days of the 
VectorFlow TDC compared to the Palindrome TDC.  In a prior retrospective analysis, the Palindrome has 
been shown to have a 70% 90-day patency (9); since this patency proportion is associated with only right 
internal jugular placement we expect the Palindrome TDC primary patency to be 60% in this trial 
attributed to the lower patency proportion among left-sided catheter insertions. In our experience at the 
University of Pennsylvania with the VectorFlow catheter, primary patency at 90 days was between 90-

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95% including right and left-sided catheter insertions (see Clinical Data to Date Section 1.4). Using the 
log-rank test for survival proportions (assuming 60% of Palindrome and 90% of VectorFlow catheters will 
remain patent at 90 days), with a two-sided Type I error of 5% and a power of 80%, we will need to enroll 
70 subjects (35 subjects in each arm of the study) (StatMate 2.0, GraphPad Software, San Diego, CA).  
We anticipate 10-15% of subjects in this study will be lost to follow-up during the first 90 days following 
catheter insertion.  Therefore, we will need to enroll 80 subjects (40 in each arm of the study).  If 12 
patients are enrolled per month, then we expect 12-15 months will be needed to complete enrollment and 
follow-up.  
Amendment: Loss of subjects to follow-up or early termination of catheter usage due resuming peritoneal 
dialysis or placement of immediately puncturable AV grafts was higher then the initially anticipated 10-
15%. Thus, to obtain enough analyzable subjects in each arm, we are requesting to increase enrollment 
to 100 subjects (50 in each arm of the study). 
 
 
7.2 Statistical Methods 
 
Primary Objective: Primary patency at 90 days will be analyzed using survival methods with the log-rank 
test and Cox proportional hazards models adjusting for side of catheter insertion (ie left versus right).  
Patients whose catheter remains patent will be censored at the end of study, removal for functioning 
surgical HD access or death. Device failure has been defined above under section 3.2. 
 
Secondary Objectives: Primary assisted patency at 90 days will be analyzed using survival methods with 
the log-rank test and Cox proportional hazards models.  When comparing dichotomous variables in the 2 
treatment groups, a 2-sided χ2 test will be used. Fisher’s exact test will be used for contingency tables 
with fewer than 10 subjects in each category. When comparing continuous variables, a 2-sided t test will 
be used, provided that the distributions are sufficiently close to the normal distribution. Otherwise, a 2-
sided Mann-Whitney test will be used.  
 
7.3 Subject Population(s) for Analysis and Duration of Study 
Analysis of both primary and secondary end points will be performed on an intention to treat basis. 
Approximately 80 patients will be enrolled in this trial. Each patient will be followed for 90 days following 
catheter insertion.  We expect 12-15 months will be needed to complete enrollment and complete follow-
up of all patients. 
 
8 Safety and Adverse Events 
8.1 Definitions 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency  (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc.) 
• Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
 
Adverse Event 

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An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance.   They may jeopardize the subject, and may require intervention to prevent one of the 
other serious outcomes noted above.  For example, drug overdose or abuse, a seizure that did not result 
in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious 
adverse events.  
 
Adverse Event Reporting Period 
The study period during which adverse events must be reported is normally defined as the period from 
the initiation of any study procedures to the end of the study treatment follow-up.  For this study, the study 
treatment follow-up is defined as 30 days following completion of the last survey.  
 
Preexisting Condition 
A preexisting condition is one that is present at the start of the study.  A preexisting condition should be 
recorded as an adverse event if the frequency, intensity, or the character of the condition worsens during 
the study period. 
 
General Physical Examination Findings 
At screening, any clinically significant abnormality should be recorded as a preexisting condition.  At the 
end of the study, any new clinically significant findings/abnormalities that meet the definition of an 
adverse event must also be recorded and documented as an adverse event.  
 
Post-study Adverse Event 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the 
investigator should instruct each subject to report any subsequent event(s) that the subject, or the 
subject’s personal physician, believes might reasonably be related to participation in this study.  The 
investigator should notify the study sponsor of any death or adverse event occurring at any time after a 
subject has discontinued or terminated study participation that may reasonably be related to this study.  
The sponsor should also be notified if the investigator should become aware of the development of 
cancer or of a congenital anomaly in a subsequently conceived offspring of a subject that has participated 
in this study.  
 
Abnormal Laboratory Values 

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A clinical laboratory abnormality should be documented as an adverse event if any one of the following 
conditions is met:  
• The laboratory abnormality is not otherwise refuted by a repeat test to confirm the abnormality 
• The abnormality suggests a disease and/or organ toxicity 
• The abnormality is of a degree that requires active management; e.g. change of dose, 
discontinuation of the drug, more frequent follow-up assessments, further diagnostic investigation, 
etc. 
 
Hospitalization, Prolonged Hospitalization or Surgery 
Any adverse event that results in hospitalization or prolonged hospitalization should be documented and 
reported as a serious adverse event unless specifically instructed otherwise in this protocol.  Any 
condition responsible for surgery should be documented as an adverse event if the condition meets the 
criteria for and adverse event.  
 
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported as an adverse 
event in the following circumstances: 
• Hospitalization or prolonged hospitalization for diagnostic or elective surgical procedures for a 
preexisting condition.  Surgery should not be reported as an outcome of an adverse event if the 
purpose of the surgery was elective or diagnostic and the outcome was uneventful. 
• Hospitalization or prolonged hospitalization required to allow efficacy measurement for the study. 
• Hospitalization or prolonged hospitalization for therapy of the target disease of the study, unless it 
is a worsening or increase in frequency of hospital admissions as judged by the clinical 
investigator. 
8.2 Recording of Adverse Events 
At each contact with the subject, the study team and investigator must seek information on adverse 
events by specific questioning and, as appropriate, by examination.  Information on all adverse events 
should be recorded immediately in the source document, and also in the appropriate adverse event 
module of the case report form (eCRF).  All clearly related signs, symptoms, and abnormal diagnostic 
procedures results should recorded in the source document, though should be grouped under one 
diagnosis. 
 
All adverse events occurring during the study period must be recorded.  The clinical course of each event 
should be followed until resolution, stabilization, or until it has been determined that the study treatment or 
participation is not the cause.  Serious adverse events that are still ongoing at the end of the study period 
must be followed up to determine the final outcome.  Any serious adverse event that occurs after the 
study period and is considered to be possibly related to the study treatment or study participation should 
be recorded and reported immediately. 
8.3 Reporting of Serious Adverse Events and Unanticipated Problems 
 
Investigators and the protocol sponsor must conform to the adverse event reporting timelines, formats 
and requirements of the various entities to which they are responsible, but at a minimum those events 
that must be reported are those that are: 
• related to study participation, 
• unexpected, and  
• serious or involve risks to subjects or others  
(see definitions, section 8.1).   
If the report is supplied as a narrative, the minimum necessary information to be provided at the time of 
the initial report includes: 

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• 
Study identifier 
• 
Study Center 
• 
Subject number 
• 
A description of the event 
• 
Date of onset 
• 
Current status 
• 
Whether study treatment was discontinued 
• 
The reason why the event is classified as serious 
• 
Investigator 
assessment 
of 
the 
association 
between the event and study treatment 
 
8.3.1 Investigator reporting: notifying the medical monitor 
 
N/A 
8.3.2 Investigator reporting: notifying the Penn IRB 
 
This section describes the requirements for safety reporting by investigators who are Penn faculty, 
affiliated with a Penn research site, or otherwise responsible for safety reporting to the Penn IRB. The 
University of Pennsylvania IRB (Penn IRB) requires expedited reporting of those events related to study 
participation that are unforeseen and indicate that participants or others are at increased risk of harm.  
The Penn IRB will not acknowledge safety reports or bulk adverse event submissions that do not meet 
the criteria outlined below.  The Penn IRB requires researchers to submit reports of the following 
problems within 10 working days from the time the investigator becomes aware of the event: 
• Any adverse event (regardless of whether the event is serious or non-serious, on-site or off-site) 
that occurs any time during or after the research study, which in the opinion of the principal 
investigator is: 
Unexpected (An event is “unexpected” when its specificity and severity are not accurately reflected 
in the protocol-related documents, such as the IRB-approved research protocol, any applicable 
investigator brochure, and the current IRB-approved informed consent document and other 
relevant sources of information, such as product labeling and package inserts.) 
AND 
Related to the research procedures (An event is “related to the research procedures” if in the 
opinion of the principal investigator or sponsor, the event was more likely than not to be caused by 
the research procedures.) 
 
Reporting Process 
Unanticipated problems posing risks to subjects or others as noted above will be reported to the Penn 
IRB using the form: “Unanticipated Problems Posing Risks to Subjects or Others Including Reportable 
Adverse Events” or as a written report of the event (including a description of the event with information 
regarding its fulfillment of the above criteria, follow-up/resolution and need for revision to consent form 
and/or other study documentation). 
 
Copies of each report and documentation of IRB notification and receipt will be kept in the Clinical 
Investigator’s study file. 
 
Other Reportable events: 
For clinical drug trials, the following events are also reportable to the Penn IRB: 
• Any adverse experience that, even without detailed analysis, represents a serious unexpected 
adverse event that is rare in the absence of drug exposure (such as agranulocytosis, hepatic 
necrosis, Stevens-Johnson syndrome). 
• Any adverse event that would cause the sponsor to modify the investigators brochure, protocol or 
informed consent form, or would prompt other action by the IRB to assure protection of human 
subjects. 
• Information that indicates a change to the risks or potential benefits of the research, in terms of 
severity or frequency. For example:  

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– An interim analysis indicates that participants have a lower rate of response to treatment than 
initially expected. 
– Safety monitoring indicates that a particular side effect is more severe, or more frequent than 
initially expected. 
– A paper is published from another study that shows that an arm of your research study is of no 
therapeutic value. 
• Change in FDA safety labeling or withdrawal from marketing of a drug, device, or biologic used in 
a research protocol. 
• Breach of confidentiality 
• Change to the protocol taken without prior IRB review to eliminate apparent immediate hazard to a 
research participant. 
• Incarceration of a participant when the research was not previously approved under Subpart C 
and the investigator believes it is in the best interest of the subject to remain on the study. 
• Complaint of a participant when the complaint indicates unexpected risks or the complaint cannot 
be resolved by the research team. 
• Protocol violation (meaning an accidental or unintentional deviation from the IRB approved 
protocol) that in the opinion of the investigator placed one or more participants at increased risk, or 
affects the rights or welfare of subjects. 
8.3.3 Sponsor Reporting: Arrow-Teleflex 
 
Investigators must report serious adverse events (SAE) attributed to TDC insertion to Arrow-Teleflex 
within the timelines described below. The completed case report should be faxed immediately upon 
completion to Arrow-Teleflex. 
 
• 
Relevant follow-up information such as resolution and duration of the SAE attributed to TDC 
insertion should be submitted to Arrow-Teleflex as soon as it becomes available. 
• 
Serious AE reports that are related to TDC and AEs of Special Interest (regardless of causality) 
will be transmitted to Arrow-Teleflex within fifteen (15) calendar days from the date investigators are made 
aware of the AE.  
• 
Serious AE reports that are unrelated to the TDC will be transmitted to Arrow-Teleflex within thirty 
(30) calendar days from the date investigators are made aware of the AE.  
• 
AEs of Special interest are defined as AEs involving central venous occlusion/stenosis occurring 
any time during the study period after TDC has been inserted or catheter related blood stream 
infection occurring less then 7 days after catheter insertion. These events are of special interest 
because they are rare events that can be fatal or result in loss of hemodialysis access. 
• 
All Non-serious Adverse Events originating from the study will be forwarded in a quarterly report 
to Arrow-Teleflex. 
 
8.3.4 Sponsor reporting: Notifying FDA 
 
Medical Device Reporting (MDR): In accordance with FDA regulation (21 CFR 803), the sponsor will 
report to the FDA when they learn that any of their devices may have caused or contributed to a death or 
serious injury. Manufacturers must also report to the FDA when they become aware that their device has 
malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction 
were to recur. 
8.4 Unblinding Procedures 
N/A 

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8.5 Stopping Rules  
The study will be terminated after completed follow up of the last patient enrolled (ie 90 days after this 
patient has TDC inserted). 
8.6 Medical Monitoring 
It is the responsibility of the Principal Investigator to oversee the safety of the study.  This safety 
monitoring will include careful assessment and appropriate reporting of adverse events as noted above, 
as well as the construction and implementation of a site data and safety-monitoring plan (see section 9 
Auditing, Monitoring and Inspecting).   
8.6.1 Auditing and Inspection 
This protocol will be audited and inspected in accordance with DSMP submitted separately. 
9 Data Handling and Record Keeping 
9.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
9.2 Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in 
source documents.  Examples of these original documents, and data records include: hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. 
9.3 Case Report Forms 
The study case report form (eCRF) is the primary data collection instrument for the study. eCRFs will be 
created in the RedCap system to capture the data that the investigator wishes to collect for the purposes 
of research and for safety monitoring. Data will be entered into this system in a timely manner. Forms 
used in the source document should reflect the information needed for the completion of the eCRFs in 
RedCap.  
 
9.4 Records Retention 
 
It is the investigator’s responsibility to retain study essential documents for at least 2 years after the last 
follow up visit with the last enrolled patient.  

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10 Study Monitoring, Auditing, and Inspecting 
10.1 Study Monitoring Plan 
The study PI is responsible for ensuring the ongoing quality and integrity of the research study. In 
addition, this study will be monitored or audited in accordance with Institutional Data and Safety 
Monitoring Plan. The investigator will allocate adequate time for such monitoring activities.  The 
Investigator will also ensure that the monitor or other compliance or quality assurance reviewer is given 
access to all the above noted study-related documents and study related facilities (e.g. pharmacy, 
diagnostic laboratory, etc.), and has adequate space to conduct the monitoring visit. 
10.2 Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, the sponsor, 
government regulatory bodies, and University compliance and quality assurance groups of all study 
related documents (e.g. source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities (e.g. 
pharmacy, diagnostic laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices.  
 
Certain studies, as identified by the ORA, will be monitored on an on-going basis by the DOCM. 
Each study will have an individualized monitoring plan developed by the DSMC and the study team. 
This plan must be approved by the DOCM Director. Once the ORA determines that a study 
needs prospective monitoring, the DSMC will work with the PI and study team to develop a 
monitoring plan that will cover 
 
• All of the Regulatory documentation 
• Informed Consents 
• Eligibility criteria 
• Treatment administration and accountability 
• Adverse/Serious Adverse Events and toxicities 
• Response assessment 
• Subject follow-up 
• Data completeness 
• Source documentation to Case Report Form (CRF) 
• Manufacturing (where applicable) 
 
At the conclusion of the monitoring visit, the monitor will spend time with the PI and/or study team to  
discuss the findings and to provide guidance on resolving deficiencies. A formal letter will be sent to the 
PI within about five business days. The PI does not have to respond the monitoring letter unless 
specifically requested to do so by the monitor. Studies that are high risk protocols are audited 
approximately six months from their first subject accrual and approximately every six month thereafter for 
the duration of the study. However, this schedule may be changed at the discretion of the DSMC. High 
enrolling or quick enrolling studies will be audited more frequently as necessary. Investigators are notified 
in advance of the selection of their protocol for review and cases are randomly selected. Three subjects 
or 10% of the total accrual, whichever is higher, are audited. A formal report is provided to the PI within 
about five business days of the audit. The Committee may alter the frequency of re-monitoring based on 
the audit findings and degree of deficiencies. If an audit is unacceptable due to major deficiencies, 
representatives from the DOCM acting on behalf of the DSMC meet with the PI to discuss the findings of 
the audit and necessary corrective actions. If the deficiencies involve subject safety or serious regulatory 
violations, DSMC Chair, and DOCM Director will meet to discuss necessary actions concerning study 
status. 

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10.3  Study Exceptions and Deviations  
In order to harmonize with the IRB, the DSMC has changed its designations from Deviations and 
Violations to Exceptions and Deviations 
Exception  
A one time, intentional action or process that departs from the IRB and CTSRMC approved study 
protocol, intended for one occurrence. If the action disrupts the study progress, such that the study design 
or outcome (endpoints) may be compromised, or the action compromises the safety and welfare of study 
subjects, advance documented IRB and DSMC approval is required.    
For in-house studies with a Medical Monitor or Safety Monitoring Committee (not DSMB), approval must 
be obtained from the Medical Monitor or Safety Monitoring Committee prior to submitting your exception 
request to the DSMC.  
Deviation 
A one time, unintentional action or process that departs from the IRB and DSMC approved study protocol, 
involving one incident and identified retrospectively, after the event occurred. If the impact on the protocol 
disrupts the study design, may affect the outcome (endpoints) or compromises the safety and welfare of 
the subjects, the deviation must be reported to the DSMC within 5 business days and the IRB within 10 
business days.  
11 Ethical Considerations 
This study is to be conducted accordance with applicable US government regulations and international 
standards of Good Clinical Practice, and applicable institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent Ethics 
Committee (EC) or Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal 
approval of the study conduct.  The decision of the EC/IRB concerning the conduct of the study will be 
made in writing to the investigator and a copy of this decision will be provided to the sponsor before 
commencement of this study.  The investigator should provide a list of EC/IRB members and their affiliate 
to the sponsor. 
 
All subjects for this study will be provided a consent form describing this study and providing sufficient 
information for subjects to make an informed decision about their participation in this study.  See 
Attachment B for a copy of the Subject Informed Consent Form.  This consent form will be submitted with 
the protocol for review and approval by the EC/IRB for the study.  The formal consent of a subject, using 
the EC/IRB-approved consent form, must be obtained before that subject undergoes any study 
procedure.  The consent form must be signed by the subject or legally acceptable surrogate, and the 
investigator-designated research professional obtaining the consent.  
12 Study Finances 
12.1 Funding Source 
Arrow-Teleflex 

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12.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by a properly 
constituted Conflict of Interest Committee with a Committee-sanctioned conflict management plan that 
has been reviewed and approved by the study sponsor prior to participation in this study.  All University of 
Pennsylvania investigators will follow the applicable University conflict of interest policies. 
12.3 Subject Stipends or Payments 
None 
13 Publication Plan 
 
The Principal Investigator and Institution shall be free to publish and present the results and data from the 
Study, subject to Company having the opportunity to review and provide comments to such publication 
pursuant to the terms of the Clinical Trial Agreement. Any such publication or presentation shall 
acknowledge, as appropriate, the contribution of Company, its employees, agents and representatives. 
        Company may utilize all data and results for regulatory compliance filings only, subject to the use 
limitations set forth in the Clinical Trial Agreement concerning protection of Confidential Information and 
process for Publication.. 
14 References 
 
1. 
Vascular Access Work Group. Clinical practice guidelines for vascular access. American journal of 
kidney diseases : the official journal of the National Kidney Foundation. 2006. pp. S248–73.  
2. 
Mareels G, De Wachter DS, Verdonck PR. Computational fluid dynamics-analysis of the Niagara 
hemodialysis catheter in a right heart model. Artificial Organs. 2004 Jul;28(7):639–48.  
3. 
Mareels G, Kaminsky R, Eloot S, Verdonck PR. Particle image velocimetry-validated, computational 
fluid dynamics-based design to reduce shear stress and residence time in central venous 
hemodialysis catheters. ASAIO J. 2007 Jul;53(4):438–46.  
4. 
Kakkos SK, Haddad GK, Haddad RK, Scully MM. Effectiveness of a new tunneled catheter in 
preventing catheter malfunction: a comparative study. JVIR. 2008 Jul;19(7):1018–26.  
5. 
Hwang HS, Kang SH, Choi SR, Sun IO, Park HS, Kim Y. Comparison of the palindrome vs. step-tip 
tunneled hemodialysis catheter: a prospective randomized trial. Semin Dial. 2012 Sep;25(5):587–
91.  
6. 
Van Der Meersch H, De Bacquer D, Vandecasteele SJ, Van den Bergh B, Vermeiren P, De Letter J, 
et al. Hemodialysis catheter design and catheter performance: a randomized controlled trial. Am J 
Kidney Dis. 2014 Dec;64(6):902–8.  
7. 
Clark TWI, Isu G, Gallo D, Verdonck P, Morbiducci U. Comparison of symmetric hemodialysis 
catheters using computational fluid dynamics. J Vasc Interv Radiol. 2015 Feb;26(2):252–2.  
8. 
Clark TWI, Van Canneyt K, Verdonck P. Computational flow dynamics and preclinical assessment 
of a novel hemodialysis catheter. Semin Dial. 2012 Sep;25(5):574–81.  
9. 
Balamuthusamy S. Self-centering, split-tip catheter has better patency than symmetric-tip tunneled 
hemodialysis catheter: single-center retrospective analysis. Semin Dial. 2014 Sep;27(5):522–8.  

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15 Attachments 
 
eCRF 
Monitoring Plan  
ICF 
 
 
 

 
 
 
 
 
 
 
 
 
Randomized trial comparing VectorFlow tunneled dialysis catheter to Palindrome 
tunneled dialysis catheter 
 
NCT02685995  
 
Informed Consent date August 10, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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University of Pennsylvania Research Subject Informed Consent and Health 
Insurance Portability and Accountability Act (HIPAA) Authorization Form 
Protocol Title: 
Randomized trial comparing VectorFlow tunneled dialysis 
catheter to Palindrome tunneled dialysis catheter 
Investigators: 
Gregory Nadolski, MD 
Department of Radiology, Vascular and Interventional Radiology 
Hospital of the University of Pennsylvania 
1 Silverstein, 3400 Spruce Street, Philadelphia, PA 19104 
Daytime Phone Number: 267.251.9926 
Jonas Redmond, MD 
Department of Radiology, Vascular and Interventional Radiology 
Penn University Medical Center 
4 Wright Saunders, 51N. 39th Street, Philadelphia, PA 19104 
Daytime Phone Number: 215.662.9122 
Sponsor: 
Teleflex Medical Incorporated 
4350 Lockhill Selma Road 
Shavano Park, Texas 78249 USA 
24-Hour
Emergency
Contact
Interventional Radiology Fellow On Call  
215.662.2222 (ask to be connected to Interventional Radiology Fellow 
on Call) 
Why am I being asked to volunteer? 
You are being invited to participate in a research study, because you have been 
diagnosed with kidney disease requiring hemodialysis through a tunneled dialysis 
catheter.   
Hemodialysis is a process that replaces the function of the kidneys  by filtering 
toxins and waste materials from the blood.  During hemodialysis, blood must be 
removed, filtered by a machine called a dialyzer, and then returned to the body. 
A tunneled dialysis catheter is one method of providing access to the blood 
stream for hemodialysis. The tunneled dialysis catheter is a piece of synthetic 
tubing that is inserted under the skin of the chest and into a vein in the neck. This 
procedure is frequently performed by Interventional Radiologists.  
Your participation is voluntary which means you can choose whether or not you 
want to be part of the study. If you choose to participate, you will be randomly 
assigned (like flipping a coin) to receive one of two FDA approved tunneled 
dialysis catheters. You have an equal chance of receiving either catheter. 
IRB APPROVAL FROM: 08/10/2018 TO: 08/09/2019

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Before you can make your decision, you will need to know what the study is 
about, the possible risks and benefits of participating in the study, and what you 
will be asked to do if you choose to participate.  The research team is going to 
talk to you about the study, and they will give you this consent form to read. You 
may also decide to discuss it with your family, friends, other doctors, or whoever 
helps you make medical decisions. You may find some of the medical language 
difficult to understand. Please ask the research team and/or the study doctor any 
questions you have regarding this form or the research study. If you decide to 
participate, you will be asked to sign this consent form.  
What is the purpose of this research study? 
Tunneled dialysis catheters are constructed with different designs meant to 
improve blood flow to make dialysis more efficient and minimize occlusion, or 
blockage, of the catheter. Occlusion requires the catheter to be changed and can 
increase chances that the blood vessel it sits in will become narrow or that an 
infection of the blood stream will occur. For these reasons, catheters which 
occlude less often are more desirable.  
The purpose of this study is to examine which of two FDA approved tunneled 
dialysis catheters has the lowest rate of occlusion 90 days after insertion.  
Prior laboratory experiments comparing the two catheters being studied suggest 
one catheter may have better performance during hemodialysis and have lower 
risk of becoming occluded. The present study would provide more conclusive 
evidence of these preliminary findings. 
How many people will be in this research study? 
A total of 100 patients will be recruited between two sites (Penn Medicine 
University City and Pennsylvania Hospital). 
What am I being asked to do? 
You are being asked to allow the study team to contact you and your 
hemodialysis center after insertion of the catheter to obtain information about the 
function of the catheter after the first three dialysis sessions and then monthly for 
about 3 months. After this point, you are being asked to allow the study team to 
contact the dialysis center and review your medical records to determine when 
and why the initial catheter was replaced or removed for a period of up to12 
months following the insertion of the initial catheter. 
No additional tests, therapies or interventions beyond those performed for routine 
clinical care will be performed if you participate. 
Information regarding medications and other health conditions also will be 
obtained from your medical records during these reviews.   
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Women who are able to become pregnant will be tested for pregnancy by urine 
pregnancy test.  The results of this test must be negative to join the study. 
 
What are the possible risks? 
The direct risks of participating in the study are minimal. Both catheters in the 
study and their insertion have the same risks as all currently used dialysis 
catheters including infection, minor bleeding, occlusion of the catheter, and 
narrowing of the blood vessel in which the catheter is inserted. One of the two 
catheters is more commonly placed at the University of Pennsylvania. The 
insertion method and complications of the two catheters are identical. However, 
participation may mean you receive the catheter that is less commonly placed. 
Your participation in this study would permit the investigators to collect personal 
health information and data about you. Personal health information and data from 
your dialysis center regarding function of the catheter will be recorded in a 
password protected electronic database, which is only accessible by members of 
the study team. This information may be shared between study members at all 
participating sites. The results of the data will be reported in aggregate and 
anonymously. This means your information will not be reported by itself or with 
any personal identifiers, such as name or date of birth. However, risk of loss of 
confidentiality is still possible. Finally, as with all investigations, the research may 
involve risks that are currently unforeseeable.  
What are the possible benefits? 
There may be no direct benefit to you. Future patients may benefit from the 
better understanding of the rate of occlusion of the two types of dialysis catheter.  
What other choices do I have if I do not participate?  
You do not have to participate in this study. If you choose not to participate in this 
study, you could choose to receive a currently approved catheter as part of 
routine clinical care, to participate in another research study, or to receive no 
care at all.  
Will I have to pay for anything if I participate? 
You will incur no additional charges for participating in the study.  
Will I be paid for being in this study? 
No, there will be no financial compensation for participation in this study. 
What happens if I am injured from being in this study? 
We will offer you the care needed to treat injuries directly resulting from taking 
part in this research. We may bill your insurance company or other third parties, if 
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appropriate, for the costs of the care you get for the injury, but you may also be 
responsible for some of them. 
There are no plans for the University of Pennsylvania to pay you or give you 
other compensation for the injury. You do not give up your legal rights by signing 
this form.   
If you think you have been injured as a result of taking part in this research study, 
tell the person in charge of the research study as soon as possible. The 
researcher’s name and phone number are listed in this consent form. 
How long will I be in this research study if I participate? Can I leave the 
study before it ends? 
Patients who participate in this study will be followed for 3 months (90 days) after 
the initial insertion of the dialysis catheter. Additionally, your clinical records may 
be reviewed to determine when and why the initial catheter was replaced or 
removed for up to 12 months following catheter insertion. Your participation in 
this study is completely voluntary and you may withdraw at any time without 
affecting your present or future care. You may be withdrawn from the study if 
your physician finds it necessary or in your best interest. 
What information about me may be collected, used, or shared with others? 
Your name, age, medical record numbers, telephone number and dates and 
results from examinations, tests, procedures, and imaging related to the 
treatment of kidney failure and management of your dialysis catheter. 
Why is my information being collected? 
Your information will be used by the investigators to perform the research, to 
oversee the research, and to contact you if necessary. Your personal information 
will not be used in reporting the outcomes of this study. This information is 
collected to ensure the data from the investigation is recorded correctly. This 
information may be shared between study team members at different sites. 
Who may use and share information about me? 
The investigators for the study and the study team may use or share your 
information for this research study. Your information will be shared with the 
sponsor of study, Teleflex Medical Incorporated, a division of Arrow International. 
Additionally, information may be shared with regulatory oversight organizations 
such as the Institutional Review Board at the University of Pennsylvania and the 
FDA. All information shared between study team members will be through a 
password protected electronic database system to protect privacy and 
confidentiality. However, there is still potential risk to confidentiality and privacy. 
How long may the investigators use or disclose my personal health 
information? 
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Your authorization for use of your personal health information for this specific 
study does not expire. Your information may be held in a research database. 
However, the School of Medicine may not re-use or re-disclose information 
collected in this study for a purpose other than this study, unless you have given 
written authorization, the University of Pennsylvania’s Institutional Review Board 
grants permission, or as permitted by law. 
 
Can I change my mind about giving permission for use of my information? 
Yes. You may withdraw or take away your permission to use and disclose your 
health information at any time. You do this by sending written notice to the 
investigator for the study. If you withdraw your permission, you will not be able to 
stay in this study. 
What if I decide not to give permission to use and give out my health 
information? 
Then you will not be able to participate in this research study. 
Who can see or use my information? How will my personal information be 
protected? 
Every attempt will be made by the investigators to keep all information collected 
in the study strictly confidential, except as may be required by a court order or by 
law. If necessary, authorized representatives at the University of Pennsylvania’s 
Institutional Review Board (IRB), a committee charged with protecting the rights 
and welfare of research subjects, or the FDA (Food and Drug Administration) 
may be provided access to our research records. If any publication or 
presentation results from this research, study participants’ data will be reported 
only in aggregate form without any individually identifiable information. 
Additionally, a description of this clinical trial will be available on 
http://www.clinicaltrials.gov, as required by U.S. Law. This web site will not 
include information that can identify you. At most, the web site will include a 
summary of the results. You can search this web site at any time. 
What if new information becomes available about this study? 
You will be provided with a copy of this document for your records. If new 
information about this study is discovered, you will be informed. 
Electronic Medical Records and Research Results 
What is an Electronic Medical Record? 
An Electronic Medical Record (EMR) is an electronic version of the record of your 
care within a health system. An EMR is simply a computerized version of a paper 
medical record. If you are receiving care or have received care within the 
University of Pennsylvania Health System (UPHS) (outpatient or inpatient), and 
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are participating in a research study, results of research-related procedures (i.e. 
laboratory tests, imaging studies and clinical procedures) may be placed in your 
existing EMR maintained by UPHS. 
If you have never received care within either of these systems and are 
participating in a research study that uses services at University of Pennsylvania, 
an EMR will be created for you for the purpose of maintaining any results of 
procedures performed as part of this research study.  The creation of this EMR is 
required for your participation in this study. In order to create your EMR, the 
study team will need to obtain basic information about you that would be similar 
to the information you would provide the first time you visit a hospital or medical 
facility (i.e. your name, the name of your primary doctor, the type of insurance 
you have). Results of research procedures performed as part of your 
participation in the study (i.e. laboratory tests, imaging studies and clinical 
procedures) may be placed in this EMR.  
Once placed in your EMR, these results are accessible to appropriate University 
of Pennsylvania workforce members that are not part of the research team.  
Information within your EMR may also be shared with others who are determined 
by University of Pennsylvania to be appropriate to have access to your EMR (e.g. 
health insurance company, disability provider, etc). 
Who can I call with questions, complaints, or if I’m concerned about my 
rights as a research subject? 
If you have questions, concerns or complaints regarding your participation in this 
research study or if you have any questions about your rights as a research 
subject, you should speak with the Principal Investigator listed on page one of 
this form.  If a member of the research team cannot be reached or you want to 
talk to someone other than those working on the study, you may contact the 
Office of Regulatory Affairs with any question, concerns or complaints at the 
University of Pennsylvania by calling (215) 898-2614. 
 
Disclosure of Money received outside of the study: 
 
This research study is supported by money from Teleflex Medical. In addition, the 
person leading this research study receives compensation from Teleflex Medical 
for work that is not a part of this study and unrelated to hemodialysis, renal 
disease, and dialysis catheters. These activities may include consulting, advisory 
boards, giving speeches or writing reports. If you would like more information, 
please ask the researchers or the study coordinator.  
 
Conclusion: 
When you sign this form, you are agreeing to take part in this research study. 
This means that you have read the consent form, you have been given the 
opportunity to ask questions, your questions have been answered to your 
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satisfaction, and you have decided to volunteer. Your signature also means that 
you are permitting the University of Pennsylvania to use your personal health 
information collected about you for research purposes within our institution. You 
are also allowing the University of Pennsylvania to disclose that personal health 
information to outside organizations or people involved with the operations of this 
study. Upon signing below, you will receive a copy of this consent form.  
 
 
________________________       _____________________________________ 
Name of Subject (Please Print)  
 Signature of Subject   
                         Date 
 
 
________________________ 
_____________________________________ 
Name of Person Obtaining 
 
Signature of Person Obtaining Consent          Date 
Consent (Please Print) 
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