RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)
Phase: NA
Conditions: Angiogram, Percutaneous Coronary Intervention
Sponsor: Wake Forest University Health Sciences

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COVER PAGE 
 
STUDY TITLE: RAVE: Radial Artery Vascular complication and 
rEsource utilization in subjects undergoing an angiogram/PCI 
(Percutaneous Coronary Intervention) 
NCT NUMBER: NCT03522077 
VERSION DATE: 02/11/2021

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AURORA HEALTH CARE, INC. 
 
PROTOCOL TITLE: 
RAVE: Radial Artery Vascular complication and 
rEsource utilization in subjects undergoing an 
angiogram/PCI (Percutaneous Coronary 
Intervention) 
 
 
 
 
 
 
PRINCIPAL INVESTIGATOR:  
Muhammad Fuad Jan, MD 
 
 
 
 
 
 
Physician – Cardiovascular Medicine 
 
 
 
 
 
 
2801 W Kinnickinnic River Parkway 
 
 
 
 
 
 
Suite 474 
 
 
 
 
 
 
Milwaukee, WI 53215 
 
 
 
 
 
 
414.649.3530 
 
 
 
 
 
 
414.385.4436 
 
 
 
 
 
 
 
Fuad.Jan@aah.org 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This protocol was designed and developed by Aurora Healthcare, Inc.  It is 
intended to be used only in conjunction with institution-specific IRB approval for 
study entry. 

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I. Background and Rationale 
Transradial catheterization has been steadily increasing over the years due to reports of lower 
incidence of bleeding and vascular complications,1 decreased cost,2 and improvements in 
patient satisfaction 2,3 when compared to the transfemoral approach. While the complications 
associated with the transfemoral approach are reduced by using transradial catheterization, 
there are unique challenges associated with the use of the transradial approach that require 
development of evidenced-based practices to allow the cath lab and post procedure staff to 
manage and prevent these issues.  
 
The most predominate issue associated with transradial catheterization is radial artery 
occlusion, although it is often asymptomatic due to dual collateral perfusion to the hand.4 
Radial artery occlusion occurs when thrombus forms in the artery that blocks antegrade blood 
flow, thus precluding future use of the radial artery for procedures. Risk of radial artery 
occlusion has been associated with use of anticoagulation (i.e., heparin) during the procedure,5 
repeat entry,6 low radial artery to sheath diameter ratio,7 and prolonged high-pressure 
compression to achieve hemostasis.8 
 
‘Patent’ hemostasis, which is the adjustment of pressure using a hemostasis band to stop 
bleeding without obstructing radial artery flow, has been shown to reduce the occurrence of 
radial artery occlusion by 75% at 30-days post procedure versus use of hemostasis bands 
without evaluation of radial artery flow in a randomized clinical trial.9 Unfortunately, the use 
of high amounts of anticoagulation during the procedure may render this method ineffective at 
preventing bleeding at the insertion site. Additionally, the use of these devices requires 
restriction of wrist movement which may be uncomfortable for the patients. Finally, this 
approach requires significant monitoring on the part of the cath lab personnel in order for it to 
be effective. 
 
Hemostatic patches have been suggested as an alternative approach to reduce the time 
associated with reaching hemostasis, thereby reducing the prolonged application of 
compression. Current hemostatic patches are coated with a marine toxin, thrombin, or 
biopolymer to promote rapid hemostasis at the access site.10 Results of clinical trials using 
chitosan-based hemostatic pads have shown these products to be effective at reducing time to 
hemostasis with minimal complications when used following transradial catheterization.11-12 In 
a study that randomized 75 participants to either a hemostatic band using the recommended 
instructions, hemostatic band using a fast-track approach, and chitosan-based pad, Fech et al. 
(2012) observed a significant reduction in time to hemostasis when a chitosan-based pad was 
applied versus use of the hemostatic band per manufacturer instructions without an increase in 
vascular complications.11 There was no significant differences observed between using the 
chitosan-based pad and a fast-track approach developed for use of the hemostatic band. In a 
larger study of subjects (N=600) randomized to either a hemostatic band or chitosan-based pad, 
the investigators reported that use of the chitosan-based pad significantly reduced the incidence 
of radial artery occlusion at the time of discharge as well as at 30-day follow-up. Additionally, 
they observed a significant decline in time of compression, although this was not a primary 
endpoint of the study design.12 No studies have been conducted that have looked at patient 

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satisfaction or cath lab staff involvement related to the use of hemostatic pads in this patient 
population. 
 
The SoftSeal®-STF hemostatic pad (Chitogen, Inc.) is an FDA-approved, chitosan-based, non-
woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids 
forms a gel-like synthetic clot. It’s mechanism of action is believed to be due to bioadhesion 
between the chitosan polymer chains, which are positively charged, and the negatively charged 
blood and tissue components.13 Several studies have supported the safety of using chitosan-
based products for achieving hemostasis and wound healing.14-16  Additionally, results of a 
small pilot study (N=30) to determine efficacy of the SoftSeal®-STF hemostatic pad to control 
bleeding in patients who underwent transradial catheterization showed that average hold time 
was 13.3 minutes (12-22 minutes) to achieve hemostasis and no complications due to excess 
bleeding or hematoma were observed.17    
 
In summary, radial artery occlusion is a complication associated with transradial 
catheterization that can be prevented by reducing time of compression required to reach 
hemostasis. Mechanical compression devices that apply pressure at the insertion site do not 
lead to radial artery occlusion when used to achieve ‘patent’ hemostasis, but may not be 
effective for preventing bleeding when high levels of anticoagulation are used. Additionally, 
use of these devices may result in discomfort to the patients due to restrictions of wrist 
movement. Currently marketed chitosan-based hemostatic pads have been shown to be at least 
as efficacious in achieving hemostasis following transradial catheterization as the use of a 
hemostatic band, but questions still remain as to whether improvements in time of compression 
and vascular complications can be reliably realized. Additionally, no studies have compared 
patient satisfaction and quality of life between the different types of devices used.  
 
The results of this study will be used to develop evidenced-based practices and guidelines to 
reduce complications unique to transradial catheterizations. The researchers anticipate that use 
of the SoftSeal®-STF hemostatic pad with a vascular compression device will result in 
improved time to hemostasis as well as reductions in vascular complications. These results may 
lead to increased overall satisfaction among patients as well as cath lab staff responsible for 
managing these patients. Finally, use of the SoftSeal®-STF hemostatic pad may benefit the 
healthcare community by further reducing the time to discharge and cost associated with 
providing care to patients undergoing transradial catheterization. 
 
II. 
Study Objectives 
III. The primary objective of this study is to determine if there is a reduction in time to 
hemostasis in subjects treated with SoftSeal®-STF hemostatic pad when used in conjunction 
with a vascular compression device after radial transcatheter procedure. 
 
Secondary objectives of this study include: 
• Assessment of procedure-related measures of patient satisfaction following use of the 
SoftSeal®-STF hemostatic pad with vascular compression devices.   

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• Assessment of vascular complications due to bleeding associated with transradial 
catheterization.  
We hypothesize that: 
• The use of SoftSeal®-STF hemostatic pad when used with vascular compression devices 
will be associated with a significant reduction in time to hemostasis and a decrease in 
vascular complications of radial artery occlusion. 
• Decrease in time to hemostasis will allow for an earlier patient discharge and increase in 
staff productivity. This in combination with the low incidence of vascular complications 
will lead to overall patient satisfaction.  
 
IV. 
Study Design 
This is an open-label, prospective clinical study to evaluate the SoftSeal®-STF hemostatic pad 
when used with a vascular compression device. The first 100 patients enrolled into the study 
will receive the SoftSeal®-STF hemostatic pad and the RadAR EasyCLik. After successful 
completion of the first 100 then the next 100 patients enrolled will receive the SoftSeal®-STF 
hemostatic pad and the TR BAND® Radial Compression Device.   
 
Data from the SoftSeal®-STF hemostatic pad with compression devices (RadAR EasyCLik 
and TR BAND®) will be compared to data previously collected for study purposes to the 
SoftSeal®-STF hemostatic pad alone using manual compression and those who received 
VascBand™ Hemostat. 
 
V. 
Selection and Withdrawal of Subjects 
Subjects will be recruited from Aurora Health Care sites 
 
Subjects will be required to provide informed consent and meet all inclusion/exclusion criteria 
prior to being enrolled in the study listed below. 
 
a. Inclusion Criteria 
• ≥ 18 years  
• Scheduled for an angiogram/PCI  
• Planned transradial approach  
 
b. Exclusion Criteria 
• Evidence of impaired dual perfusion to the hand when tested using Allen’s 
test 
• Inaccessible radial arteries due to anatomic variations 
• Infection or other skin disorder at the puncture site 

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• Undergoing an emergent or unplanned angiogram using the transradial 
approach 
• Evidence of severe cognitive impairment or inability to understand the 
study procedures and answer follow-up questions 
• Known sensitivity or allergic reaction to materials in the study devices  
• Unwilling to participate in the study and follow all study-related 
procedures 
• Participating physician deems the subject to not be a good candidate 
• Inability to achieve radial access 
 
Subjects may be withdrawn from the study at the request of the participating physician or the 
Principal Investigator due to non-compliance with the study protocol. Subjects may also 
request withdrawal from the study at any time by notifying the Principal Investigator or 
designee without reason or prejudice to treatment. If a subject is withdrawn from the study, any 
data collected up to the point of the withdrawal will be retained in the study file. No new data 
will be collected.  
 
VI. 
Study Devices 
The medical device to be assessed in this protocol is the Softseal®-STF hemostatic pad 
(Chitogen, Inc.). The SoftSeal®-STF hemostatic pad (Chitogen, Inc.) is an FDA-approved, 
chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated 
with tissue fluids forms a gel-like synthetic clot.  
 
 In this study the RadAR EasyCLik and TR BAND® Compression devices will be used with 
the SoftSeal®-STF hemostatic pad to promote hemostasis at the puncture site.  Data previously 
collected for study purposes utilizing the VascBand™ Hemostat will also be included in the 
final analysis. All vascular compression devices are FDA approved.  
 
VII. 
Experimental Design and Methods (or Study Procedures) 
Patients will be identified for potential enrollment in this study from the cath lab schedules at 
Aurora Health Care. The potential subject medical record will be screened to determine 
eligibility. Patients found to be eligible will be considered for enrollment and may be contacted 
prior to the procedure to assess interest in participation.  See Table 1 for a schedule of study 
events. 
 
a. Screening 
Potential subjects identified from the cath lab schedule may be contacted by a 
research coordinator who will explain the study, answer questions, ascertain 
interest in participating in the study, and screen for inclusion/exclusion criteria.  
 
b. Day of Cath Lab Procedure 
On the day of the scheduled procedure, a research coordinator will approach 
potential subjects and obtain informed consent. The signed informed consent form 

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will be placed in the subject’s electronic medical record. A Barbeau test will be 
performed prior to the procedure. 
The subject will undergo their scheduled transradial catheterization in accordance 
with cath lab protocol.  Point of care activated clotting time (ACT) will be 
assessed prior to applying the hemostatic device. Demographic and medical 
history data will be collected by the research coordinator and included on the data 
collection form. Intra and post procedure data will be collected by the cath 
lab/post procedure staff. The research team will review the electronic medical 
record (EMR) and reference the procedure log along with the post procedure 
charting on the flowsheets to collect all of the data and information listed on the 
data collection forms.   
 
Hemostasis will be obtained with the SoftSeal®-STF hemostatic pad and a 
vascular compression device.  
 
The SoftSeal®-STF hemostatic pad will be applied over the puncture site and the 
vascular compression device placed to hold the pad gently in place over the 
puncture site.   
 
The physician will remove the sheath and follow manufactures recommendation 
for vascular compression device. A small amount of blood (< 0.2 mL) should 
contact the surface of the hemostatic pad. 
 
The compression device will remain in place for 30 minutes.  After 30 minutes 
the vascular compression device will have pressure gradually reduced over 5 
minutes being careful not to dislodge the SoftSeal®-STF hemostatic pad. Once all 
the air is removed, the site with the vascular compression device in place will be 
observed for an additional 5 minutes. If no bleeding is observed, the vascular 
compression device will be removed.   
 
In the event of bleeding, do not remove vascular compression device or 
SoftSeal®-STF hemostatic pad. Tighten Easyclik ™ or reinflate TR Band ®. 
Continue to monitor patient with device in place for an additional 30 minutes, 
then reattempt removal process.  If after the additional 30 minutes, SoftSeal®-STF 
hemostatic pad is saturated from excessive bleeding, initiate standard of care 
treatment. 
 
 In the event of hematoma, notify physician for additional guidance. 
 
Post procedure, staff will perform a reverse Barbeau to assess the subjects for 
vascular complications (e.g., bleeding, hematoma), hemostatic device-related 
complications (e.g., rash, ischemia), and subject report of access site pain utilizing 
the Pain Assessment Visual Analog Scale (VAS) rating on a scale of 1 to 10 prior 
to discharge. Data associated with post procedure activities will be recorded as 
indicated on the data collection tool. 
 

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c. Telephone Assessment (day 3 +/- 1 day) 
Subjects will be contacted via telephone (or in person if in-patient). The staff will 
assess for subject-reported complications, discomfort, and pain utilizing the Pain 
Assessment Visual Analog Scale (VAS) rating on a scale of 1 to 10. Results of 
this assessment will be recorded on the data collection tool. 
 
d. Post Procedure Follow-Up Visit (within 45 days) 
Subjects will be scheduled for an in-person follow-up visit. During this follow-up 
visit, staff will assess for subject-reported complications, discomfort, and pain 
utilizing the Pain Assessment Visual Analog Scale (VAS) rating on a scale of 1 to 
10. In addition, an Allen’s test will be performed to determine radial artery 
patency and overall patient satisfaction will be evaluated.    
 
e. Chart Review- 30 Day Follow up 
A medical chart review will be conducted by a member of the study team in order 
to determine if the subject returned to the hospital within 30-days of the procedure 
for a vascular-related complication associated with the radial access site.  
Table 1: Schedule of Study Events 
 
Study Procedure 
 
Screening 
Day of 
Procedure  
Prior to 
Discharge 
Telephone/ 
In person 
contact 3d, 
+/-1d 
 Office 
visit 
within 
45d 
Chart 
review 
Inclusion/exclusion  
X 
X 
 
 
 
 
Informed consent 
 
X 
 
 
 
 
Medical history/ 
demographics 
 
X 
 
 
 
 
Medication History 
 
X 
 
 
 
 
Allen’s Test 
 
 
 
 
X 
 
Barbeau/ Reverse 
Barbeau Test 
 
X 
X 
 
 
 
Perform transradial 
angiogram 
 
X 
 
 
 
 
ACT assessment 
 
X 
 
 
 
 
Application 
Hemostasis product 
 
X 
 
 
 
 
Adverse event(s),  
 
X 
X 
X 
X 
X 
Access site assessment 
 
 
X 
X 
X 
 
Patient Satisfaction 
Assessment 
 
 
 
 
X 
 
 
Statistical Considerations 

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a. Endpoints 
• 
The primary endpoint for this study is Time to hemostasis. This is defined as 
the time interval in minutes beginning with sheath removal and ending with 
removal of hemostatic device and/or observed hemostasis 
The secondary endpoints for this study are: 
• 
Rate of acute radial artery occlusion post procedure 
• 
Major access site bleeding defined as a ≥ 3 mg/dL drop in hemoglobin, or 
required blood transfusion or vascular repair to control bleeding prior to 
discharge 
• 
Minor access site bleeding defined as light bleeding without hematoma 
formation prior to discharge  
• 
Minor access site bleeding defined as light bleeding without hematoma 
formation at 30day f/u 
• 
Hematoma formation that is ≥ 3 cm in diameter prior to discharge 
• 
Pain at access site as measured on a numeric scale of 1-10 prior to discharge 
• 
Pain at access site as measured on a numeric scale of 1-10 reported at follow 
up visits 
• 
Evidence of hand/digit ischemia defined as pain, tingling, or numbness in the 
hand and/or fingers reported Pre-discharge 
• 
Evidence of hand/digit ischemia defined as pain, tingling, or numbness in the 
hand and/or fingers reported on follow-up 
• 
Readmission for vascular complication within 30-days 
• 
Bruising, swelling, or redness at or near access site reported on follow-up  
b. Statistical Hypotheses – Primary Endpoint 
The statistical hypothesis for the primary endpoint is that time to hemostasis with 
both the RadAR EasyCLik and TR BAND® Compression devices will be 
significantly reduced with the use of SoftSeal®-STF hemostatic pad. In other 
words, the use of SoftSeal®-STF hemostatic pad will allow time to hemostasis to 
be reduced from a standard 2 hours with a vascular compression device 
(VascBand™ Hemostat) to 30 minutes.  The null and alternative hypotheses for 
the primary endpoint are: 
 

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H0: Time to hemostasis with vascular compression device + SoftSeal®-
STF hemostatic pad  >30 minutes 
 
H1: Time to hemostasis with vascular compression device + SoftSeal®-
STF hemostatic pad ≤ 30 minutes  
 
c. Sample Size – Primary Endpoint 
We will analyze a convenient sample of two hundred patients with the SoftSeal®-
STF hemostatic pad and vascular compression devices (RadAR EasyCLik and TR 
BAND®) to allow for parametric statistical methods.  The first one hundred 
consecutive patients will be allocated to RadAR EasyCLik plus SoftSeal®-STF 
hemostatic pad while the following 100 consecutive patients will be allocated to 
TR BAND® Radial Compression Device plus SoftSeal®-STF hemostatic pad. 
Additional data on 100 subjects previously involved and collected for study 
purposes who received SoftSeal®-STF hemostatic pad alone and those who 
received VascBand™ Hemostat will be included in the final analysis. 
 
d. Statistical Methods 
Baseline data will be summarized between the two treatment groups; including 
demographics, clinical history, bleeding risk factors, pre-procedure and procedure 
characteristics using descriptive statistics of n, mean, standard deviation, median, 
range, and interquartile range for continuous variables and frequency and 
proportions for discrete variables. Between groups comparisons for randomized 
subjects will be conducted using Chi-square or Fisher’s Exact test (accordingly) 
for discrete variables and ANOVA or Kruskal-Wallis test for continuous 
variables.  
 
Post-procedure information will be collected and summarized between groups 
using the same descriptive statistical methods as for baseline data.  
 
Baseline and post-procedure univariate comparisons will be performed by a either 
a paired t-test or a Wilcoxon signed rank test if the variable of interest is 
continuous or by comparing proportions with either a Chi-squared or a Fisher’s 
exact test.  Differences between treatment arms will be compared with appropriate 
inferential statistical methods, depending on the outcome of interest.  When 
comparing categorical outcomes, a logistic regression will be performed, when 
comparing continuous outcomes, a repeated measures ANOVA or repeated 
measures analysis will be utilized.  
 
Adverse event and serious adverse event rates reported after randomization will 
be recorded. Adverse events and serious adverse events will be recorded for a 
period of 30 days from the time of randomization. 
 
 
All statistical analyses will be performed using Stata version 15 (StatCorp, 
College Station, TX). 
 

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e. Interim Analyses 
An interim analysis will be performed on the first 25 enrolled subjects. Any 
alterations to the study design or sample size will be made based on the results of 
the interim analysis 
 
 
 
 
 
 
VIII. Data Management 
a. Data Collection and Processing 
This research study plans to store and manage their entire dataset in Academic 
REDCap, a secure electronic data capture application that is based on Vanderbilt 
University’s REDCap application. Flexible for a variety of types of research, 
Academic REDCap provides an intuitive data-entry interface for end users into 
study-specific data collection forms associated with study events. The application 
includes real time validation rules and query management, audit trails, and the 
automated export of study data into statistical programs. The Academic REDCap 
platform is compliant with GCP predicate rule requirements and US FDA 21 CFR 
Part 11 pertaining to the use of electronic records and signatures. Aurora Health 
Care, Inc. has executed an agreement for use of the application with nearly all 
research studies conducted at Aurora. 
Access to data housed in Academic REDCap and associated with this research 
study will be limited to those individuals listed on the IRB approved research 
study, as well as caregivers from Research Analytics for administrative reasons. 
Study team members access to the system and the data itself will be limited in 
accordance with need (i.e., biostatisticians may be limited to simply export the 
dataset to statistical tools, research coordinators may be limited to entering data, 
etc.). Overall, limiting access to study team members by need should reduce the 
risk of accidental disclosure and breach of confidentiality. However, using a 
cloud-based application may incidentally raise the risk of a breach in 
confidentiality, and, therefore, Aurora Health Care, Inc. has negotiated strong 
protections with the vendor in the event of a breach of confidentiality. 
b. Data Review 
An interim monitoring plan to perform periodic checks of the data will be 
reviewed by the Biostatisticians to determine measurement aspects, data integrity 
and accuracy, consistency with study objectives and hypotheses as well as 
preliminary analysis. 
 
c. Data Retention 

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Data will be retained by the Principal Investigator in a secure location by at 
Aurora Health Care for a period of 3 years following completion of all study-
related activities and data collection. Data may be moved to an off-site storage 
location approved by Aurora Health Care during that time. The Principal 
Investigator is responsible for making sure that all essential documents related to 
the study are not damaged or destroyed. If for any reason the Principal 
Investigator withdraws his responsibility, the responsibility will be transferred to 
another individual within Aurora Health Care. 
   
 
IX. Potential Risks and Benefits 
a. Risks 
Risks associated with the study are no more than those that may be encountered 
during standard of care for patients undergoing an angiogram using the transradial 
approach. 
 
Risks associated with the use of the SoftSeal®-STF hemostatic pad include the 
following: 
 
Bleeding 
Hematoma 
Pseudoaneurysm 
Rash 
Swelling 
 
 
 
The FDA approved labeling for the SoftSeal®-STF hemostatic pad does not 
include an allergic warning. Results of testing on chitosan-derived hemostatic 
products have shown them to be non-allergenic.13 Although, some manufacturers 
of chitosan-based products recommend that patients with known allergies to shell-
fish be cautious when using these products.  
 
Risks associated with the use of the TR BAND® Radial Compression Device 
include the following: 
 
Allergic reaction 
Hematoma 
Vessel occlusion 
Bleeding 
Local venous thrombosis 
Peripheral nerve damage 
Regional pain syndrome 
 
 
Use of the Vascular compression devices is contraindicated in patients who are 
hypersensitive to the materials in the device; have an infection or other skin 
disorder at the puncture site; and/or have an abnormal Allen Test, radial supply, 
or insufficient dual arterial supply.18  

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Use of vascular compression devices for unusually long periods of time may 
result in tissue damage. It is recommended that the arterial pulse distal to the 
compression site be monitored to ensure that total occlusion has not occurred.   
 
There is also a risk of breach of confidentiality associated with being in this study. 
In order to mediate this risk, all subject data will be stored in a secure location 
that is only accessible to the principal investigator or approved designee(s). 
Subjects will be assigned a non-identifiable subject identification number at the 
time of enrollment and randomization. Information collected using the data 
collection form will be entered into an Excel spreadsheet stored on an Aurora-
owned, password protected computer. Data within the spreadsheet will only be 
identified through the subject identification number. A code list linking the 
spreadsheet data to patient information will be created and stored on a separate 
Aurora owned computer that is only available to the principal investigator or 
approved designee(s).     
 
b. Benefits  
Subjects may experience less discomfort due to an expected decrease in time to 
hemostasis.  
 
Results of this study may also be generalizable to the larger healthcare community 
by informing standard of care guidelines for obtaining hemostasis following 
transradial catheterization. Improvements in standard of care as well as cost 
savings may be realized through reductions in vascular complications associated 
with the transradial approach as well as decreased time of direct nursing care and 
length of stay.  
 
X. 
Adverse Event Reporting 
a. Definitions  
Adverse event: Any untoward medical occurrence, unintended disease or injury or 
untoward clinical signs in subjects, users, or other persons, whether or not related 
to the medical device. 
 
Serious adverse event: Any adverse event that led to 
• Death 
• Life-threatening illness or injury 
• Permanent impairment 
• Prolonged hospitalization or change to inpatient status 
• Requires medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment 
• Fetal distress, fetal death, or congenital abnormality or birth defect  
 
b. Reporting Requirements  
All observed or volunteered adverse events occurring from the time of 
randomization to 30-days post randomization will be recorded in the subjects’ 

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case histories, regardless of the study group or suspected causal relationship. For 
all adverse events, sufficient information will be obtained in order to permit: 1) 
adequate determination of the seriousness, and 2) causal relationship of the 
adverse event. Adverse events or serious adverse events found to be a result of the 
treatment regimen will be followed until resolution of the adverse event. 
 
Reportable adverse events include: 
• Excessive Bleeding 
• Hematoma 
• Ischemia 
• Infection 
• Rash at access site 
 
All adverse events and serious adverse events are to be reported to the Aurora 
Health Care Internal Review Board as outlined in the applicable policies. 
 
c. Assessment of Relationship 
The Principal Investigator is responsible for assessing the relationship of the 
adverse event or serious adverse event to the treatment.  
 
XI. Informed Consent and Privacy Plan 
In order to protect patient privacy, potential subjects will be identified by a research 
coordinator from the cath lab schedule at Aurora St. Luke’s medical center. The research 
coordinators may also receive recommendations for potential candidates from participating 
physicians. Initial contact with potential subjects will be through direct phone contact with the 
patient. Informed consent will be obtained on the day of the procedure. The research 
coordinator will approach the potential subject in a private location (e.g., outpatient room, 
office). All standard of care and study-related procedures will be performed by cath lab staff or 
research coordinators using the same protocols and processes applied to patients who are not 
enrolled in a research study. 
All study-related subject data and informed consent forms will be stored for a period of 3 years 
following the completion of all study-related activities and data collection. It will be stored in a 
secure location that is only accessible to the principal investigator or approved designee(s).  
 
XII. 
Quality Control and Assurance 
Independent monitoring of the clinical study will be performed for protocol compliance at least 
once during the study conduct period. Continuing review will be submitted to the Aurora 
Health Care IRB on at least an annual basis.   
XIII. 
Regulatory Requirements 
Approval from the Aurora Health Care IRB will be obtained to perform this study, which 
includes approval of all associated informed consent forms. All protocol modifications and 

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corresponding informed consent forms will be submitted for review and approval prior to 
implementing. 
 
The Principal Investigator is responsible for ensuring that all study personnel have appropriate 
training and experience to perform the assigned duties.  
 
The Principal Investigator will ensure that the study is performed in accordance with the 
approved protocol, and will document and report protocol deviations as required by the Aurora 
Health Care IRB policies.  
 
This study will be listed on ClinicalTrials.gov prior to enrollment of subjects. 
 
XIV. 
Publication Policy 
It is expected that the results of this study will be presented at professional meetings and 
published in peer-reviewed medical journals.  The Principal Investigator will follow the 
authorship criteria established by the International Committee of Medical Journal Editors 
(https://www.icmje.org). The study authors will disclose financial any potential conflicts of 
interest in presentations and publications.  
 
XV. 
References 
1. Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV, Kim LK, Wong SC, et 
al. Adoption of radial access and comparison of outcomes to femoral access in 
percutaneous coronary intervention: An updated report from the National Cardiovascular 
Data Registry (2007-2012). Circulation 2013;127:2295-2306. 
2. Cooper CJ, El-Sheikh RA, Cohen DJ, Blaesing L, Burket MW, Basu A, et al. Effect of 
transradial access on quality of life and cost of cardiac catheterization: A randomized 
comparison. Am Heart J 1999;138:3430-436. 
3. Sciahbasi A, Fischetti D, Picciolo A, Patrizi R, Sperdutti I, Colonna G, et al. Transradial 
access compared with femoral puncture closure devices in percutaneous coronary 
procedures. Int J Cardiol 2009;137:199-205. 
4. Kanei Y, Kwan T, Nakra NC, Liou M, Huang Y, Vales LL, et al. Transradial cardiac 
catheterization: A review of access site complications. Catheter and Cardiovasc Interv 
2011;78:840-846. 
5. Spaulding C, Lefevre T, Funck F, Thebault B, Chauvreau M, Hamda B, et al. Left radial 
approach for coronary angiography: Results of a prospective study. Cathet Cardiovasc 
Diagn 1996;39: 365-370. 

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6. Saikai H, Ikeda S, Harada T, Yonashiro O, Ozumi K, Ohe H, et al. Limitations of 
successive redial approach in the same arm: The Japanese experience. Catheter 
Cardiovasc Interv 2001;54:204-208. 
7. Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery inner 
diameter and sheath outer diameter on radial artery flow after transradial coronary 
intervention. Catheter Cardiovasc Interv 1999;46:173-178. 
8. Sanmartin M, Gomez M, Rumoroso JR, Sadaba M, Martinez M, Baz JA, et al. 
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