Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)
Phase: NA
Conditions: Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-Induced Bleeding, Coronary Artery Disease
Sponsor: VA Long Beach Healthcare System

 
 
 
 
 
 
A PROSPECTIVE RANDOMIZED STUDY COMPARING THE INCIDENCE OF RADIAL ARTERY 
OCCLUSION (RAO) AND THE TIME TO HEMOSTASIS (TTH) WHEN USING A HEMOSTASIS BAND 
ALONE AND IN CONJUNCTION WITH A DISC COMPRISED OF POTASSIUM FERRATE (STATSEAL 
ADVANCED) FOLLOWING TRANSRADIAL CATHETERIZATION. 
 
Study Sponsor:   
A Physician Initiated Study  
 
Principal Investigator: 
Arnold Seto, MD, MPA 
Cardiology Division 
Veterans Medical Center Long Beach 
 
 

 
Investigator Signature Page 
Study Title: 
A prospective randomized study comparing the incidence of Radial Artery 
Occlusion (RAO) and the Time To Hemostasis (TTH) when using a hemostasis band 
alone and in conjunction with a disc comprised of Potassium Ferrate (StatSeal 
Advanced) following transradial Percutaneous Coronary Intervention (PCI). 
 
 
Study Center: 
________________________________________________ 
Name of Participating Center 
 
 
We, the undersigned, have read and understand the protocol specified above and agree on its 
content.   We agree to perform and conduct the study in conjunction with the other named 
participating centers, and as described in the protocol according to the Declaration of Helsinki, 
and all pertinent individual country laws and regulations. 
 
 
_____________________________________________________     ______________ 
Principal Investigator  
 
 
 
 
 
 
Date 
___________________________________________, MD 
Principal Investigator Printed 
If additional investigators are participating in this study, please indicate names below: 
 
_____________________________________________________     ______________ 
Additional Investigator (Print Name & Initial)  
 
 
 
 
Date 
 
 
_____________________________________________________     ______________ 
Additional Investigator (Print Name & Initial)  
 
 
 
 
Date 
 
 

 
 
Table of Contents 
I. 
INTRODUCTION, BACKGROUND & RATIONALE 
II. 
DESCRIPTION OF STUDY DEVICE   
III. 
STUDY OBJECTIVES   
IV. 
STUDY DESIGN AND  METHODOLOGY 
V. 
STUDY ACTIVITIES AND GUIDELINES 
VI. 
STUDY STATISTICAL PLAN   
VII. 
ADVERSE EVENTS   
VIII. 
DATA MANAGEMENT   
IX. 
ETHICAL, REGULATORY AND ADMINISTRATIVE REQUIREMENTS   
X. 
RISK BENEFIT ANALYSIS  
XI. 
REFERENCES   
APPENDICES 
 
 
 
 

I.   INTRODUCTION, BACKGROUND & RATIONALE 
Over the past decade, transradial access (TRA) for invasive cardiac catheterization procedures 
has gained significant popularity in Europe, Canada, South America, Japan, and other sites 
outside of the United States where TRA is used in more than 60% of the cases.1 The most 
compelling reason for adopting TRA is the increased patient safety that results from the 
potential elimination of access site bleeding and vascular complications. In addition, TRA is 
associated with early sheath removal, improved patient comfort, faster recovery, and lower 
costs in comparison with transfemoral access.2-4 TRA provides the ability to perform a broad 
range of diagnostic and interventional cardiovascular procedures. In the USA, TRA 
catheterization procedures are gaining significant momentum with a significant growth from 2% 
in 2007 to approximately 15% in 20115, and an estimated 30- 35% in 2015.  Moreover, with 
increased availability of training opportunities the TRA utilization rate is expected to grow to 
50% or more in the next 2 – 4 years. 
One important advantage of TRA is that the vascular sheath is always removed at the end of 
procedure regardless of the intensity of anticoagulation or antiplatelet therapy. Multiple methods 
for radial hemostasis have been described. Gentle manual compression with one or two fingers 
at the arteriotomy site is an effective method. Alternatively, a rolled piece of gauze can be 
placed longitudinally at the arteriotomy site and wrapped with an elastic bandage.  These low 
tech methods have been mostly abandoned in favor of mechanical devices that apply 
compressive pressure to the arteriotomy site via a balloon mounted on a wrist band.  These 
‘Hemostasis Bands’ are inflated with air in a somewhat arbitrary manner and often require 
prolonged hemostatic pressure. The disadvantage of these methods is the complete interruption 
of arterial flow because of the inability to gauge the hemostatic pressure applied, regardless of 
the methodology developed for their use. It has been demonstrated that when occlusive 
pressure is maintained for a period longer than two hours radial artery occlusion (RAO) occurs 
more often.6,7  In fact, RAO after TRA procedures is not uncommon and occurs in approximately 
5-10% of cases, and is accurately described as a function of time and pressure. 
Incidence RAO  =  f (Time, Pressure) 
In order to minimize the occurrence of RAO, Pancholy introduced the “patent” non-occlusive 
hemostasis technique, designed to address the pressure side of the RAO equation8. With this 
technique, a Hemostasis band is placed and a pulse oximeter is attached to the ipsilateral 
thumb. Then, while the sheath is being removed, the balloon is fully inflated with approximately 
15-18 cc of air to completely occlude the radial artery. Subsequently, the device is slowly 
deflated while occlusive manual pressure is applied to the ulnar artery located at the Guyon’s 
canal, lateral to the pisiform bone.  Patent hemostasis is achieved when oximetry becomes 
positive and a plethysmographic waveform can be visualized. This technique assures the 
presence of antegrade flow in the radial artery during hemostasis.   Later in recovery, small 
amounts of air can be periodically released, until the device is completely deflated and then 
removed. Using this technique, late occlusion rates can be reduced to approximately less than 
5%.8 
THE CLINICAL NEED  
However, despite Pancholy’s technique, meticulous patent hemostasis with careful 
ascertainment of adequacy of the antegrade radial flow to the hand is performed in less than 

50% of cases and about a third of transradial operators are unaware of the RAO rates in their 
own practices.9  Even when those methods10, which are recognized as being labor intensive, 
result in an appropriate pressure being applied, hemostasis bands are typically left in place for 4 
hours or more in patients having undergone PCI, due to the effects of anticoagulation and the 
risk therein of hematoma at the access site.  Because this method is labor intensive, many busy 
PCI programs forego this methodology in favor of alternatives, using palpable pulse methods or 
arbitrary inflation formulas in an attempt to achieve patent flow.  In addition, the management of 
the band often requires actions of nursing personnel at locations outside the catheterization lab, 
resulting in an increased risk for complications from diminished expertise of those personnel as 
compared to the cath lab staff.   And, even when all goes well, the impact on patient throughput 
and productivity when up to 4 hours of post procedure monitoring is required solely due to 
hemostasis band management is significant, resulting in delayed or postponed procedures, 
delayed discharges, additional staff expense, and other care related costs. 
 
One method to attack these deficiencies in current program practice is to attack the time 
component of the hemostasis equation.  In doing so, it is hypothesized that if radial artery 
compression time can be shortened to 40 minutes or less, the following could result:  improved 
catheterization lab efficiency, greater patient satisfaction and lower complication rates, including 
RAO, may be improved.   As concerns improved cath lab efficiency, a system that standardizes 
compression technique and shortens compression time to that which is fully under the 
supervision and care of cath lab holding room personnel, will also eliminate the variability of 
recovery staff needing to manage the hemostasis band / site, and complications typically 
associated with patient management being carried out in multiple settings within the hospital.   
To summarize, the potential advantages of a hemostasis system for PCI incorporating the 
benefits of the StatSeal technology used in combination with a hemostasis band as compared to 
a hemostasis band alone may include: 
▪ 
Decreased radial artery compression times, aka Band In Place (BIP) time.   
▪ 
Decreased incidence of RAO complications at discharge, or 24 hours, whichever occurs 
first 
▪ 
Decreased incidence of other complications associated with TRA, such as hematoma, 
bleeding, and oozing. 
▪ 
Elimination or reduction in the need for additional equipment, such as Doppler units, 
plethysmographs and pulse oximeters to assess hemostasis band efficacy  
▪ 
Facilitate arterial site management to the more specialized catheterization lab 
staff/personnel that are better trained to recognize complications that occur during (BIP) 
band in place time. 
▪ 
Decreasing the workload to the staff by virtue of shortened band in place times and 
improve procedural throughput. 
▪ 
Facilitate greater patient comfort resulting from decrease band in place time and faster 
wound healing. 
To do so, the effects of anticoagulation used during a PCI must be taken in to account.    
II. 
DESCRIPTION OF THE STUDY DEVICE:  
Recently, a new compound – potassium ferrate, in combination with a hydrophylic polymer 
which is formed in to a disc when compressed - has been used in conjunction with hemostasis 
bands to shorten compression times.  This product (trade name StatSeal Advanced) is an FDA 

approved product comprised of a topical hydrophilic polymer and potassium ferrate disc, [Photo 
1] formed by compression of the compound.  
 
 
 
Photo 1:    StatSeal Advanced Disc 
 
When in the direct contact with even a small amount of blood, the compound forms an occlusive 
seal through simultaneous iron-mediated agglomeration of blood solids/proteins and rapid 
dehydration of the blood.  Seal formation is independent of the clotting cascade, facilitating 
sealing regardless of anticoagulation / antiplatelet status of the patient.    Following cessation of 
pressure being applied to the site, the remnants of StatSeal form what resemble a ‘scab’, and 
remains in place for 24 hours, covered with a band-aid or Tegaderm patch.   
In clinical testing using a protocol refined at the University of Miami Miller School of Medicine, 
the use of this compound in conjunction with commercially available hemostasis bands has 
demonstrated the potential to significantly shorten the time required to achieve hemostasis 11,12.  
Further, these results demonstrated the ability to achieve hemostasis using StatSeal with 
similar, or fewer complications when compared to standard methods, and did so regardless of 
the patient’s anticoagulation status.  
INDICATION FOR USE 
StatSeal Advanced is a commercially available product in the United States, and is indicated for 
use on patients in whom the radial artery has been used to gain vascular access for a 
cardiovascular procedure.   
DEVICE STORAGE AND ACCOUNTABILITY 
StatSeal Advanced is provided in a sterile, foil pouch to protect it from humidity / moisture.  As 
with most medical products, it should be stored in a cool, dry, secure environment.  StatSeal 
Advance will be provided at no charge by the manufacturer for use in the study.  
Damaged devices will be returned to the manufacturer (Biolife, LLC, Sarasota,FL). All unused 
devices may be retained by the site for continued use, if they so choose. 
  
 
 

III. 
STUDY OBJECTIVE(S) 
The primary objectives of this study are to evaluate the performance of StatSeal Advanced used 
in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative 
to: 
1. the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, 
whichever occurs first, and; 
2. the Time to Hemostasis (TTH) 
HMS is defined as the Hemostasis Management System employed based on which group the 
patient is randomized to (either SSA or TRB). 
Radial Artery Occlusion is defined as the absence of flow to the hand based upon 
plethysmography – pulse oximetry (Pleth-Ox) performed using the Barbeau scale. 
Time to Hemostasis (TTH) is defined as the time period required to achieve hemostasis, more 
specifically the time during which the subject is wearing the HMS system and the system is 
active, e.g. applying compressive force to the access site.  For clarity, the time period that a 
HMS is left on the wrist while totally deflated is not considered as part of the TTH time. 
 
IV. 
STUDY DESIGN AND METHODOLOGY 
STUDY DESIGN 
This study is a physician initiated, prospective, observational, two arm, randomized study to be 
performed at up to four experienced ‘Radial First’ centers. A minimum of 120 patients having 
undergone successful radial catheterization will be enrolled in the study, 60 in each arm.  
Enrollment with continue at each site on discretion of the investigators until each center enrolls 
a minimum of 30 patients, or a maximum of 180 patients are enrolled.    Clinicians will perform 
the catheterization in accordance with local standard practice, with a minimum of 5,000 units of 
unfractionated heparin for anticoagulation.  
 
STUDY METHODS; 
Patient Selection CriteriaStudy subjects will be identified in the catheterization laboratory 
holding area and asked to sign the informed consent prior to their catheterization procedure 
before the administration of sedative agents. 
Inclusion Criteria: 
• 
Patient undergoing diagnostic angiography or PCI via the radial artery 
• 
Patients with a Barbeau test prior to the procedure showing pattern A,B,or C. 
 
Exclusion Criteria: 
Candidates for this study will be excluded if any one of the following criteria is true. 
• 
Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed). 
• 
Use of an anticoagulant other than unfractionated heparin or bivalirudin. 

• 
Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein 
inhibitors are acceptable. 
• 
Any active treatment with oral anticoagulants continued during course of procedure. 
• 
Presence of arteriovenous dialysis fistula in the ipsilateral arm. 
• 
Any physical deformity or trauma / injury of either wrist that would prevent proper 
placement or function of the hemostasis band. 
• 
Raynaud’s syndrome or known peripheral vascular disease of the forearm. 
• 
Mental incompetence or inability to follow the instructions to complete the study. 
• 
History or presence of Radial Artery Occlusion. 
• 
Barbeau test showing Pattern D.  
• 
Patients undergoing catheterization from the femoral or ulnar artery approach. 
• 
Cardiogenic shock or any clinical instability as assessed by the physician performing the 
procedure. 
Transradial Catheterization Procedure 
Transradial Cardiac Catheterization will be performed according to local practice standards with 
use of a sheath diameter of up to 6 Fr.  (A 7Fr-in-6 Glidesheath Slender®, with an outer 
diameter of 6Fr is defined as a 6F sheath and is allowed.)  In accordance with current 
recommendations for minimizing radial artery occlusion, a minimum of 5,000 units of 
unfractionated heparin, or therapeutic bolus of bivalirudin, will be administered to all patients 
enrolled in the study.  
Patients will have their activated clotting time measured at least 5 minutes following the initial 
dose of anticoagulant, although every patient receiving 5,000 units of heparin will be eligible for 
the study. Vasodilators (nitroglycerin, verapamil) will be administered in accordance with local 
practice. 
Timing of Subject Enrollment 
A subject will be consented into the study prior to the administration of sedation prior to the 
procedure, and randomized at the conclusion of a successful procedure (after all 
anticoagulation and antiplatelet medication decisions have been made), at which time 
placement of the assigned HMS device will occur. Eligibility for the study will be assessed at this 
time and the subject will have to meet all of the inclusion criteria and none of the exclusion 
criteria. 
Randomization will be performed by means of sealed envelopes in randomization blocks of 30. 
Each envelope will be labeled by patient number containing device designation.    Device 
designation in the envelopes will be random in occurrence.  When a patient is officially enrolled 
(after successful completion of a TRA procedure), the envelope corresponding to that patient 
number in the Study Patient log will be pulled, opened, and the assignment revealed. 
Each of 4 sites will be allotted an initial block of 30 envelopes, and sets of backup blocks of 30 
envelopes.  On the discretion of the site principal investigator and the lead principal investigator, 
enrollment may continue until each site enrolls 30 patients. The maximum enrollment at any one 
site shall not exceed 50% of the total study enrollment, or 90 patients.  
 
End of Study Status / Effect of Withdrawals: 
A subject will have completed the study when one of the following events is documented:  

1. The patient is successfully enrolled, treated with a HMS, and completes all required 
follow up tests. 
2. A subject withdraws consent to participate. Patients who withdraw from the study will be 
replaced and excluded from data analysis. 
 
 
Protocol: 
Control patients:  Patients will have a TR band applied over the arteriotomy site and inflated with 
15-18ml of air.  After aspirating and clearing the contents of the sheath, the radial sheath 
will be removed.  The TR band will be deflated until bleeding occurs, and 2 ml of air will 
be reintroduced to provide hemostasis.  Patent hemostasis will be documented with 
plethysmography and oximetry as decribed below within 5 minutes after band 
application and removal, and within 30 min of discharge or after 24 hours.  The TR band 
will be left inflated and in place for 2 hours following the procedure for all patients 
(regardless of diagnostic or PCI procedure), after which deflation attempts will 
commence. 
 
Statseal Protocol: Patients will have a Statseal Advance (SSA) disc applied after withdrawing 
the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc 
position.  The TR band will be applied over the SSA disc with the center of the balloon 
(the green dot) over the center of the SSA disc.  The TR band will be inflated with 8cc of 
air (which is typically occlusive pressure), and the sheath removed.  No deflation will 
occur immediately.  After 20 minutes of pressure, 3 cc of air will be removed from the TR 
band. After an additional 20 minutes (40 minutes after procedure), the TR band will be 
completely deflated, and the TR band left in place. After an additional 20 minutes (60 
minutes after procedure) the TR band will be removed. 
 
 
 
 
 [rest of page intentionally blank] 
 

STUDY OVERVIEW GRAPHIC 
 
Cath

 
V. 
STUDY ACTIVITIES & GUIDELINES 
Inspection Prior to Use 
Prior to initiating any study activities, inspect the HMS devices for any damage.  Do not use any 
device that appears compromised or damaged. 
Required Accessories for each experiment 
▪ 
Hemostasis Band (TR Band, Terumo, Inc.) 
▪ 
StatSeal Advanced disc (if randomized to test group) 
▪ 
Pulse oximeter  
ACTIVITIES AND ASSESSMENTS 
Informed Consent: 
Subjects must have read the contents of the written informed consent document, had all 
questions regarding the study adequately answered by study staff, and signed and dated the 
document prior to any study related activities.  See Appendix 1 for a sample of the Informed 
Consent document. 
 
Definitions of Baseline and Procedural Variables: 
Smoking: Active smoking or >20 pack year tobacco history. 
Diabetes: Hgb A1C >6.5% or active medical treatment for diabetes. 
Hypercholesterolemia: LDL >130 or on treatment with antilipemic agents. 
Hypertension: >140/80 or on medical treatment for hypertension. 
Diagnostic procedure: Involving diagnostic catheters only. 
Interventional procedure: Involving an interventional wire and therapeutic ACT typically >200, 
including for fractional flow reserve measurement where a stent is not placed. 
Single wall puncture: Use of micropuncture wire and anterior wall puncture only. 
Double wall puncture: Use of double wall puncture and sheath withdrawal technique. 
Number of forward attempts: Number of forward advancements of the needle required to obtain 
access (not number of separate punctures of skin). 
Procedure Start Time: Time when lidocaine is administered, prior to first puncture attempt. 
Procedure End Time: Time when sheath is removed. 
 
Test methodology:  

All Pleth-ox testing will be done by qualified personnel with results classified according to 
Barbeau test pattern classifications. [Barbeau, et al.  Evaluation of ulnopalmar arterial arches 
with pulse oximetry and plethysmography; comparison with the Allen’s test in 1010 patients.  
Am Heart Journal; 2004; 147:489-493] 
At the start of the TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam 
will be performed for all patients and recorded on the CRF.   Ulnar compression will be applied 
to confirm that the radial artery is patent.  Patients with a type D pattern exam will be excluded 
from the study. 
At the conclusion of a successful transradial procedure, the patient will be randomized to either 
SSA or TRB, each device applied per protocol & IFU.  
Following placement of the HMS system, Pleth-Ox exams will be performed at the following time 
points with results recorded in the CRFs. 
• 
Within 5 minutes of initial HMS placement 
• 
In the SSA (StatSeal Advanced) group, within 5 minutes of the first partial deflation (20 
minutes after initial placement). 
• 
Within 5 minutes of full deflation of the HMS in both groups 
• 
Within 30’ of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. 
 
 

VI. 
STUDY STATISTICAL PLAN: 
This is a physician initiated, prospective, randomized, two-arm study, to be conducted at up to 
four experienced ‘Radial First’ centers with the principal investigator having a (minimum) ten 
case experience using StatSeal Advanced. 
The sample size of 120 patients is estimated to have 90% power to detect an average 
difference in time to removal of the TR band of 60 minutes between the SSA and TRB groups, 
using a relatively large standard deviation of 100 minutes and a two-sided alpha of 0.05. 
Descriptive summary statistics will be presented for all study variables.  Continuous variables 
will be displayed as means with standard deviations and medians with 75th and 25th percentiles.  
Categorical variables will be summarized as frequencies with their respective percentages with 
two-sided 95% exact confidence intervals of the percentages. Statistical comparisons for 
continuous variables will be performed using the Student’s t test or Mann-Whitney U test, as 
appropriate. Comparisons for categorical variables will be performed using the Chi square test 
or Fisher exact test, as appropriate. A two-sided P value of 0.05 will be considered statistically 
significant. 
Categorical variables will include, but are not limited to: 
▪ 
Percent of patients in each arm with total TTH of 60 minutes or less. 
▪ 
Percent of patients in each arm with TTH of 40 minutes or less without complication. 
▪ 
The percentage of patients in each arm with bleeding, oozing or hematoma during TTH, 
further delineated by the EASY bleeding and hematoma classification attached. 
▪ 
Percent of patients in each arm with RAO at each /all follow-up points. 
▪ 
Percent of patients in each arm with radial patency as tested with Pleth-ox at each 
designated test time point. 
 
Primary Efficacy Outcomes: 
In each arm the: 
▪ 
Total Time to Hemostasis (TTH), defined as the total time the HMS applies compressive 
force until successful hemostasis is achieved without complication. 
 
Secondary Efficacy Outcomes: 
In each arm the: 
▪ 
Percent of patients free from radial artery occlusion at discharge or at 24 hours, 
whichever occurs first. 
▪ 
Percent of patients with Barbeau test patterns A,B,C,D at initial application of the HMS 
▪ 
Percent of SSA patients with Barbeau test patterns A,B,C,D after 20’ of HMS time. 
▪ 
Percent of patients with Barbeau test patterns A,B,C,D at full deflation of the HMS. (40’ 
for SSA group; per protocol in the TRB group)  
▪ 
Percent of patients with Barbeau test patterns A,B,C,D at discharge or at 24 hours, 
whichever occurs first.  
▪ 
Percent of patients in whom successful hemostasis is achieved in one hour or less. 
 
Primary Safety Outcome: 
Any adverse event /  complication at the vascular access site (e.g. Class III, IV, or V Hematoma, 

other bleeding) at any time pre-discharge / at 24 hours other than RAO (as defined in the 
protocol). 
Secondary Safety outcomes: 
Any minor adverse event / complication (e.g. class I or II Hematoma) at the the vascular access 
site any time pre-discharge / at 24 hours other than RAO (as defined in the protocol). 
Any complication (e.g. those typically associated with a PCI procedure) other than at the 
vascular access site at any time pre-discharge / at 24 hours other than RAO (as defined in the 
protocol). 
VII. 
ADVERSE EVENTS: 
Reports of all adverse events will be made and recorded for the duration of the study, and 
categorized as specific to those complications associated with radial access, such as 
hematoma, bleeding, RAO, and other vascular access complications, or those more typically 
associated with PCI, such as Major Adverse Cardiovascular Events (MACE). 
Adverse events will be recorded on CRFs and adjudicated by the site Principal Investigator as 
to their severity and whether or not directly, indirectly, or not connected to the study HMS 
devices, and forwarded to the Data Center for entry in to the database. 
DEFINITIONS: 
Adverse Event  
Any clinically relevant event that occurs during the performance of the study that puts the 
Subject at additional risk of injury, whether foreseen or not, and requires additional care beyond 
that expected as a result of the study. 
Adverse Device Event 
An adverse event related to the use of the device. This includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, or operation, or any malfunction of 
the device. This definition also includes any event resulting from user error or from intentional 
misuse of the device by the investigator. 
Serious Adverse Event  
A serious adverse event (SAE) is defined as an adverse event that:  
• 
Led to death,  
• 
Led to a serious deterioration in health that either,  
o Resulted in a life-threatening illness or injury, or  
o Resulted in a permanent impairment of a body structure or a body function, or  
o Required in-patient hospitalization, or  
o Resulted in medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body function.  
 
 
Note: This includes device deficiencies that might have led to a serious adverse event if 
(a) suitable action had not been taken or (b) intervention had not been made or (c) if 
circumstances had been less fortunate.  
 
VIII. 
DATA MANAGEMENT 
 

Data Collection Process 
Data will be collected in an anonymous form using case report forms for each subject.  CRFs 
will be transmitted to the data center for entry in to the database.  Data may be collected by 
clinical research personnel assigned to the study, under the supervision of the investigator.   
 
Data Confidentiality 
Subject data will be collected in an anonymous form.  Each site will keep a confidential, site – 
only log of enrolled patients connecting their identity to a coded subject identifier.  Each subject 
will be entered on the log along with procedure date and will be assigned a patient study 
number comprised of the site number and sequential subject number enrolled.  This coded 
number will be used in the CRFs.   For example, John Q Doe, the 12th patient enrolled at site 
number 2, will be assigned study identifier 002-012.  All activities will be performed in 
compliance with HIPPAA and Good Clinical Practice standards  
Data Center 
CRFs or coded anonymized data will be forwarded to the Data Center at the Long Beach VA 
Medical Center, checked for completeness, and entered in the Database as received.  
Incomplete forms will be returned to the study site for completion.  Electronic submission of 
Data may be employed, but is not required.  
See the “Study Statistical Plan” for a description of the plan. 
 
IX. 
ETHICAL, REGULATORY & ADMINISTRATIVE REQUIREMENTS 
The devices being studied in this clinical plan, and the tests performed under it, are approved 
for marketing by the US-FDA for use as described and have been in use for TRA procedures at 
the participating institutions.  FDA approval of the study is not required.  No part of the study 
uses any device or test that is considered investigational.  
Investigational Review Board Approvals.   
Data from this study may be used for publication in the scientific literature, and therefor IRB 
approval is required.  No patient may be enrolled until IRB approval is granted, and an Informed 
Consent approved by the IRB is signed by the subject. 
 
Protocol Adherence and Amendments 
Investigators will be required to adhere to the protocol requirements.  Deviations or violations of 
the protocol may result in dismissal from the study. 
 
Informed Consent 
Each subject in the study must sign the informed consent agreeing to participation. 
 
Alternatives to Participation 
As a voluntary randomized study, the patient’s alternative to participation is primarily to the local 
standard of care, typically involving the TR band, used per local protocol (typically 1-3 hours of 
application).  SSA devices may be used outside of the study depending on local practice and 
availability. 

 
Study Activities 
The Investigator is required to perform the study in accordance with the protocol and to use the 
HMS per the instructions for use. 
Follow-Up 
There is no requirement for the subjects taking part in the study to be seen or examined for any 
follow up relative to the study following completion of activities described herein.  
CRFs 
CRFs will be completed for each subject.  See Appendix 1 for the CRFs. 
Records and Retention 
Copies of all records will be retained by the investigator at each site for 2 years. 
(Model) Patient Informed Consent 
See Appendix 2 for a model of the informed consent. 
Communication with the Principal Investigator: 
All communication regarding the study should be routed directly to the Principal Investigator.  
Copies of all correspondence regarding the study should be maintained in the Site Investigator 
study file. 
Declaration of Helsinki & HIPPAA 
The Principal Investigator will ensure that this study is performed in conformity with the 
Declaration of Helsinki, HIPPAA, and all local and national regulations. 
Investigator Responsibilities 
• 
Sign and adhere to the Investigator Agreement  
• 
Sign and adhere to all of the required elements of the Clinical Protocol  
• 
Resolve queries in a timely manner  
• 
Participate in Investigator meetings, if scheduled 
• 
Comply with the Declaration of Helsinki  
• 
Obtain written Informed Consent from each study participant before any study specific 
procedures are performed  
• 
Complete all required case report forms (CRFs) for each subject  
• 
Comply with all applicable regulations and codes of approvals from the site IRB and 
other Regulatory Authorities  
• 
Notify the Principal Investigator of personnel changes that may affect the study protocol  
• 
Retain all records and study files as required, after which the files may be destroyed.  
• 
Allow direct access to source data/documents, including patient records, in case of 
monitoring, auditing and/or inspection by the IRB and/or other regulatory authority 
bodies. 
 
X. 
RISK BENEFIT ANALYSIS 
General Risks and Presumed Benefits: 
Application of a HMS in a setting absent an actual radial arteriotomy presents negligible risk to 
the subject.  The only foreseen risk would be leaving an inflated band in place for an extended 
period of time.  This risk is negligible provided the protocol is followed.  An action of this nature 
would be considered a protocol violation. 

Patients assigned to the SSA group may enjoy less discomfort from the shorter length of time 
that the HMS is in place.   Patient in the TRB group should experience no difference in benefit 
than those having been treated with a traditional HMS prior to the study. 
The potential benefit of subject participation is gratification from making a contribution to science 
helping to demonstrate the effectiveness of a new clinical method to achieve hemostasis 
following a radial artery procedure.   This new method could potentially provide a safer, more 
efficient, and more effective HMS for clinicians to use in treating patients undergoing the radial 
approach for cardiovascular procedures.   
Risks related to Hemostasis Bands: 
Currently marketed hemostasis bands have been associated with complications such as, but 
not limited to, skin irritation, radial artery occlusion, hematoma, pseudoaneurysm, failure to 
achieve hemostasis, and general wrist discomfort.   
Risks Specific to the Study Device: 
There are no known risks specific to the study device. 
Risk Mitigation: 
Every effort will be made to mitigate risks in this Study.  Those efforts include requiring 
investigators to be highly experienced Radialists, practicing at Radial First centers, and have 
used the study device in a minimum of ten cases.  
 
Clinical monitoring will occur in real time to ensure the accurate collection and reporting of data, 
and ensure that the Site is in compliance with the clinical protocol requirements that mitigate risk 
such as patient entry criteria, use of the study device in accordance with instructions, and 
compliance with study test procedures and methods.  
 
XI. 
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to percutaneous coronary intervention: historical perspective, current concepts, and 
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2. 
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3. 
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6. 
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7. 
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APPENDICES: 
Appendix 1: 
Sample Informed Consent 
Appendix 2: 
CRF’s