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

 
 
 
 
 
 
A PROSPECTIVE RANDOMIZED STUDY COMPARING THE TIME TO HEMOSTASIS (TTH) AND 
SAFETY OF USING A HEMOSTASIS BAND ALONE AND IN CONJUNCTION WITH A POTASSIUM 
FERRATE PAD (STATSEAL ADVANCED) FOLLOWING TRANSRADIAL CATHETERIZATION. 
 
 
Principal Investigator: 
Arnold Seto, MD, MPA 
Cardiology Division 
Veterans Medical Center Long Beach 
 
 
 
NCT04046952 
Original Document Date 4/2/2019 

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 
Transradial access (TRA) for invasive cardiac catheterization procedures has gained significant 
popularity around the world compared with the transfemoral access.  The 2015 European 
Society of Cardiology guidelines have given transradial access its highest recommendation 
(Class I A) over femoral access.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 507 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 described6. Prolonged 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, highly variable methods have been mostly abandoned in most countries in favor of 
inexpensive 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 and apply 
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.7,8  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 
2-4 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 address these deficiencies reduce the time of hemostatic compression.  If radial 
artery compression time can be shortened to 60 minutes or less, the following could result:  
improved catheterization lab efficiency, greater patient satisfaction and lower complication rates, 
including RAO, may be improved.   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. 
In our recent pilot study of 180 patients11 comparing the TR band (TRB) with and without the 
Statseal (SS), successful TRB deflation occurred at 43 ± 14 minutes with SS and 160 ± 43 
minutes without SS (p<0.001).  Minor hematomas occurred in 9 (10.3%) of TRB patients and 16 
(17.2%) of SS patients (p=0.20). Radial artery occlusion occurred in 2% of patients in the SS 
group (p=NS).  Outpatients randomized to SS were discharged on average 51 ± 83.5 minutes 
earlier than control. 

Thus, the Statseal was demonstrated to facilitate a rapid deflation protocol with the TRB, 
resulting in an earlier discharge, without evidence of significantly increased complication of 
hematomas or radial artery occlusion.  However, critiques of these results suggested that the 
protocol of different times for first complete TRB deflation attempt (40 minutes with SS and 180 
minutes without) biased the outcome of the study, even though the times were based on current 
practice.   In addition, there was concern that the study was not sufficiently large to detect a 
potential increased risk of the rapid deflation protocol with SS. 
The present study is designed to address these concerns by having an identical time to first 
deflation of 60 minutes between the two groups, and have a larger sample size to detect any 
excess in the risk of hematoma or radial artery occlusion. 
 
II. 
DESCRIPTION OF THE STUDY DEVICE:  
Recently, a new compound – potassium ferrate, in combination with a hydrophilic 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.   
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 (SS) as compared to the TR Band without SS (TRB) relative to: 
1. the Time to Hemostasis (TTH)    
2. the incidence of access site or forearm hematoma  
3. peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs 
first, and; 
 
Time to Hemostasis (TTH) is defined as the time period required to achieve hemostasis, more 
specifically the time during which the TRB is applying compressive force to the access site. The 
time period that a TRB is left on the wrist while totally deflated is not considered as part of the 
TTH time. 
Hematoma are defined according to the EASY scale.  (EASY Classification I-V, ranging from 
<5cm [I], 5-10cm [II] , >10cm to forearm [III], above elbow [IV] and causing ischemia [V]).   
Radial Artery Occlusion is defined as the absence of flow to the hand based upon 
plethysmography – pulse oximetry (Pleth-Ox) performed using the reverse Barbeau test. 
Unlike the pilot trial of this device, the present study will have an identical time to first deflation 
of 60 minutes between the two groups, and have a larger sample size to detect any excess risk 
of hematoma or radial artery occlusion.  The study may also help demonstrate a relatively low 
rate of radial artery occlusion with a rapid deflation protocol, even at lower doses of 
unfractionated heparin than currently recommended.  
 
IV. 
STUDY DESIGN AND METHODOLOGY 
STUDY DESIGN 
This study is a physician initiated, prospective, observational, two arm, randomized study to be 
performed at experienced ‘Radial First’ centers. A minimum of 100 patients having undergone 
successful radial catheterization will be enrolled in the study, 400 in each arm.  Enrollment with 
continue at each site on discretion of the investigators until at least 100 patients are enrolled, 
with each center contributing a minimum of 50 patients.    Clinicians will perform the 
catheterization in accordance with local standard practice, with no minimum amount of 
anticoagulation required.  
 
STUDY METHODS; 
Patient Selection Criteria Study 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 a hemostasis method or device besides the TR Band.  
• 
Patients undergoing catheterization from the femoral, brachial, ulnar, or distal radial 
(snuffbox) artery approach. 
• 
Use of an anticoagulant other than unfractionated heparin or bivalirudin. 
• 
Any use of glycoprotein inhibitors or cangrelor.  
• 
Use of sheathless guides. 
• 
Any anticipated need for continued anticoagulation post-catheterization, including 
extended bivalirudin infusion. 
• 
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. 
• 
Inability of the patient to personally consent for the study. (no surrogate consent) 
• 
History or presence of Radial Artery Occlusion. 
• 
Barbeau test showing Pattern D.  
• 
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.)   
Patients will have their activated clotting time measured prior to sheath removal and at least 5 
minutes following the initial dose of anticoagulant.  Additional activated clotting time 
measurements for PCI would be expected as part of routine practice but not recorded. 
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 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 100. 
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 the sites will be allotted an initial block of 100 envelopes, with sets of additional blocks 
of 100 envelopes as needed.  On the discretion of the site principal investigator and the lead 
principal investigator, enrollment may continue until each site enrolls 50 patients. The maximum 
enrollment at any one site shall not exceed 50% of the total study enrollment.  
 
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 TRB, and completes all required 
follow up tests. 
2. A subject withdraws consent to participate. Patients who withdraw from the study will 
have their data included to the extent allowable by law. As all study related procedures 
are expected to be completed on the day of the procedure or day after, subject 
withdrawal is not considered likely. 
 
Protocol: 
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.  
 
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 described 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 60 minutes following the procedure for all patients 
(regardless of diagnostic or PCI procedure), after which full deflation attempts will 
commence. 
 
Statseal Protocol: Patients will have a Statseal Advance RAD (SS) 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 SS disc with the center of the 
balloon (the green dot) over the center of the SS 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 40 minutes (60 minutes after procedure), the TR band 
will be completely deflated. 
 
For both groups of patients:  
Aside from the 3 cc partial deflation at 20 minutes in the SS group, all other TR band deflations 
should be attempts to completely deflate the device.  Should there be evidence of bleeding 
during deflation (pulsatile blood flow, rebleeding, ooze, hematoma formation), the TR band is to 
be re-inflated only to the extent required to control bleeding, and radial artery patency checked 
with plethysmography.  Subsequent attempts at full TR band deflation should occur regularly 
and no less often than every 15 minutes.  

 
 
Pleth-Ox testing of radial artery patency (Reverse Barbeau): 
 
Following hemostasis, a pulse oximeter should be placed on tip of the ipsilateral thumb or index 
(2nd) finger and left there for successive observation of pulsatile waveforms.  Compress both the 
ulnar and radial arteries proximal or distal to the TR band to confirm sufficient pressure is 
present to close the artery. Release of pressure to the radial artery while maintaining ulnar 
compression will result in a normal distal waveform, diminished waveform, or absent waveform.  
 
Absence of plethysmographic waveform is indicative of interruption of radial artery flow from 
radial artery occlusion.  Investigators are recommended but not mandated to confirm diagnosed 
RAO with ultrasound if available. 
 
Test methodology:  
All Pleth-ox testing will be done by qualified personnel with results classified according to 
Barbeau test pattern classifications (for preprocedure assessment) or simplified classification 
(Normal, Diminished, or Absent waveform) (postprocedure assessments). 
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. 
Following placement of the TRB system, reverse Pleth-Ox exams will be performed at the 
following time points with results recorded in the CRFs as the radial artery antegrade waveform 
being “normal”, “diminished”, or “absent”.   
• 
Within 5 minutes after initial TRB placement 
• 
In the SS (StatSeal Advanced) group only, within 5 minutes after the first partial deflation 
(20 minutes after initial placement). 
• 
At 60 minutes, following first full deflation attempt 
• 
Within 5 minutes after successful full deflation of the TRB  
• 
Within 30’ of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. 
 
 
TR Band left in place (optional): 
 
Following hemostasis, the completed deflated TR band may be left in place on the wrist for a 
period of time (<30 minutes) determined by local practice.  This serves to remind the patient not 
to bend at the wrist and provides for the ability to rapidly reinflate the TR band should bleeding 
be detected.  The TR band should be completed deflated in all cases.  The duration the TR 
band is left in place should not be allowed to vary according to randomization assignment – 
each site investigator is asked to prespecify their protocol and apply the same time of deflated 
TR band to both groups. 
 
 
 [rest of page intentionally blank] 
 

STUDY OVERVIEW GRAPHIC 
 
Cath

 
V. 
STUDY DEFINITIONS AND OUTCOMES 
 
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 >50, 
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. 
Puncture attempts: Number of forward advances of the needle (not puncture sites) needed to 
achieve access 
Procedure Start Time: Time when lidocaine is administered, prior to first puncture attempt. 
Procedure End Time: Time when sheath is removed. 
 
Primary Efficacy Outcome: 
 
▪ 
Total Time to Hemostasis (TTH), defined as the total time the TR Band applies 
compressive force until successful hemostasis is achieved without complication.  This is 
also described as the time of TR band inflation. 
  
Secondary Efficacy Outcome: 
▪ 
Time to discharge, defined as the time from the procedure completion to discharge of 
the patient 
 
Primary Safety Outcome: 
▪ 
Hematoma formation (EASY Classification I-V, ranging from <5cm [I], 5-10cm [II] , 
>10cm to forearm [III], above elbow [IV] and causing ischemia [V]).   
 
Secondary Safety outcomes: 
• 
Radial artery occlusion, as detected by reverse Barbeau/Pleth-ox testing 

VI. 
STUDY STATISTICAL PLAN: 
This is a physician initiated, prospective, randomized, two-arm study, to be conducted at 
experienced ‘Radial First’ centers with the principal investigator having a (minimum) ten case 
experience using StatSeal Advanced.  The primary analysis will be by intention-to-treat 
methodology.   
The sample size of 100 patients is sufficient to have >95% power to detect an average expected 
difference of 20 minutes in time (60 min vs 80 min) to deflation of the TR band between the SS 
and TRB groups, using a two-sided alpha of 0.05, based on the results of the prior pilot study.  
The sample size is sufficient to have >95% power to detect an average expected difference of 
20 minutes in time to discharge (170 min vs 190 min) between the SS and TRB groups, using a 
two-sided alpha of 0.05, based on the results of the prior pilot study adjusted for changes in 
protocol. 
For safety outcomes, the sample size of 100 patients is estimated to have >95% power for 
noninferiority in radial artery occlusion rates, if the rates are consistent with what was seen in 
our prior pilot study (0% control vs 2% Statseal) at an absolute noninferiority margin of 0.5% 
and a two-sided alpha of 0.05.  The study size will have >80% power for noninferiority in 
hematoma rates if the rates are consistent with what was seen in our prior pilot study (10% 
control vs 13% Statseal) at an absolute noninferiority margin of 3% 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. 
Planned subgroup analyses will include analysis of the outcomes according to the following 
procedural characteristics: 
1) Diagnostic vs PCI 
2) Dose of heparin (<5000 units, >5000 units) 
 
Multivariate analysis for hematoma formation and RAO are planned including but not limited to 
the factors of compression time, SS use, sheath size, heparin dose, closing ACT. An interim 
analysis will be performed when half of planned enrollment has been completed to review for 
futility or efficacy. 
 
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.  Those complications not 
related to vascular access will be stored locally only. 
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 devices, 
and forwarded to the Data Center for entry in to the database. 
 
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 anonymized (coded) fashion 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).  SS devices may be used outside of the study depending on local practice and 
availability. 
 
Enrollment in other studies 
Simultaneous or dual enrollment in other investigative or observational protocols that do not 
involve vascular access, anticoagulation, or antiplatelet agents is expressly permitted.  The 
interventions in this trial are not expected to significantly impact upon the outcomes of other 
protocols, however, the site investigator is responsible for ensuring that there is no conflict with 
dual enrollment from the standpoint of the other trial.   
 
Study Activities 

The Investigator is required to perform the study in accordance with the protocol and to use 
devices per their 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 
• 
Adhere to all of the required elements of the Clinical Protocol  
• 
Resolve queries in a timely manner  
• 
Participate in Investigator meetings and emails, 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 hemostatic device 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 SS group may enjoy less discomfort from the shorter length of time that 
the TRB is in place, presuming that the SS does reduce TRB compression time.   Patient in the 

TRB group may experience more attention to the arteriotomy wound and distal perfusion 
compared with those having been treated with a traditional protocol prior to the study.   
Both groups having a planned first deflation time (60 minutes) that is earlier than the traditional 
90-120 minute compression time of the TRB may be at an increased risk of hematoma 
formation. However, this risk should be minimized by the close attention to the vascular access 
site by the recovery room team. In addition, there is no standard deflation time specified in the 
TRB instructions for use, and prior studies have not detected a signal of harm with a 60 minute 
deflation time. 
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 hemostatic device 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. 
REFERENCES: 
1. 
Roffi M, Patrono C, Collet; ESC Scientific Document Group . 2015 ESC Guidelines for 
the management of acute coronary syndromes in patients presenting without persistent 
ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in 
Patients Presenting without Persistent ST-Segment Elevation of the European Society of 
Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. 
 
2. 
Cooper CJ, El-Shiekh RA, Cohen DJ, Blaesing L, Burket MW, Basu A, Moore JA. Effect 
of transradial access on quality of life and cost of cardiac catheterization: A randomized 
comparison. Am Heart J. 1999;138:430-436 
 
3. 
Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for 
coronary angiography or intervention and the impact on major bleeding and ischemic 
events: a systematic review and meta-analysis of randomized trials. Am Heart J. 
509;157:132-140 
 

4. 
Safley DM, Amin AP, House JA, Baklanov D, Mills R, Giersiefen H, Bremer A, Marso 
SP. Comparison of costs between transradial and transfemoral percutaneous coronary 
intervention: a cohort analysis from the Premier research database. Am Heart J. 
2013;165:303-309 e302 
 
5. 
Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV, Kim LK, Wong SC, 
Minutello RM, Messenger JC, Moussa I, Garratt KN, Piana RN, Hillegass WB, Cohen 
MG, Gilchrist IC, Rao SV. Adoption of radial access and comparison of outcomes to 
femoral access in percutaneous coronary intervention: an updated report from the 
national cardiovascular data registry (507-2012). Circulation. 2013;127:2295-2306 
 
6. 
Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-Cabau J, Larose E, Costerousse O, 
Hamon M, Mann T. Transradial approach for coronary angiography and interventions: 
results of the first international transradial practice survey. JACC Cardiovasc Interv. 
2010;3:1022-1031 
 
7. 
Pancholy SB, Patel TM. Effect of duration of hemostatic compression on radial artery 
occlusion after transradial access. Catheter Cardiovasc Interv. 2012;79:78-81 
 
8. 
Rao SV. Observations from a transradial registry: our remedies oft in ourselves do lie. 
JACC Cardiovasc Interv. 2012;5:44-46 
 
 
9. 
Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the 
ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with 
the Allen's test in 1010 patients. Am Heart J. 504;147:489-493 
 
10. 
Wang DS, Chu LF, Olson SE, Miller FJ, Valji K, Wong WH, Rose SC, Austin M, Kuo MD.  
Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in 
Percutaneous Arterial, Venous, and Arteriovenous Dialysis Procedures, Access 
Procedures. Journal of Vascular and Interventional Radiology. January 508; 19: 72-79. 
 
11. 
Seto AH, Rollefson W, Patel MP, et al. Radial haemostasis is facilitated with a potassium 
ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT) 
EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. 
 
 

APPENDICES: 
Appendix 1: 
Sample Informed Consent 
Appendix 2: 
CRF’s