Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention
Phase: NA
Conditions: Coronary Angiography, Coronary Angioplasty
Sponsor: Baylor Research Institute

 
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July 17, 2020; version 1.2 
 
 
STUDY TITLE: 
DISTAL VS PROXIMAL RADIAL ARTERY STUDY (THE DIPRA STUDY) 
“Distal vs. Proximal Radial Artery Access for cardiac catheterization and intervention” 
NCT04318990 
Protocol IRB #: 019-504  
 
PROTOCOL HISTORY 
 
 
Date: 
 
October 24, 2022; version 1.3 
 
 
 
Principal Investigator: 
 
Karim Al-Azizi, MD 
 
 
Sub-Investigator(s):                                      
 
 
Srini Potluri, MD 
Chadi Dib, MD 
Molly Szerlip, MD 
Sameh Sayfo, MD 
Amr Idris, MD 
Jared Christensen, MD 
 
 
Statistician: 
 
Johanna van Zyl, PhD 
 
 
Data Management and Analyst: 
 Jasjit Kaur Banwait, Ph.D. 
 
 
 
 
 
 
 
 
 

PI: Dr. Al-Azizi 
IRB#  
019-504 
 
 
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October 24, 2022; version 1.3 
 
PROTOCOL SIGNATURE PAGE 
Study Title:   
DIstal vs Proximal Radial Artery Study (The DIPRA Study) 
“Distal vs. Proximal Radial Artery Access for cardiac catheterization and intervention” 
 
Protocol Number:  N/A 
 
IRB Number: 019-504 
 
I have read this protocol and agree to adhere to the requirements outlined within. I will provide 
copies of this protocol and all pertinent information to the study personnel under my supervision. 
I will review and discuss this material with them and ensure they are fully informed regarding 
the requirements of this protocol. I will also ensure that this study is conducted in compliance 
with this protocol, Good Clinical Practice (GCP), and all applicable regulatory agencies and their 
requirements. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Investigator (Printed Name) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Investigator (Signature)  
 
 
 
 
 
 
 
 
Date 
 
 
 
 

PI: Dr. Al-Azizi 
IRB#  
019-504 
 
 
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STUDY TEAM CONTACT INFORMATION 
 
Name 
Contact Information 
Role on Study 
Karim Al-Azizi, MD 
Karim.AlAzizi@BSWHealth.org  
Principal Investigator 
Johanna van Zyl, PhD 
Johanna.VanZyl@BSWHealth.org  
Statistician 
Jasjit Kaur Banwait, Ph.D. 
 
 jasjitkaur.banwait@BSWHealth.org 
 
Data 
Management/Analyst 
 
 
 
 

PI: Dr. Al-Azizi 
IRB#  
019-504 
 
 
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Table of Contents 
1 
TABLE OF CONTENTS ............................................................................................................... 4 
2 
LIST OF ABBREVIATIONS ......................................................................................................... 5 
3 
SYNOPSIS .................................................................................................................................... 6 
4 
INTRODUCTION ........................................................................................................................... 8 
4.1 
BACKGROUND .................................................................................................................................. 8 
5 
STUDY OBJECTIVES .................................................................................................................. 8 
6 
STUDY DESIGN ........................................................................................................................... 8 
7 
ASSESSMENT OF HAND FUNCTION ........................................................................................ 8 
8 
STUDY POPULATION ................................................................................................................. 9 
8.1 
ELIGIBILITY CRITERIA ...................................................................................................................... 9 
8.1.1 
Inclusion Criteria ...............................................................................................................................9 
8.1.2 
Exclusion Criteria ............................................................................................................................10 
9 
STUDY VISITS AND ACTIVITIES .............................................................................................. 10 
9.1 
SCREENING AND BASELINE ............................................................................................................. 10 
9.2 
ENROLLMENT ................................................................................................................................. 11 
9.3 
DISTAL RADIAL ACCESS PROCEDURE ............................................................................................ 11 
9.4 
FOLLOW-UP .................................................................................................................................... 12 
9.5 
WITHDRAWAL FROM STUDY ........................................................................................................... 12 
10 
COMPENSATION ....................................................................................................................... 12 
11 
COSTS ........................................................................................................................................ 12 
12 
RISK AND BENEFIT TO PARTICIPANTS ................................................................................ 12 
12.1 
POTENTIAL BENEFITS ...................................................................................................................... 12 
12.2 
POTENTIAL RISKS ............................................................................................................................ 13 
12.2.1 
Physical Risks ..................................................................................................................................13 
12.2.2 
Psychosocial and Privacy Risks .......................................................................................................13 
12.2.3 
Adverse Event Reporting .................................................................................................................13 
13 
RISK/BENEFIT ASSESSMENT ................................................................................................. 14 
14 
STATISTICAL METHODS .......................................................................................................... 14 
15 
PROCEDURES AND INSTRUCTIONS ...................................................................................... 15 
15.1 
PROTOCOL AMENDMENTS ............................................................................................................... 15 
15.2 
RECORDING OF DATA, DOCUMENTATION, AND RETENTION OF DOCUMENTS ................................. 15 
15.3 
PUBLICATION OF RESULTS .............................................................................................................. 15 
15.4 
DISCLOSURE AND CONFIDENTIALITY .............................................................................................. 16  
16 
ETHICS AND GOOD CLINICAL PRACTICE ............................................................................. 16 
16.1 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE ............................................... 16 
16.2 
INFORMED CONSENT ....................................................................................................................... 16 
17 
REFERENCES ............................................................................................................................ 16 
 
 

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IRB#  
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ABBREVIATIONS 
Abbreviation 
Term 
AE 
 
Adverse event 
 
CABG 
Coronary artery bypass grafting 
CBC 
Complete blood count 
DASH 
Disabilities of the Arm, Shoulder, and Hand Questionnaire 
dRA 
Distal radial artery  
e-CRF 
Electronic case report form 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Council for Harmonisation 
IRB 
Institutional Review Board 
PCI 
Percutaneous coronary intervention 
PHI 
Protected health information 
PI 
Principal Investigator 
pRA 
Proximal radial artery  
SAE 
Serious adverse event 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PI: Dr. Al-Azizi 
IRB#  
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SYNOPSIS 
Summary/Rationale:  
This single-center, prospective, randomized study will 
evaluate distal radial artery (dRA) vs. proximal radial artery 
access (pRA) in regards to hand function and radial artery 
occlusion. 
Study Objectives: 
Primary objective is to evaluate hand function following distal 
radial artery access compared to proximal artery access in 
patients undergoing cardiac catheterization. 
Hand function will be assessed by: 
• QuickDASH questionnaire 
• Hand grip test 
• Thumb forefinger pinch test utilizing a pinch gauge 
Secondary objectives: 
Vascular access success rates, hematoma, bleeding, 
complications of vascular access and radial artery occlusion. 
Study Design: 
Single-center, prospective, randomized, study 
Study Intervention(s): 
Distal and proximal radial artery access 
Number of Subjects:  
300 
Inclusion Criteria: 
A patient will be eligible for inclusion in this study if he or 
she meets all of the following criteria:  
1. Age ≥ 18 years. 
2. The distal and proximal radial artery must be palpable 
and non-occlusive flow must be confirmed by 
(Doppler) ultrasound.  
3. Patient should be able to comply with the protocol. 
4. Provide written informed consent before study 
participation.  

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Exclusion Criteria: 
A patient will be ineligible for inclusion in this study if he or 
she meets any of the following criteria:  
1. Obligatory femoral or proximal radial access  
2. On therapeutic oral anticoagulation. 
3. Previous ipsilateral forearm radial artery occlusion. 
4. Very large hand/wrist anatomy that will preclude using 
the available hemostatic radial bands. 
5. Enrollment in another study that competes or interferes 
with this study. 
6. Poor clinical condition like cardiogenic shock, which 
prohibits pre- and post-procedural function tests. 
7. Subject with planned complex PCI or procedure 
necessitating multiple intervention. 
8. Any other condition or co-morbidity which, in the 
opinion of the investigator or operator, may pose a 
significant hazard to the subject if he or she is enrolled 
in the study.  
9. History of stroke with residual deficit that affects hand 
function 
10. Previous radial artery catheterization within 1 year. 
Sponsor: 
Baylor Scott and White Research Institute 
Principal Investigator: 
Karim Al-Azizi, MD 
Primary Study 
Site/Data Center: 
The Heart Hospital Baylor Plano  
1100 Allied Drive | 5th Floor Research Dept. 
Plano, Texas 75093 
Duration of Study: 
2 years 
 
 
 
 
 
 
 
 

PI: Dr. Al-Azizi 
IRB#  
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4.  
INTRODUCTION 
4.1 
Background 
Radial artery catheterization has established itself as a superior arterial access over femoral arterial 
access for cardiac and interventional vascular procedures given its safety and faster recovery for 
patients, Distal radial artery access has been of growing interest for cardiac catheterization as an 
alternative to conventional proximal radial artery access and femoral access especially in patients 
with prior CABG. Multiple reports, case series as well as small sized studies reported feasibility 
of the distal radial artery access in the anatomical snuff box of the hand. Distal radial artery access 
has theoretical advantages including utilizing the left arm to better assess CABG patients while 
maintaining good patient and operator ergonomics as well as eliminating the increased risk with 
femoral access. However, the distal radial artery is a smaller artery and runs in the hand close to 
the radial nerve, which raises the concern of hand function. Radial artery access has been known 
to have a very small risk of radial artery occlusion. The rate of radial artery occlusion in the distal 
radial artery is unknown. There are no studies comparing distal radial artery access to proximal 
radial artery access. 
5.   
STUDY OBJECTIVES 
The primary objective of this study is to evaluate hand function following distal radial artery 
access compared to proximal artery access in patients undergoing cardiac catheterization.  
Hand function will be assessed by: 
• QuickDASH questionnaire 
• Hand grip test 
• Thumb forefinger pinch test utilizing a pinch gauge 
Secondary endpoints include success rates, hematoma, bleeding, rates of radial artery occlusion 
and complications of vascular access.  
6.   
STUDY DESIGN 
This is a prospective, randomized, single-center clinical trial.   
This study will assess the outcomes of hand function utilizing the QuickDASH questionnaire, 
hand strength using the hand grip test, and the thumb and forefinger pinch using an electronic 
pinch gauge. Rates of radial artery occlusion in patients undergoing cardiac catheterization using 
dRA compared to pRA will be analyzed using ultrasound doppler at 1 month and 1 year.  
Approximately 300 patients undergoing coronary angiography or angioplasty at The Heart 
Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac 
catheterization.  
7.  
ASSESSMENT OF HAND FUNCTION 
Hand function will be assessed by the following: 
1. QuickDASH questionnaire  
The DASH outcome measurement is used around the world by clinicians and researchers as a 
tool for self-reported outcome concerning upper-limb musculoskeletal disorders  (Hudak P). It 
consists of two components: symptom questions of 30 items with scores from 1 to 5, and 
optional high performance (sport/music or work) section of 4 items also with scores of 1 to 5. 

PI: Dr. Al-Azizi 
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The optional modules which concern sport, music or work are not used as those are mainly 
utilized to identify the specific limitations by professional athletes and performing artists or other 
group of workers.  
This study will be using the abbreviated, QuickDASH questionnaire.  The purpose of the 
QuickDASH is to use 11 items to measure physical function and symptoms. It decreases 
responder and data entry burden while maintaining a high degree of correlation to the original 
length DASH. 
2. Pinch grip by use of a pinch grip dynamometer. Baseline® Mechanical Pinch Gauge 
(Baseline Medical, Quakertown, PA, USA) will be used to measure pinch force between thumb 
and forefinger. This device is CE certified and is commonly used by physiotherapists. It is 
utilized to evaluate tendon or nerve injury and neuromuscular disorders. Pinch strength will be 
recorded in kilograms. 
3. Hand Grip Test (using a Jamar Hand Hydraulic dynamometer) 
 
l8.  
 
STUDY POPULATION 
The study population will consist of adult male and female patients undergoing cardiac 
catheterization at The Heart Hospital Baylor Plano. 
8.1 
Eligibility Criteria 
8.1.1 Inclusion Criteria 
A patient will be eligible for inclusion in this study if he or she meets all of the following 
criteria:  
1.  Age ≥ 18 years. 
2) The distal and proximal radial artery must be palpable and non-occlusive flow must be 
confirmed by (Doppler) ultrasound.  
3) Patient should be able to comply with the protocol. 
4) Provide written informed consent before study participation. 
8.1.2  Exclusion Criteria  
A patient will be ineligible for inclusion in this study if he or she meets any of the following 
criteria:  
1) Obligatory femoral or forearm radial access  
2) Previous ipsilateral forearm radial artery occlusion. 
3) Patient on therapeutic oral anticoagulation. 
4) Very large hand/wrist anatomy that will preclude using the available hemostatic radial 
bands. 
5) Enrolment in another study that competes or interferes with this study. 

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IRB#  
019-504 
 
 
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6) Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural 
function tests. 
7) Subject with planned complex PCI or procedure necessitating multiple intervention. 
8) Any other condition or co-morbidity which, in the opinion of the investigator or operator, 
may pose a significant hazard to the subject if he or she is enrolled in the study.  
9) History of stroke with residual deficit that affects hand function. 
10) Previous radial artery catheterization within 1 year. 
 
9.   
STUDY VISITS AND ACTIVITIES 
9.1 
Screening and Baseline 
Subjects must meet the inclusion criteria and have none of the exclusion criteria in order to be 
eligible for participation in this study. 
Screening assessments will be collected through review of medical records and by interview 
after informed consent is signed. These screening evaluations may include: 
• Complete Medical History (including history of myocardial infarction, diabetes mellitus, 
hypertension, hypercholesterolemia, previous CABG and PCI) 
• Demographics  
• Vital Signs (Including height and weight) 
• Physical Exam 
• Labs 
o Complete Blood Count (CBC) including platelet count 
o Basic metabolic panel 
o INR, PTT if available, not mandated 
Women of child-bearing potential will also receive a pregnancy test.  
If measurement of any of the above assessments does not occur in the normal course of patient 
care, clinical practice should not be changed to accommodate collection of additional data.    
 
A mandatory screening assessment for research purposes will include, assessing the patency of 
the proximal and distal radial artery with Doppler ultrasound.   
Pre-Procedure Baseline evaluations will include: 
1. Assessment of hand function (bilaterally) 
o Completion of the QuickDASH questionnaire 
o Assessment of the hand grip strength using the hand dynamometer. 
o Assessment of pinch grip by use of a pinch grip dynamometer. Baseline® 
Mechanical Pinch Gauge 
9.2 
Enrollment 

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The lead statistician will use a random number generator to produce a randomization scheme that 
will be used by the study coordinator(s) to allocate study participants to distal or proximal access 
study arms after informed consent is obtained, all inclusion/exclusion is assessed, and the 
participant is found to be eligible for the study. 
Participants randomized to proximal access will receive conventional access procedure according 
to standard of care.  
9.3  Distal Radial Access Procedure 
Participants randomized to distal radial access will have the procedure as follows (Kiemeneij). 
Patients will receive appropriate peri-procedural antiplatelet and anticoagulation medications 
according to standard hospital practice. 
 
The left or the right upper arm is placed comfortably on a cushion on the ipsilateral side of the 
patient. The hand is placed in a mid-supination position. For right distal radial access, the right 
wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. The 
patient is asked to bring the thumb under the other four fingers. This brings the artery more to the 
surface which allows easier puncture.  After disinfection, the patient is covered with a sterile 
drape. A brachial drape is applied to the hand exposing the anatomical snuff box and the 
proximal radial.  
 
Under ultrasound guidance, local anesthesia is applied by subcutaneous injection of 5cc of 
lidocaine filling the radial fossa.  The puncture will be performed at the point of maximal 
pulsation proximal in the anatomical snuffbox. If this fails, a puncture more distal, just outside 
the snuffbox can be attempted. The puncture is preferably done with the traditional radial needle. 
After successful anterior wall puncture a radial sheath wire is advanced. Proper position is 
verified by fluoroscopy or by ultrasound to ensure the wire didn’t traverse the palmar arch. This 
is followed by introduction of a hydrophilic sheath. The size of the sheath used will be 
documented (5 or 6 french radial sheaths). In order to prevent damage to the tip of the introducer 
and sheath, which might damage the artery, a small skin incision can be made followed by 
introducing the sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of 
nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the 
patient’s knees. The choice of wire is at discretion of the operator. In case of left sided access, 
usually the wire encounters some resistance at the flexed left elbow. Careful manipulation of the 
wire direction with the tip of the catheter will usually solve the problem. If necessary a 
hydrophilic wire under fluoroscopy, can be used with special attention not entering small side 
branches in order to prevent perforation. 
 
Hemostasis is performed using a radial hemostatic band, but with the least possible pressure and 
the shortest possible time (patent hemostasis). Technique, device used, and time will be recorded 
in the electronic case report form (e-CRF).  Following the procedure, the patient is free to use 
both arms. No special supportive slings or other mobility limitation measures are required.   
 
9.4 
 Follow-up 
Subject management post-procedure will proceed via standard institutional protocol. Subjects 
will have a follow-up visit one month and 12 months post-procedure (± 10 days).  

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Follow-up visit assessments at 1 month and 12 months will include: 
1. Any clinical change, reinterventions using the radial artery between the index procedure 
and follow up, is to be recorded. 
2. Assess patency of the proximal and distal radial artery with Doppler ultrasound. 
3. Assessment of hand function  
o Completion of the QuickDASH questionnaire 
o Assessment of the hand grip, using the hand dynamometer. 
o Assessment of pinch grip by use of a pinch grip dynamometer. Baseline® 
Mechanical Pinch Gauge 
 
9.5   
Withdrawal from Study 
Subjects may voluntarily discontinue participation in the study at any time, for any reason. The 
Investigator also has the right to discontinue subjects from the study if he/she feels it is in the 
best interest of the subject. 
 
10. 
 
COMPENSATION 
Participants will not receive any compensation for participating in this study. 
 
11. 
 
COSTS 
Participants will not incur any additional research-related costs due to study participation. 
Subject or their insurance company will be required to pay for all expenses related to regular care 
including procedure and other hospital care.  
 
12. 
 
RISK AND BENEFITS TO PARTICIPANTS 
12.1.  
Potential Benefits 
There is no guarantee of direct benefit to the subjects who participate in this study. There is a 
possibility that dRA will reduce the risk of bleeding and radial artery occlusion as well as 
improve patient comfort. Future patients may benefit from the knowledge gained. 
 
12.2.  
Potential Risks 
12.2.1 
Physical Risks 
Possible risks include loss of sensory function in part of the hand if the cutaneous nerve running 
in the anatomical snuffbox becomes damaged, distal embolization can result in digital ischemia 
and occlusion of the branch supplying the scaphoid bone can result in bone necrosis.  
A study with 656 patients reported an incidence of distal radial artery occlusion of 1.5%, 
haematoma of wrist and forearm  (0,8%), edema  (0.2%), numbness (0.6%), dissection (0.3%), 
arteriovenous fistula (0.2%), transient ischemic attack  (0.2%), stroke (0.2%), aneurysm (0.2%), 
death (0.5%) (Kaledin AL, 2014;27). 

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IRB#  
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A skilled and experienced operator minimizes such complications. Operators with adequate 
experience in distal radial access at the discretion of the Principal Investigator are eligible to 
participate.  
 
12.2.2 
Psychosocial & Privacy Risks 
Any time information is collected there is a potential for loss of confidentiality. Every effort will 
be made to keep participant’s information confidential, however this cannot be guaranteed. 
Participation in research study may make participants feel uncomfortable. Participants will be 
informed that they may refuse to participate or stop their participation at any time without effect 
on future medical treatment or relationship with the treating physician. 
 
12.2.3 
Adverse Event Reporting 
An Adverse Event (AE) is any untoward sign, symptom or medical condition occurring at any 
time after the subject receives his/her procedure, even if the event is not considered to be related 
to the study. Abnormal laboratory values or test results constitute AEs only if they induce 
clinical signs or symptoms, are considered clinically significant, or require therapy. 
The adverse  events that will be monitored and reported from the start of the study procedure 
until 1 year after the index procedure are complications related to the procedure which include: 
• Bleeding 
• Hematoma 
• Radial Occlusion 
 
A Serious Adverse Event (SAE) is an undesirable sign, symptom or medical condition which: 
• is fatal  
• is life threatening 
• requires or prolongs hospitalization 
• results in persistent or significant disability/incapacity  
• constitutes a congenital anomaly or a birth defect 
• is medically significant, in that it may jeopardize the subject and may require medical or 
surgical intervention to prevent 1 of the outcomes listed above 
• Hospitalizations not necessarily considered to be SAEs are hospitalizations for:  
• treatment, which was elective or preplanned, for a pre-existing condition that is unrelated 
to the indication under study and did not worsen 
• treatment on an emergency, outpatient basis for an event not fulfilling any of the 
definitions of serious given above and not resulting in hospital admission  
All SAEs will be followed up until resolution or permanent outcome of the event.   
 
13. 
RISK/BENFIT ASSESSMENT 

PI: Dr. Al-Azizi 
IRB#  
019-504 
 
 
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Local hematoma formation or prolonged compression may cause sensory damage or ischemia 
after radial access interventions. Distal radial access allows the arm to stay in a more natural and 
comfortable position for the patient and may reduce the risk of bleeding and artery occlusion. 
Advancing the understanding of distal radial access procedures will contribute to potentially 
easier and safer peri-procedural management of patients undergoing cardiac catheterization. 
 
14.   
STATISTICAL METHODS 
14. Statistical Methods 
Patient demographics and characteristics will be reported and compared between the radial distal 
access (rDA) and proximal distal access (pDA) cohorts. Continuous variables will be reported as 
means ± standard deviations or medians [quartile 1, quartile 3], if skewed. Categorical variables 
will be reported as frequencies and percentages. Differences between demographic and clinical 
variables, as well as safety and compliance, will be assessed via two sample t-tests and Chi-
square tests (or Wilcoxon’s Rank Sum test and Fisher’s Exact test), as appropriate. 
 
14.1 Analysis of Primary Composite Outcome 
The primary composite outcome of hand function will be defined utilizing the average Z-score 
approach (O’Brien, 1984; Sun, 2012). The average z-score for each subject is calculated as the 
average of the z-scores of the differences between pre- and 1-month post-operation 
measurements for three individual tests. The three tests that measure everyday functionality and 
strength of a subject’s hand included in the composite outcome are: (a) the QuickDASH 
questionnaire score (0-100) calculated as [(sum of n responses / n) – 1] * 25, (b) Thumb and 
forefinger pinch strength test (kg), and (c) hand grip strength test (kg). The average of the three 
z-scores are then compared between rDA and pDA using the Wilcoxon rank-sum test. 
 
14.2 Analysis of Secondary Outcomes 
The composite outcome of hand function will be compared at 12-months post-operation using 
the average z-score approach outlined in the primary outcome analysis. The success rate, 
hematoma, bleeding, and radial artery occlusion will be compared between rDA and pDA 
cohorts using a Chi-square test (or Fisher’s exact test). The rate of complications (including 
occurrence of hematoma, bleeding, radial artery occlusion, and complications of vascular access) 
per subject will be compared between the study cohorts using a Poisson Exact test. 
 
14.3 Exploratory Objectives 
Associations with radial artery occlusion will be explored using a logistic regression model and 
adjusted for significant confounders and study cohort if the event rate for occlusion allows for a 
multivariable model. 
 
14.4 Sample Size 

PI: Dr. Al-Azizi 
IRB#  
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A Monte Carlo simulation study was utilized to study the sample size necessary to achieve at 
least 80% power to detect a small clinical difference between dRA and pRA in the primary 
composite outcome of hand function. A small clinical effect is defined as a 10% ± 10% change 
in pre- to post-operation scores in at least one of the three tests for one of the study cohorts. 
Results from the Monte Carlo study indicate that a sample size of n=125 per group is sufficient 
to achieve at least 80% power under a correlation of 0.3 between the three tests. Allowing for a 
loss-to-follow-up rate of 15%, the total number of patients that should be enrolled for the entire 
study is at least 296 (148 per arm). 
 
14.5 Loss to Follow-up 
Subjects lost to follow-up will be excluded from the analyses. Demographics and baseline 
characteristics will be compared between included and lost-to-follow-up subjects. 
 
15. 
 
PROCEDURES AND INSTRUCTIONS 
15.1   Protocol Amendments  
Any substantive changes will be made as formal amendments to the protocol and will be 
submitted for appropriate review by the institutional review board (IRB). 
Amendments affecting the safety of subjects, the scope of the investigation, or the scientific 
quality of the study require additional approval by the IRB. Examples of amendments requiring 
such approval are: 
1. A significant change in the study design (e.g., addition or deletion of a control group) 
2. An increase in the number of invasive procedures to which subjects are exposed 
3. Addition or deletion of a test procedure for safety monitoring 
These requirements for approval should in no way prevent any immediate action from being 
taken by the Investigator to ensure the safety of all subjects included in the study. 
 
15.2   
Recording of Data, Documentation, and Retention of Documents 
Data will be stored and evaluated in such a way as to guarantee subject confidentiality in 
accordance with the legal stipulations applying to confidentiality of data. All study records must 
be available for inspection by the Sponsor (BSWRI), its authorized representatives, the FDA and 
other regulatory authorities. 
Data on subjects collected on CRFs during the study will be documented in an anonymous 
fashion and the subject will only be identified by the study number and by initials if also 
required.  
The Investigator must maintain source documents for each subject in the study including a copy 
of the signed ICF.  
 
15.3   
Publication of Results  

PI: Dr. Al-Azizi 
IRB#  
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An integrated clinical and statistical report will be prepared at the completion of the treatment 
period. However, it is intended that the results of the study will be included on 
http://clinicaltrials.gov and published and/or presented at scientific meetings.  
 
15.4   
Disclosure and Confidentiality 
The Investigator must assure that subjects’ anonymity will be maintained and that their identities 
are protected from unauthorized parties. The Investigator will keep a subject enrollment log 
relating codes to the names of subjects. The Investigator should maintain documents not for 
submission to the Sponsor (Baylor Scott & White Research Institute), e.g., subjects’ signed 
consent forms, in strict confidence. 
 
16.   
ETHICS AND GOOD CLINICAL PRACTICE 
16.1  Institutional Review Board/Independent Ethics Committee 
Before implementing this study, the protocol, the proposed informed consent form and other 
information to subjects will be reviewed by the BSWRI IRB. The Investigators will not begin 
any study subject activities until approval from the IRB has been documented and provided as a 
letter to the Investigator. Before implementation, the Investigators will submit to and receive 
documented approval from the IRB of any modifications made to the protocol or any 
accompanying material to be provided to the subject after initial IRB approval, with the 
exception of those necessary to reduce immediate risk to study subjects. 
16.2  Informed Consent 
Each subject will be informed that participation in the study is voluntary, that he/she may 
withdraw from the study at any time, and that withdrawal of consent will not affect his/her 
subsequent medical treatment or relationship with the treating physician. 
This informed consent should be given by means of a standard written statement, written in 
nontechnical language. The subject should read and consider the statement before signing and 
dating it, and should be given a copy of the signed document. No subject can enter the study 
before his/her informed consent has been obtained. 
 
 
17.   REFERENCES 
 
Hudak P, A. P. (n.d.). Development of an Upper Extremity Outcome Measure: The DASH 
(Disabilities of the Arm, Shoulder, and Hand). American Journal of Industrial Medicine 
1996; 29:602-608.  
Kaledin AL, K. I. (2014;27). Pecularities of arterial access in endovascular surgery in elderly 
patients. Adv Gerontol, 115-9. 

PI: Dr. Al-Azizi 
IRB#  
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Kiemeneij, F. (n.d.). Left distal transradial access in the anatomical snuffbox for coronary 
angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 
20;13(7):851-857. EuroIntervention, 851-587. 
O’Brien, P. (1984). Procedures for comparing samples with multiple endpoints. Biometrics, 40, 
1079–1087. 
Sun, H. (2012). Evaluating Treatment efficacy by multiple end points in phase II acute heart 
failure clinical trials. Circulation: Heart Failure., 5 (6), 742-749.