ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial
Phase: NA
Conditions: Radiation Exposure
Sponsor: NYU Langone Health

 
 
Official Title: 
ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) 
Trial  
NCT Number: 
NCT06233578 
Study Number: 
s23-01408 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
January 3, 2024 
 
 

 
 
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Interventional Template Version: 19 July 2023 
 
 
 
 
 
 
 
Tool Revision History: 
 
Version Number 
Version Date 
Summary of Revisions Made 
1.0 
3 JAN 2024 
Original version 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Interventional Template Version: 19 July 2023 
 
 
 
 
ATTENUATE TRIAL 
(rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) 
 
Principal Investigator: 
 
Giorgio A. Medranda, MD 
Department of Medicine 
259 First Street Mineola, NY 11501 
Giorgio.Medranda@nyulangone.org 
516 877-2626 
NYULMC Study Number: 
s23-01408  
Study Product: 
Protective scatter-radiation absorbing shield, RADPAD 
protection drape. 
Study Product Provider: 
[If applicable] 
NYU Langone Hospital - Long Island 
ClinicalTrials.gov 
Number                 
Pending. 
 
Initial version: 3 January 2024 
Amended: 
  
 

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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations (CFR) on the Protection 
of Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with Food and Drug 
Administration (FDA) and DHHS regulations. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
 

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Table of Contents 
 
STATEMENT OF COMPLIANCE ................................................................................................................ III 
LIST OF ABBREVIATIONS ........................................................................................................................ VII 
PROTOCOL SUMMARY .............................................................................................................................. 9 
SCHEMATIC OF STUDY DESIGN ............................................................................................................. 11 
1 
KEY ROLES ....................................................................................................................................... 12 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ..................... 12 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE .............................................................. 12 
2.2 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE ............................................................ 12 
2.2.1 
Preclinical Data........................................................................ Error! Bookmark not defined. 
2.2.2 
Clinical Data to Date ................................................................ Error! Bookmark not defined. 
2.3 
RATIONALE .................................................................................................................................. 13 
2.4 
POTENTIAL RISKS & BENEFITS ...................................................................................................... 13 
2.4.1 
Known Potential Risks ........................................................................................................... 13 
2.4.2 
Known Potential Benefits ...................................................................................................... 13 
3 
OBJECTIVES AND PURPOSE ......................................................................................................... 14 
3.1 
PRIMARY OBJECTIVE .................................................................................................................... 14 
3.2 
SECONDARY OBJECTIVES (IF APPLICABLE) .................................... ERROR! BOOKMARK NOT DEFINED. 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................. 14 
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................. 14 
4.2 
STUDY ENDPOINTS....................................................................................................................... 14 
4.2.1 
Primary Study Endpoints ....................................................................................................... 14 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................. 14 
5.1 
INCLUSION CRITERIA .................................................................................................................... 14 
5.2 
EXCLUSION CRITERIA ................................................................................................................... 15 
5.3 
VULNERABLE SUBJECTS ............................................................................................................... 15 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 15 
5.4.1 
Use of DataCore/Epic Information for Recruitment Purposes Error! Bookmark not defined. 
5.5 
DURATION OF STUDY PARTICIPATION ............................................................................................ 16 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 16 
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION ................................................................................ 16 
5.7.1 
Reasons for Withdrawal or Termination ................................................................................ 16 
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................. 16 
5.8 
PREMATURE TERMINATION OR SUSPENSION OF STUDY .................................................................. 16 
6 
STUDY DEVICE AND/OR PROCEDURAL INTERVENTION  .......................................................... 17 
6.1 
STUDY DEVICE AND CONTROL DESCRIPTION ................................................................................. 17 
6.1.1 
Acquisition ............................................................................................................................. 17 
6.1.2 
Device Specific Considerations ............................................................................................. 17 
6.2 
STUDY PROCEDURAL INTERVENTION(S) DESCRIPTION ................... ERROR! BOOKMARK NOT DEFINED. 
6.2.1 
Administration of Procedural Intervention ............................... Error! Bookmark not defined. 
6.2.2 
Procedures for Training of Clinicians on Procedural InterventionError! 
Bookmark 
not 
defined. 
6.2.3 
Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention
 
Error! Bookmark not defined. 
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 18 
7.1 
STUDY PROCEDURES/EVALUATIONS ............................................................................................. 18 
7.1.1 
Study Specific Procedures .................................................................................................... 18 

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7.1.2 
Standard of Care Study Procedures ..................................................................................... 18 
7.2 
STUDY SCHEDULE ........................................................................................................................ 18 
7.2.1 
Screening .............................................................................................................................. 18 
7.2.2 
Enrollment/Baseline ................................................................ Error! Bookmark not defined. 
7.2.3 
Intermediate Visits ................................................................... Error! Bookmark not defined. 
7.2.4 
Final Study Visit ....................................................................... Error! Bookmark not defined. 
7.2.5 
Withdrawal/Early Termination Visit.......................................... Error! Bookmark not defined. 
7.2.6 
Unscheduled Visit .................................................................... Error! Bookmark not defined. 
7.3 
PARTICIPANT ACCESS TO STUDY DEVICE AT STUDY CLOSURE ....... ERROR! BOOKMARK NOT DEFINED. 
8 
ASSESSMENT OF SAFETY ............................................................................................................. 18 
8.1 
SPECIFICATION OF SAFETY PARAMETERS ...................................... ERROR! BOOKMARK NOT DEFINED. 
8.1.1 
Definition of Adverse Events (AE) ........................................... Error! Bookmark not defined. 
8.1.2 
Definition of Serious Adverse Events (SAE) ........................... Error! Bookmark not defined. 
8.1.3 
Definition of Unanticipated Problems (UP) .............................. Error! Bookmark not defined. 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT ....................................... ERROR! BOOKMARK NOT DEFINED. 
8.2.1 
Severity of Event ..................................................................... Error! Bookmark not defined. 
8.2.2 
Relationship to Study Device .................................................. Error! Bookmark not defined. 
8.2.3 
Expectedness .......................................................................... Error! Bookmark not defined. 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UPERROR! BOOKMARK NOT 
DEFINED. 
8.4 
REPORTING PROCEDURES – NOTIFYING THE IRB .......................................................................... 19 
8.4.1 
Adverse Event Reporting ........................................................ Error! Bookmark not defined. 
8.4.2 
Serious Adverse Event Reporting ........................................... Error! Bookmark not defined. 
8.4.3 
Unanticipated Problem Reporting ........................................... Error! Bookmark not defined. 
8.4.4 
Reporting of Pregnancy ........................................................... Error! Bookmark not defined. 
8.5 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR ...... ERROR! BOOKMARK NOT DEFINED. 
8.6 
REPORTING PROCEDURES – NOTIFYING THE FDA ......................... ERROR! BOOKMARK NOT DEFINED. 
8.7 
REPORTING PROCEDURES – PARTICIPATING INVESTIGATORS ......... ERROR! BOOKMARK NOT DEFINED. 
8.8 
STUDY HALTING RULES ................................................................ ERROR! BOOKMARK NOT DEFINED. 
8.9 
SAFETY OVERSIGHT ..................................................................................................................... 19 
9 
CLINICAL MONITORING .................................................................................................................. 19 
10 
STATISTICAL CONSIDERATIONS .................................................................................................. 19 
10.1 
STATISTICAL AND ANALYTICAL PLANS (SAP) ................................................................................. 19 
10.2 
STATISTICAL HYPOTHESES ........................................................................................................... 19 
10.3 
ANALYSIS DATASETS .................................................................................................................... 19 
10.4 
DESCRIPTION OF STATISTICAL METHODS ...................................................................................... 19 
10.4.1 General Approach ................................................................................................................. 19 
10.4.2 Analysis of the Primary Efficacy Endpoint(s) ........................................................................ 20 
10.4.3 Analysis of the Secondary Endpoint(s) ................................... Error! Bookmark not defined. 
10.4.4 Safety Analyses ....................................................................... Error! Bookmark not defined. 
10.4.5 Adherence and Retention Analyses ........................................ Error! Bookmark not defined. 
10.4.6 Baseline Descriptive Statistics ................................................ Error! Bookmark not defined. 
10.4.7 Planned Interim Analysis ......................................................... Error! Bookmark not defined. 
10.5 
SAMPLE SIZE ............................................................................................................................... 20 
10.6 
MEASURES TO MINIMIZE BIAS ....................................................................................................... 20 
10.6.1 Enrollment/Randomization/Masking Procedures .................................................................. 20 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 20 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ....................................................................... 20 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 21 
13.1 
ETHICAL STANDARD ..................................................................................................................... 21 
13.2 
INSTITUTIONAL REVIEW BOARD ..................................................................................................... 21 
13.3 
INFORMED CONSENT PROCESS .................................................................................................... 21 

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13.3.1 Consent and Other Informational Documents Provided to Participants ................................ 21 
13.3.2 Consent Procedures and Documentation ............................................................................. 21 
13.4 
POSTING OF CLINICAL TRIAL CONSENT FORM ................................ ERROR! BOOKMARK NOT DEFINED. 
13.5 
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................... 22 
13.6 
SECONDARY FUTURE USE OF STORED DATA ................................................................................. 23 
14 
DATA HANDLING AND RECORD KEEPING ................................................................................... 23 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 23 
14.2 
STUDY RECORDS RETENTION ....................................................................................................... 23 
14.3 
PROTOCOL DEVIATIONS ............................................................................................................... 23 
14.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 24 
15 
STUDY FINANCES ............................................................................................................................ 24 
15.1 
FUNDING SOURCE ........................................................................................................................ 24 
15.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 24 
15.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 24 
16 
STUDY ADMINISTRATION .................................................... ERROR! BOOKMARK NOT DEFINED. 
16.1 
STUDY LEADERSHIP ..................................................................... ERROR! BOOKMARK NOT DEFINED. 
17 
CONFLICT OF INTEREST POLICY .................................................................................................. 25 
18 
REFERENCES ................................................................................................................................... 26 
19 
ATTACHMENTS ................................................................................................................................ 27 
20 
SCHEDULE OF EVENTS ....................................................... ERROR! BOOKMARK NOT DEFINED. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Be sure to update the table of contents when you are finished creating your protocol. You can do this in 
Microsoft Word by going to the References tab and clicking on “Update Table” in the Table of Contents 
section.  
 

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List of Abbreviations 
 
AE 
Adverse event/adverse experience 
ALARA 
As low as reasonably achievable 
CCL 
Cardiac catheterization laboratory 
CFR 
Code of federal regulations 
CRF 
Case report form 
CSOC 
Clinical study oversight committee 
DAP 
Dose area product 
DCC 
Data coordinating center 
DHHS 
Department of health and human services 
DSA 
Digital subtraction angiography 
DSMB 
Data and safety monitoring board 
eCRF 
Electronic clinical report form 
FFR 
Federal financial report 
FT 
Fluoroscopy time 
FWA 
Federalwide assurance 
GCP 
Good clinical practice 
HIPAA 
Health insurance portability and accountability act 
ICF 
Informed consent form 
ICH 
International conference on harmonisation 
IEC 
Independent ethics committee 
IRB 
Institutional review board 
ISM 
Independent safety monitor 
ITT 
Intention to treat 
MOP 
Manual of procedures 
N 
Number (typically refers to participants) 
NIH 
National institutes of health 
OE 
Operator exposure 
OHRP 
Office for human research protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal investigator 
QA 
Quality assurance 
QC 
Quality control 
SAE 
Serious adverse event/serious adverse experience 

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SOP 
Standard operating procedure 
TD 
Total dose 
US 
United States 
 
 

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Protocol Summary 
Title 
ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) 
Trial   
Short Title 
ATTENUATE Trial 
Brief Summary 
Despite improvements in radiation safety, interventional cardiologists are 
increasingly exposed to radiation during cardiac catheterization procedures. 
The RADPAD protection drape was designed as a protective scatter-radiation 
absorbing shield with the goal of reducing scatter radiation. It is a sterile, lead 
free, light weight, and disposable radiation protection shield that is placed 
directly over the sterile patient drapes. The RADPAD is comprised of antimony 
and bismuth providing protection during low-energy fluoroscopy and high-
energy cine and digital subtraction angiography (DSA) settings.  
 
Early and smaller studies have demonstrated a ~20% relative reduction in 
scatter radiation, with the majority of scatter reduction for the main operator, 
followed by other personnel and the patient(1-4).  
 
The purpose of the ATTENUATE (rAdpad proTecTion drapE iN redUcing 
rAdiaTion Exposure) Trial is to examine the impact of the RADPAD in a 
contemporary cardiac catheterization laboratory (CCL), during diagnostic, 
coronary and structural cardiac catheterization procedures, in a large 
prospective, randomized controlled trial. 
Objectives 
Elucidate the degree of reduction in relative exposure to the proximal operator 
using the RADPAD in a contemporary CCL practice. 
Methodology 
Prospective, Randomized Controlled Trial 
Endpoint 
Operator exposure (OE)/dose area product (DAP) (uSv/mGy*cm2) of the 
proximal operator between procedures in which guideline directed radiation 
protocols and the RADPAD was utilized vs. those in which only guideline 
directed radiation protocols were utilized. 
Study Duration 
Up to 5 years. 
Participant Duration 
1 Day. 
Duration of IP 
administration 
N/A 
Population 
Proximal operator of cardiac catheterization procedures and patient cases 
(patients undergoing the cardiac catheterization procedures) 

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Study Sites 
NYU Langone Hospital - Long Island 
Number of participants 
Up to 1,000 patient-cases and up to 100 proximal operator-subjects expected 
to be enrolled across 1 site. The proximal operator cohort is expected to 
include a few interventional cardiologist attending physicians, interventional 
cardiology fellows, cardiovascular disease fellows and physician assistants 
performing multiple cases each, which in total would amount to 1,000 cases 
performed by 100 proximal operators. 
Description of Study 
Agent/Procedure 
The RADPAD protection drape was designed as a protective scatter-radiation 
absorbing shield with the goal of reducing scatter radiation. It is a sterile, lead 
free, light weight, and disposable radiation protection shield that is placed 
directly over the sterile patient drapes. The RADPAD is comprised of antimony 
and bismuth providing protection during low-energy fluoroscopy and high-
energy cine and DSA settings. 
Reference Therapy 
N/A 
Key Procedures 
Cardiac catheterization radiation data acquisition. 
Statistical Analysis 
The study will be analyzed using comparative statistics.  
 
 
 

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Schematic of Study Design 
 
 
 
 

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1 Key Roles 
 
Principal investigator 
 
Giorgio A. Medranda, MD 
Clinical Assistant Professor 
Department of Medicine at NYU Long Island School of Medicine 
516 877-2626 
giorgio.medranda@nyulangone.org 
 
NYU Langone Hospital – Long Island 
259 First Street  
Mineola, NY 11501 
 
2 Introduction, Background Information and Scientific Rationale 
 
2.1 Background Information and Relevant Literature 
 
As the field of interventional cardiology continues to expand, highlighted by the meteoric rise of transcatheter structural interventions, ionizing 
radiation exposure and its associated risk is expected to increase. Ultimately, the goal must be to acquire the clinical information necessary while 
keeping radiation doses as low as reasonably achievable (ALARA). As a result, there is renewed interest in establishing a culture of radiation 
safety in many CCLs across the country(5). 
 
Developing evidence-based strategies aimed at lowering radiation exposure to patients, CCL staff, and physicians, fueled by advances in the field 
of radiation safety, is of paramount importance to promote longevity and accomplish this endeavor. Among these measures are several which 
have been proven and implemented as standard of care(6-16). Novel adjunct techniques and equipment continue to emerge and have garnered 
attention over the last decade such as the RADPAD.  
 
2.2 Name and Description of the Investigational Device  
 
The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is a 
sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is 
comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and DSA settings. Early and smaller 

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studies of the RADPAD have demonstrated a ~20% relative reduction in scatter radiation, with the majority of scatter reduction for the main 
operator, followed by other personnel and the patient(1-4). The RADPAD is FDA-approved and is used in accordance with its indications. 
 
2.3 Rationale 
 
The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is 
a sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is 
comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and DSA settings. Early and 
smaller studies have demonstrated a ~20% relative reduction in scatter radiation, with the majority of scatter reduction for the main operator, 
followed by other personnel and the patient(1-4). Universal adoption and uptake of the RADPAD in radiation safety guidelines and protocols has 
not occurred. Furthermore, the impact of the RADPAD protection drape in a contemporary CCL remains unclear. Thus, the purpose of the 
ATTENUATE Trial is to examine the impact of the RADPAD in a contemporary CCL, during diagnostic, coronary and structural cardiac 
catheterization cases, in a large prospective, randomized controlled trial. 
 
2.4 Potential Risks & Benefits 
2.4.1 Known Potential Risks 
 
This study involves no more than minimal risk to the proximal operator subjects and patient-cases of the procedure. All proximal operators of each 
cardiac catheterization procedure enrolled (subjects), will practice radiation safety according to the standard of care utilizing guideline directed 
radiation protocols as dictated by the local Department of Medical Physics/Radiation Safety regardless of the arm in which they are randomized to. 
There are no known risks related to the use of the RADPAD. The risk of not using the RADPAD is no different than standard of care. 
 
The patients undergoing the cardiac catheterization procedure by the proximal operators (subjects) will do so with no alterations in the quality or 
method of care delivered to them. 
2.4.2 Known Potential Benefits 
 
While there are no anticipated direct benefits to individual subjects, the potential benefits of the proposed study and aggregation of data far 
outweigh the potential for any breaches in confidentiality as discussed above. In addition, investigators are not proposing to perform any additional 
procedures or adjustments to procedures that would not be allowable under other circumstances. 
 
We believe that this study will contribute to the knowledge of radiation safety in this contemporary era of interventional cardiology. The results of 
this study may be useful to regulatory agencies like the FDA, investigators, the device industry, physicians and CCL staff, and may help guide 
future clinical guidelines for radiations safety in the CCL. 
 

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3 Objectives and Purpose 
3.1 Primary Objective 
 
Elucidate the degree of reduction in relative exposure to the proximal operator using the RADPAD in a contemporary CCL practice.   
4 Study Design and Endpoints 
4.1 Description of Study Design 
 
This is a prospective, randomized controlled trial that will enroll proximal operators performing cardiac catheterization procedures and randomize 
them prior to the procedure using computer-based simple randomization to use of the standard guideline directed radiation protocols with 
RADPAD vs. standard guideline directed radiation protocols alone. 
4.2 Study Endpoints 
4.2.1 Primary Study Endpoints 
 
The primary study endpoint is OE/DAP (uSv/mGy*cm2) of the proximal operator between procedures in which guideline directed radiation 
protocols and the RADPAD was utilized vs. those in which only guideline directed radiation protocols were utilized. This endpoint measures the 
operator’s radiation exposure while accounting for the amount of radiation used during any given cardiac catheterization procedure, which is 
known to vary depending on the duration of the case and the patient characteristics. This is the most common primary endpoint utilized in similar 
smaller and older studies. 
5 Study Enrollment and Withdrawal 
5.1 Inclusion Criteria (Employees) 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
 
a) Proximal operator of a cardiac catheterization procedure as defined by the individual performing the procedure closest to the source of 
radiation. This may be either physician assistants of the CCL, fellows of cardiovascular disease, interventional cardiology fellows or 
attending interventional cardiologists at NYU Langone Hospital - Long Island. 
b) Age ≥18 years  
c) Willing and able to consent. 
 

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5.2 Exclusion Criteria (Employees) 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
a) Anyone unable or unwilling to give informed consent. 
 
b) Anyone pregnant or breastfeeding. 
 
c) A proximal operator performing a cardiac catheterization procedure where there are not located on the right-side of the patient and/or 
behind the radiation shield. 
 
d) Any proximal operator who wishes to use the RADPAD regardless of being in the study/is unwilling to be randomized  
 
 
Inclusion Criteria: Patient Cases 
In order for a case to be eligible to be included in this study, it must meet all of the following criteria: 
 
a) Cardiac catheterization procedure at NYU Langone Hospital – Long Island. 
b) Age ≥18 years of the patient undergoing cardiac catheterization.  
Exclusion Criteria: Patient Cases 
There are no specific exclusion criteria that pertain exclusively to the cardiac catheterization procedure. 
 
5.3 Vulnerable Subjects 
  
This study examines radiation exposure to employees (proximal operators) during cardiac catheterization procedures thus it is scientifically 
necessary to enroll employees to conduct this study. Radiation is already routinely measured for all who work in the CCL by the Department of 
Medical Physics/Radiation Safety and utilization of the RADPAD protection drape contributes an insignificant amount of time (seconds) to the 
preparation of a cardiac catheterization procedure. The proximal operator-Participants’ decision to participate or to withdraw from the study will not 
impact their employment, salary, and/or performance evaluation as no one in a supervisory role is recruiting for this study. Proximal operators who 
wish to use the RADPAD regardless of participation in the study will be informed that they may choose not to be in the study and elect to use the 
RADPAD per their preference. 
5.4 Strategies for Recruitment and Retention 
 
Recruitment will occur in person by the PI and will be without coercion with verbal consent and a waiver of documentation of consent which 
includes the key information document and biomedical consent form. Recruitment will begin in January of 2024 upon IRB approval. Recruitment 
will begin in aggregate based on the various personnel who may be involved in the relevant procedures. The PI will schedule brief educational 

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sessions to describe the study. Subjects will be reminded that they can withdraw at anytime by contacting PI. Subjects who give verbal consent 
will participate in the study. This will give the personnel sufficient time to understand the study and consent prior to cardiac catheterization 
procedures as to not delay patient care. 
 
Since the only patient level data obtained will be de-identified data points with no need to record PHI in the record, patient-subjects will not be 
approached for recruitment, rather they will be enrolled using a waiver consent and authorization.  
 
The PI is the only person involved in recruitment and informed consent process for the proximal operator subjects. The PI does not have any 
supervisory role over the relevant personnel who may be eligible to participate in the study as proximal operators. 
  
5.5 Duration of Study Participation 
 
Subjects enrolled will participate in this study for the duration of the cardiac catheterization procedure (less than one day).   
  
5.6 Total Number of Participants and Sites  
 
The study will seek to include up to 1,000 cardiac catheterization procedures (cases) being performed by up to 100 proximal operators with an 
expected duration of the study of up to 5 years. 
5.7 Participant Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination 
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator may terminate participation in the study 
if: 
 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further study 
participation 
5.7.2 Handling of Participant Withdrawals or Termination 
 
There is no scheduled follow-up in this study as there are no adverse events are expected from this study (as it is minimal risk). The biggest risk 
that could occur is a breach of confidentiality. Once a participant withdraws their data will be deleted and excluded from this study.  
5.8 Premature Termination or Suspension of Study 
 

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This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the 
reason for study suspension or termination, will be provided by the suspending or terminating party to investigator and regulatory authorities. If the 
study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and satisfy the sponsor, IRB and/or FDA.  
6 Study Device and/or Procedural Intervention  
6.1 Study Device and Control Description 
 
The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is a 
sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is 
comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and DSA settings. This study will 
enroll proximal operators performing cardiac catheterization procedures and randomize them prior to the procedure using computer-based simple 
randomization to use of the standard guideline directed radiation protocols with RADPAD vs. standard guideline directed radiation protocols alone. 
6.1.1 Acquisition 
 
The RADPAD is routinely stocked and available to all interventional cardiologists for use in all CCLs at NYU Langone Hospital – Long Island. 
6.1.2 Device Specific Considerations 
 
There are several models of RADPAD that are FDA-approved and used throughout CCLs in the country. This study will utilize the RADPAD® 
ORANGE Peripheral Shield (11”x 34”) as this is among the most used in other CCLs and the model currently approved and used in procedures at 
NYU Langone Hospital and NYU Langone Hospital – Brooklyn. Examining the utility of other specific models in addition to this one would not be 
expected to offer any additional meaningful insight to the study question.   

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7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
7.1.1 Study Specific Procedures 
 
• 
For those randomized to the RADPAD arm, a single RADPAD® ORANGE Peripheral Shield will be placed on the patient’s drape in a 
sterile fashion according to the manufacturer’s instructions for use prior to commencement of the procedure. 
• 
All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any 
the protective apron worn by the participant, provided by the Department of Medical Physics/Radiation Safety. 
• 
Medical history of the patients undergoing cardiac catheterization will be collected on the day of procedure using the medical record 
without collection of patient-specific identifiers. This information is important to collect to allow interventional cardiologists outside of our 
institution to understand our patient population as certain co-morbidities affect the amount of radiation operators are exposed to. 
• 
Radiation data and date/type of each cardiac catheterization procedure each participant performs will be collected on the day of procedure 
using the medical record without collection of participant-specific identifiers.  
7.1.2 Standard of Care Study Procedures 
 
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol to minimize the risk of ionizing radiation to all 
CCL staff as defined by the Department of Medical Physics/Radiation Safety. This includes, but is not limited to use of the following equipment: 
 
• 
Shielded skirt beneath the procedure table 
• 
Mobile hanging or grounded radiation shields 
• 
Personal protective equipment such as thyroid collars, and aprons (standard or suspended) 
 
7.2 Study Schedule 
 
The only evaluation in this study will be performed on the day of the cardiac catheterization procedure. 
7.2.1 Screening  
 
Screening will occur prior to each cardiac catheterization procedure as described above. 
  
8 Assessment of Safety 
 

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No adverse events are expected from this study, as it is minimal risk, the biggest risk that could occur is a breach of confidentiality. If breach of 
confidentiality occurs, the IRB will be notified immediately.  
8.1 Safety Oversight 
 
The Principal Investigator will be responsible to oversee the safety of the study at his/her site. This safety monitoring will include careful 
assessment and appropriate reporting of adverse events as noted above, as well as the construction and implementation of a site data and safety-
monitoring plan. Adverse events will be reviewed on the quarterly basis. There are no stopping rules. An annual report will be submitted to the IRB 
with the continuing review submission. 
9 Clinical Monitoring 
 
Clinical site monitoring will be conducted to ensure that the rights and well-being of human subjects are protected, that the reported trial data are 
accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, 
and with applicable regulatory requirement(s). 
 
• Monitoring for this study will be performed on-site quarterly by the Principal Investigator with 100% data verification. 
10 Statistical Considerations 
10.1 Statistical and Analytical Plans (SAP) 
 
The study will be analyzed using comparative statistics without use of a formal SAP.    
10.2 Statistical Hypotheses 
 
The objective of the statistical analysis of the data generated is to assess the degree of radiation exposure reduction with use of the RADPAD 
during cardiac catheterization procedures. 
10.3 Analysis Datasets 
 
Two cohorts will be analyzed based on simple randomization using an Intention-to-Treat (ITT) analysis dataset.  
10.4 Description of Statistical Methods 
10.4.1 General Approach 
 

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The study will present categorical and continuous data as percentages and means (with standard deviations), respectively. Inferential tests will be 
considered significant if the p-value is <0.05.  
10.4.2 Analysis of the Primary Efficacy Endpoint(s) 
 
The primary study endpoint is OE/DAP (uSv/mGy*cm2) of the proximal operator between procedures in which guideline directed radiation 
protocols and the RADPAD was utilized vs. those in which only guideline directed radiation protocols were utilized. This endpoint measures the 
operator’s radiation exposure while accounting for the amount of radiation used during any given cardiac catheterization procedure, which is 
known to vary depending on the duration of the case and the patient characteristics. This is the most common primary endpoint utilized in similar 
smaller and older studies. This is a continuous variable which will be analyzed statistically using the student’s t-test. 
10.5 Sample Size 
 
The study expects to enroll up to 100 proximal operators (up to 100 proximal operators performing up to 1,000 cardiac catheterization procedures 
on up to 1,000 patients). This number of operators are expected to perform that number of cardiac catheterization procedures to meet the study’s 
objectives. Sample size in this study is not driven by statistical requirements. 
10.6 Measures to Minimize Bias 
10.6.1 Enrollment/Randomization/Masking Procedures 
 
This study will utilize computer-based simple randomization to RADPAD or no RADPAD without use of a sham product or blinding as all cardiac 
catheterization procedures are expected to produce variable amounts of radiation and the primary outcome adjusts the proximal OE for this 
variation. Thus, both sham products and blinding is considered unnecessary.    
11 Source Documents and Access to Source Data/Documents 
 
Electronic case report forms (eCRF) will be completed for each study subject. It is the Principal Investigator’s responsibility to ensure the accuracy, 
completeness, and timeliness of the data reported in the subject’s eCRF. The Principal Investigator will complete the eCRF forms as soon as 
possible after information is collected. Source documents for the study include the eCRF and patient medical records.  
12 Quality Assurance and Quality Control 
 
Quality control procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be 
generated. Any missing data or data anomalies will be communicated for clarification/resolution. Additionally, quality control of the radiation 
detection device is performed regularly at intervals determined by the Department of Medical Physics/Radiation Safety. 

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13 Ethics/Protection of Human Subjects 
13.1 Ethical Standard 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection of Human Subjects of Research 
codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or the ICH E6. 
13.2 Institutional Review Board 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. 
Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented to the study. All changes to the consent form will be IRB approved; a 
determination will be made regarding whether previously consented participants need to be re-consented. 
 
13.3 Informed Consent Process 
13.3.1 Consent and Other Informational Documents Provided to Participants 
 
Consent forms describing in detail the study device, study procedures, and risks are given to the participant however written documentation of 
informed consent will not be required prior to enrolling. The following consent materials are submitted with this protocol  
• Key Information Form 
• Biomedical Consent Form 
13.3.2 Consent Procedures and Documentation 
 
Recruitment and informed consent will occur in person by the PI and will be without coercion with verbal consent and a waiver of documentation of 
consent which includes the key information document and biomedical consent form script. The PI does not have a supervisory role over any of the 
potentially eligible employee subjects (proximal operators). Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study and continues throughout the individual’s study participation. Extensive discussion of risks and possible benefits of 
participation will be provided to the participants and their families. Consent forms will be IRB-approved and the participant will be asked to read 
and review the document. The investigator will explain the research study to the participant and answer any questions that may arise. All 
participants will receive a verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential risks of the study 
and of their rights as research participants. Participants will have the opportunity to carefully review the consent form and ask questions prior to 
consenting. The participants should have the opportunity to discuss the study with or think about it prior to agreeing to participate. The participants 
may withdraw consent at any time throughout the course of the trial. A copy of the key info sheet and consent script will be given to the 
participants for their records. The principal investigator will keep documentation of all consent processes in the study’s regulatory binder. The 
rights and welfare of the participants will be protected by emphasizing to them that the quality of their medical care will not be adversely affected if 
they decline to participate in this study. 

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Recruitment will begin in January of 2024 upon IRB approval. Recruitment will begin in aggregate based on the various personnel who may be 
involved in the relevant procedures. The PI will schedule brief educational sessions to describe the study. Subjects will be reminded that they can 
withdraw at anytime by contacting PI. Subjects who give verbal consent will participate in the study. This will give the personnel sufficient time to 
understand the study and consent prior to cardiac catheterization procedures as to not delay patient care. 
 
Since the only patient level data obtained will be de-identified data points with no need to record PHI in the record, subjects will not be approached 
for recruitment, rather they will be enrolled using a waiver consent and authorization.  
 
 
Waiver of documentation of consent (employee subjects): 
 
The only record linking a subject to the study is the informed consent form and the principal risk would be potential harm resulting from a breach of 
confidentiality. Additionally, the study presents no more than minimal risk of harm to subjects and involves no procedures for which written consent 
is normally required outside of the research context (RADPAD is utilized outside of this study at each operators discretion and is FDA-approved).  
 
Waiver of Consent and Health Insurance Portability and Accountability Act (HIPAA) (patient subjects): 
 
With regards to the waiver of consent, for the patient data collected, this involved no more than minimal risk to the patients. The research could not 
be practically carried out for 1,000 patients without the requested waiver. This waiver does not adversely affect the rights and welfare of the 
patients undergoing cardiac catheterization procedures. With regards to the waiver of authorization, there will be no collection of protected health 
information of the patients undergoing cardiac catheterization procedures. 
13.4 Participant and Data Confidentiality 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the sponsor(s) and their agents. This 
confidentiality is extended to cover research and clinical information relating to participants. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB or pharmaceutical company supplying study 
product may inspect all documents and records required to be maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at the site for internal use during the study. At the end of the study, all records 
will continue to be kept in a secure location for as long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be stored at NYU Langone Hospital- Long 
Island. This will not include the participant’s contact or identifying information. Rather, individual participants and their research data will be 
identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by NYU 

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Langone Hospital -Long Island research staff will be secured and password protected. At the end of the study, all study databases will be de-
identified and archived at the NYU Langone Hospital – Long Island. 
13.5 Secondary Future Use of Stored Data 
 
Future use of data will not occur outside the scope of this study and its estimated duration. 
14 Data Handling and Record Keeping 
The following subsections should include a description of the data handling and record keeping for the conduct of the trial. 
14.1 Data Collection and Management Responsibilities 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. The investigator is responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data. Black ink is required to ensure 
clarity of reproduced copies. When making changes or corrections, cross out the original entry with a single line, and initial and date the change. 
DO NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for recording data for each participant enrolled 
in the study. Data reported in the eCRF derived from source documents should be consistent with the source documents or the discrepancies 
should be explained and captured in a progress note and maintained in the participant’s official electronic study record. 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical laboratory data will be entered into 
REDCap. The data system includes password protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
14.2 Study Records Retention 
 
Study documents will be retained for the longer of 3 years after close-out, 5 years after final reporting/publication, or 2 years after the last approval 
of a marketing application is approved for the device for the indication for which it is being investigated or 2 years after the investigation is 
discontinued and FDA is notified if no application is to be filed or if the application has not been approved for such indication. No records will be 
destroyed without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
 
14.3 Protocol Deviations 
 

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A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures (MOP) requirements. The noncompliance 
may be either on the part of the participant, the investigator, or the study site staff. As a result of deviations, corrective actions are to be developed 
by the site and implemented promptly. 
 
These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report deviations in accordance with NYULH HRP Policies 
and Procedures. 
 
All protocol deviations must be addressed in study source documents. 
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is responsible for knowing and adhering to their 
IRB requirements. Further details about the handling of protocol deviations will be included in the MOP. 
 
14.4 Publication and Data Sharing Policy 
 
It is anticipated that the results of this study will be presented at scientific meetings and/or published in a peer reviewed scientific or medical 
journals. 
15 Study Finances 
15.1 Funding Source 
 
There are no funding sources for this study. 
15.2 Costs to the Participant 
 
There is no cost to participate in this study.  
15.3 Participant Reimbursements or Payments 
 
There are no participant reimbursements or payments.  

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16 Conflict of Interest Policy 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical industry, is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the trial.  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain greater than the minimum allowable by 
their institution, etc.) must have the conflict reviewed by the NYU Langone Conflict of Interest Management Unit (CIMU) with a Committee-
sanctioned conflict management plan that has been reviewed and approved by the study sponsor prior to participation in this study. All NYULH 
investigators will follow the applicable conflict of interest policies. 
 
 
 

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17 References 
 
1. 
Sharma D, Ramsewak A, Manoharan G, Spence MS. Efficacy of RADPAD(R) protection drape in reducing radiation exposure to the 
primary operator during Transcatheter Aortic Valve Implantation (TAVI). Minerva Cardioangiol. 2016;64(1):41-6. 
2. 
Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, et al. Efficacy of the RADPAD Protection Drape in Reducing 
Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017;10(11). 
3. 
Shah P, Khanna R, Kapoor A, Goel PK. Efficacy of RADPAD protection drape in reducing radiation exposure in the catheterization 
laboratory-First Indian study. Indian Heart J. 2018;70 Suppl 3(Suppl 3):S265-S8. 
4. 
Bhat KG, Guleria VS, Singla M, Bohra V, Kumar JR, Bharadwaj P, et al. Minimizing scattered radiation dose in cardiac catheterization 
laboratory during interventional procedures using lead free drape - MILD study. Indian Heart J. 2022;74(3):201-5. 
5. 
Hirshfeld JW, Jr., Ferrari VA, Bengel FM, Bergersen L, Chambers CE, Einstein AJ, et al. 2018 ACC/HRS/NASCI/SCAI/SCCT Expert 
Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 2: 
Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection: A Report of the American College of 
Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2018;71(24):2829-55. 
6. 
Abdelaal E, Plourde G, MacHaalany J, Arsenault J, Rimac G, Dery JP, et al. Effectiveness of low rate fluoroscopy at reducing operator 
and patient radiation dose during transradial coronary angiography and interventions. JACC Cardiovasc Interv. 2014;7(5):567-74. 
7. 
Agarwal S, Parashar A, Bajaj NS, Khan I, Ahmad I, Heupler FA, Jr., et al. Relationship of beam angulation and radiation exposure in the 
cardiac catheterization laboratory. JACC Cardiovasc Interv. 2014;7(5):558-66. 
8. 
Christopoulos G, Makke L, Christakopoulos G, Kotsia A, Rangan BV, Roesle M, et al. Optimizing Radiation Safety in the Cardiac 
Catheterization Laboratory: A Practical Approach. Catheter Cardiovasc Interv. 2016;87(2):291-301. 
9. 
Duran A, Hian SK, Miller DL, Le Heron J, Padovani R, Vano E. Recommendations for occupational radiation protection in interventional 
cardiology. Catheter Cardiovasc Interv. 2013;82(1):29-42. 
10. 
Fetterly KA, Mathew V, Lennon R, Bell MR, Holmes DR, Jr., Rihal CS. Radiation dose reduction in the invasive cardiovascular laboratory: 
implementing a culture and philosophy of radiation safety. JACC Cardiovasc Interv. 2012;5(8):866-73. 
11. 
Karadag B, Ikitimur B, Durmaz E, Avci BK, Cakmak HA, Cosansu K, et al. Effectiveness of a lead cap in radiation protection of the head in 
the cardiac catheterisation laboratory. EuroIntervention. 2013;9(6):754-6. 
12. 
Kim KP, Miller DL. Minimising radiation exposure to physicians performing fluoroscopically guided cardiac catheterisation procedures: a 
review. Radiat Prot Dosimetry. 2009;133(4):227-33. 
13. 
Marcie S, Gerard JP, Dejean C, Feuillade J, Gautier M, Montagne L, et al. The inverse square law: A basic principle in brachytherapy. 
Cancer Radiother. 2022;26(8):1075-7. 
14. 
Politi L, Biondi-Zoccai G, Nocetti L, Costi T, Monopoli D, Rossi R, et al. Reduction of scatter radiation during transradial percutaneous 
coronary angiography: a randomized trial using a lead-free radiation shield. Catheter Cardiovasc Interv. 2012;79(1):97-102. 
15. 
Salcido-Rios J, McNamara DA, VanOosterhout S, VanLoo L, Redmond M, Parker JL, et al. Suspended lead suit and physician radiation 
doses during coronary angiography. Catheter Cardiovasc Interv. 2022;99(4):981-8. 
16. 
van Rooijen BD, de Haan MW, Das M, Arnoldussen CW, de Graaf R, van Zwam WH, et al. Efficacy of radiation safety glasses in 
interventional radiology. Cardiovasc Intervent Radiol. 2014;37(5):1149-55. 
 
 

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18 Attachments 
 
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are stored and modified separately. As such, 
modifications to these documents do not require protocol amendments. 
 
• Verbal Consent Script 
• Key Information Form 
• Application for Waiver of Authorization and Consent: Patient Subjects 
• Application for Waiver of Documentation of Consent: Employee Subjects