Trial Outcomes & Findings for ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial (NCT NCT06233578)
NCT ID: NCT06233578
Last Updated: 2026-01-28
Results Overview
This is a continuous variable which will be analyzed statistically using the student's t-test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1000 participants
Primary outcome timeframe
From start of each procedure until end of each procedure (up to 1 day)
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
RADPAD
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. 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.
RADPAD: 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.
|
No RADPAD
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. 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.
|
|---|---|---|
|
Overall Study
STARTED
|
500
|
500
|
|
Overall Study
COMPLETED
|
500
|
500
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial
Baseline characteristics by cohort
| Measure |
RADPAD
n=500 Participants
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. 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.
RADPAD: 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.
|
No RADPAD
n=500 Participants
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. 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.
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 6.4 • n=41 Participants
|
70 years
STANDARD_DEVIATION 6.1 • n=1581 Participants
|
69 years
STANDARD_DEVIATION 6.25 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=41 Participants
|
205 Participants
n=1581 Participants
|
410 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
295 Participants
n=41 Participants
|
295 Participants
n=1581 Participants
|
590 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
500 Participants
n=41 Participants
|
500 Participants
n=1581 Participants
|
1000 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
500 participants
n=41 Participants
|
500 participants
n=1581 Participants
|
1000 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: From start of each procedure until end of each procedure (up to 1 day)This is a continuous variable which will be analyzed statistically using the student's t-test.
Outcome measures
| Measure |
RADPAD
n=500 Participants
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. 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.
RADPAD: 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.
|
No RADPAD
n=500 Participants
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. 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.
|
|---|---|---|
|
Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator
|
6.41 10,000 x uSv / mGy*cm^2
Standard Deviation 15.56
|
3.51 10,000 x uSv / mGy*cm^2
Standard Deviation 5.49
|
PRIMARY outcome
Timeframe: From start of each procedure until end of each procedure (up to 1 day)This is a continuous variable which will be analyzed statistically using the student's t-test.
Outcome measures
| Measure |
RADPAD
n=500 Participants
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. 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.
RADPAD: 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.
|
No RADPAD
n=500 Participants
Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. 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.
|
|---|---|---|
|
OE/DAP (uSv/mGy*cm2) of the Proximal Operator
|
6.41 10,000 x uSv / mGy*cm^2
Standard Deviation 15.56
|
3.51 10,000 x uSv / mGy*cm^2
Standard Deviation 5.49
|
Adverse Events
RADPAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No RADPAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place