ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

NCT06233578 | Completed Results FDA Device

• 1 other identifier: 23-01408
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the impact of the RADPAD in proximal operators in a contemporary cardiac catheterization laboratory (CCL), during diagnostic, coronary and structural cardiac catheterization procedures, in a large prospective, randomized controlled trial. 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. The primary outcome of interest was relative exposure of the proximal operator between the guideline directed radiation protocols and RADPAD use vs. guideline directed radiation protocols alone.

Conditions

Radiation Exposure

Outcome Measures

Primary Outcomes (2)

• Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator

  This is a continuous variable which will be analyzed statistically using the student's t-test.

  From start of each procedure until end of each procedure (up to 1 day)

• OE/DAP (uSv/mGy*cm2) of the Proximal Operator

  This is a continuous variable which will be analyzed statistically using the student's t-test.

  From start of each procedure until end of each procedure (up to 1 day)

Study Arms (2)

RADPAD

EXPERIMENTAL

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.

Device: RADPAD

No RADPAD

NO INTERVENTION

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.

Interventions

RADPAD 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 Digital subtraction angiography (DSA) settings.

RADPAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥18 years
• Willing and able to consent.
• Cardiac catheterization procedure at NYU Langone Hospital - Long Island.
• Age ≥18 years of the patient undergoing cardiac catheterization.

You may not qualify if:

• Anyone unable or unwilling to give informed consent.
• Anyone pregnant or breastfeeding.
• 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.
• Any proximal operator who wishes to use the RADPAD regardless of being in the study/is unwilling to be randomized

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Hospital - Long Island

New York, New York, 11501, United States

Location

Results Point of Contact

• Title: Giorgio A. Medranda, MD
• Organization: NYU Langone Health

giorgio.medranda@nyulangone.org

(516) 877-2626

Study Officials

• Giorgio A. Medranda, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: January 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to giorgio.medranda@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)