Occupational Radiation Exposure in Interventional CardiologyFREEPADRADNCT06931171
Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
A study testing Patient-Applied Pelvic Lead Shielding in people with Occupational Radiation Exposure in Interventional Cardiology, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
Ionising radiation is a recognised occupational hazard in interventional cardiology. This prospective, randomised trial aims to evaluate the effectiveness of additional radiation protection by existing devices but with a different use, specifically the use of medical lead aprons (designed and used to be worn by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Radiation Exposure in Interventional Cardiology
- What is being tested?
- Patient-Applied Pelvic Lead Shielding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesGreece
- Study dates
- 30 Jan 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing transradial diagnostic coronary angiography or angioplasty.
- Adults aged 18 years and older.
- Informed consent provided.
Who cannot join
- Acute STEMI requiring primary percutaneous coronary intervention (PCI).
- Patients undergoing structural heart interventions.
- Initially femoral access or crossover to femoral access procedures.
- Patients unable to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
First Department of Cardiology, Hippokration General Hospital of Athens
Athens, Attica, 11527
First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens
Athens, Attica, 11527
About this study
Ionising radiation is a recognised occupational hazard in interventional cardiology. This prospective, randomised trial aims to evaluate the effectiveness of additional radiation protection by existing devices but with a different use, specifically the use of medical lead aprons (designed and used to be worn by the medical and nursing staff for radiation protection) covering the patient's lower abdominal and pelvic area during transradial coronary angiography and angioplasty. The intervention's efficacy will be assessed by measuring the reduction in operator radiation exposure and determining the impact of various clinical and procedural factors.
Read the detailed description
Ionizing radiation refers to any type of radiation capable of interacting with matter. It plays a vital role in medical diagnostics and therapeutic applications. Imaging techniques allow for timely and accurate diagnosis, while advanced therapies contribute to longer life expectancy and improved quality of life. However, ionizing radiation carries inherent risks, making its controlled use essential. Radiation exposure is not immediately perceptible but can result in significant damage to the exposed organism. Common effects of high-dose exposure include ocular damage and skin injuries, while radiation is also associated with cellular-level damage, leading to an increased risk of malignancies. Exposure is proportional to time, inversely proportional to the square of the distance from the source, and accumulates over time.
Despite technological advancements and improved X-ray systems, the increasing complexity and frequency of interventional cardiology procedures have led to higher radiation exposure in catheterization laboratories. This poses a major occupational hazard for medical staff, highlighting the need for effective methods to reduce radiation exposure and protect healthcare professionals. Operator radiation exposure varies depending on experience, procedure type, patient characteristics, X-ray system features, and protective measures used. These measures include disposable gloves, shields, lead aprons, and robotic systems.
This prospective, randomised trial evaluates the efficacy of a cost-effective (namely zero-cost) and very easily utilised radiation protection strategy for interventional cardiologists during transradial coronary procedures. By applying a triple-layer lead apron to the patient's pelvic region, the study aims to reduce operator radiation exposure while maintaining standard procedural outcomes. The randomized controlled trial will compare the intervention group utilizing the additional shielding with a control group employing standard radiation protection methods. Key measurements include direct operator radiation exposure and its relation to patient-specific and procedural factors. Findings may establish a practical method for reducing the specific radiation-related occupational hazard related to modern transracial interventional cardiology.
- Being tested
- Patient-Applied Pelvic Lead Shielding
- Keywords
- Occupational Radiation Exposure, Interventional Cardiology, Radiation Protection, Transradial Access, Radiation Safety, Operator Radiation Dose, Radiation Hazard Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Applied Pelvic Lead ShieldingRadiation
The intervention involves the application of a triple-layer lead apron to the patient's lower abdominal and pelvic region during transradial coronary procedures. The apron measures 75 cm × 45 cm and is composed of three layers of 0.25 mm Pb-equivalent material. This protective shield is placed on the patient in addition to standard operator radiation protection measures. The primary goal of this intervention is to reduce scatter radiation exposure to the operator, thereby improving occupational safety in the catheterization laboratory. This approach leverages existing radiation protection materials in a novel configuration.
| Study group | Role | What they receive |
|---|---|---|
| Use of conventional radiation protection measures. | No intervention | This group will undergo transradial coronary procedures using only conventional radiation protection measures. These include standard operator lead aprons, fixed protective drapes, and other standard shielding equipment typically employed in the catheterization laboratory. No additional radiation protection devices or techniques will be applied to the patient. This arm serves as the baseline for comparison with the intervention group. |
| Additional patient-applied pelvic lead shielding | Experimental | This group will undergo transradial coronary procedures with the addition of a patient-applied pelvic lead shield. Alongside the conventional radiation protection measures used in the control group, a triple-layer lead apron will be placed over the patient's lower abdominal and pelvic region. This shield, composed of three 0.25 mm Pb-equivalent layers, is designed to reduce scatter radiation exposure to the operator. The intervention aims to assess the effectiveness of this additional protective measure in reducing operator radiation dose. Receives: Radiation: Patient-Applied Pelvic Lead Shielding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures
Primary Outcomes:
Absolute Operator Radiation Exposure:
Direct measurement of operator exposure (µSv) using a dosimeter placed outside the lead apron at chest level.
Measured: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures
Primary Outcomes:
Relative Operator Radiation Exposure:
Measured as the ratio of operator exposure (µSv) to patient radiation dose area product (cGy·cm²).
Measured: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start30 Jan 2025
- Primary completion30 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Occupational Radiation Exposure in Interventional CardiologyStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Latsios, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931171
- Sponsor's protocol ID
- FREEPADRAD
- Acronym
- FREEPADRAD
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah RM, Patel D, Abbate A, Cowley MJ, Jovin IS. Comparison of transradial coronary procedures via right radial versus left radial artery approach: A meta-analysis. Catheter Cardiovasc Interv. 2016 Dec;88(7):1027-1033. doi: 10.1002/ccd.26519. Epub 2016 Apr 1.
PubMed 27037544Vijayalakshmi K, Kelly D, Chapple CL, Williams D, Wright R, Stewart MJ, Hall JA, Sutton A, Davies A, Haywood J, de Belder MA. Cardiac catheterisation: radiation doses and lifetime risk of malignancy. Heart. 2007 Mar;93(3):370-1. doi: 10.1136/hrt.2006.098731. No abstract available.
PubMed 17322516Gutierrez-Barrios A, Camacho-Galan H, Medina-Camacho F, Canadas-Pruano D, Jimenez-Moreno A, Calle-Perez G, Vazquez-Garcia R. Effective Reduction of Radiation Exposure during Cardiac Catheterization. Tex Heart Inst J. 2019 Jun 1;46(3):167-171. doi: 10.14503/THIJ-17-6548. eCollection 2019 Jun.
PubMed 31708696Sciahbasi A, Piccaluga E, Sarandrea A, Nucci G, Caretto N, Rigattieri S, Fedele S, Romano S, Penco M. Operator Pelvic Radiation Exposure During Percutaneous Coronary Procedures. J Invasive Cardiol. 2018 Feb;30(2):71-74. Epub 2017 Dec 15.
PubMed 29245152Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.
PubMed 32338611Venneri L, Rossi F, Botto N, Andreassi MG, Salcone N, Emad A, Lazzeri M, Gori C, Vano E, Picano E. Cancer risk from professional exposure in staff working in cardiac catheterization laboratory: insights from the National Research Council's Biological Effects of Ionizing Radiation VII Report. Am Heart J. 2009 Jan;157(1):118-24. doi: 10.1016/j.ahj.2008.08.009.
PubMed 19081407
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
- ClinicalTrials.gov ID
- NCT06931171
- Acronym / sponsor ID
- FREEPADRAD / FREEPADRAD
- Keywords
- Occupational Radiation Exposure, Interventional Cardiology, Radiation Protection, Transradial Access, Radiation Safety, Operator Radiation Dose, Radiation Hazard Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ionising radiation is a recognised occupational hazard in interventional cardiology. This prospective, randomised trial aims to evaluate the effectiveness of additional radiation protection by existing devices but with a different use, specifically the use of medical lead aprons (designed and used to be worn by the medical and nursing staff for radiation protection) covering the patient's lower abdominal and pelvic area during transradial coronary angiography and angioplasty. The intervention's efficacy will be assessed by measuring the reduction in operator radiation exposure and determining the impact of various clinical and procedural factors.
Detailed description
Ionizing radiation refers to any type of radiation capable of interacting with matter. It plays a vital role in medical diagnostics and therapeutic applications. Imaging techniques allow for timely and accurate diagnosis, while advanced therapies contribute to longer life expectancy and improved quality of life. However, ionizing radiation carries inherent risks, making its controlled use essential. Radiation exposure is not immediately perceptible but can result in significant damage to the exposed organism. Common effects of high-dose exposure include ocular damage and skin injuries, while radiation is also associated with cellular-level damage, leading to an increased risk of malignancies. Exposure is proportional to time, inversely proportional to the square of the distance from the source, and accumulates over time.
Despite technological advancements and improved X-ray systems, the increasing complexity and frequency of interventional cardiology procedures have led to higher radiation exposure in catheterization laboratories. This poses a major occupational hazard for medical staff, highlighting the need for effective methods to reduce radiation exposure and protect healthcare professionals. Operator radiation exposure varies depending on experience, procedure type, patient characteristics, X-ray system features, and protective measures used. These measures include disposable gloves, shields, lead aprons, and robotic systems.
This prospective, randomised trial evaluates the efficacy of a cost-effective (namely zero-cost) and very easily utilised radiation protection strategy for interventional cardiologists during transradial coronary procedures. By applying a triple-layer lead apron to the patient's pelvic region, the study aims to reduce operator radiation exposure while maintaining standard procedural outcomes. The randomized controlled trial will compare the intervention group utilizing the additional shielding with a control group employing standard radiation protection methods. Key measurements include direct operator radiation exposure and its relation to patient-specific and procedural factors. Findings may establish a practical method for reducing the specific radiation-related occupational hazard related to modern transracial interventional cardiology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of conventional radiation protection measures. | No intervention | –This group will undergo transradial coronary procedures using only conventional radiation protection measures. These include standard operator lead aprons, fixed protective drapes, and other standard shielding equipment typically employed in the catheterization laboratory. No additional radiation protection devices or techniques will be applied to the patient. This arm serves as the baseline for comparison with the intervention group. |
| Additional patient-applied pelvic lead shielding | Experimental | Radiation: Patient-Applied Pelvic Lead ShieldingThis group will undergo transradial coronary procedures with the addition of a patient-applied pelvic lead shield. Alongside the conventional radiation protection measures used in the control group, a triple-layer lead apron will be placed over the patient's lower abdominal and pelvic region. This shield, composed of three 0.25 mm Pb-equivalent layers, is designed to reduce scatter radiation exposure to the operator. The intervention aims to assess the effectiveness of this additional protective measure in reducing operator radiation dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing transradial diagnostic coronary angiography or angioplasty.
- Adults aged 18 years and older.
- Informed consent provided.
Key exclusion criteria (4 listed)
- Acute STEMI requiring primary percutaneous coronary intervention (PCI).
- Patients undergoing structural heart interventions.
- Initially femoral access or crossover to femoral access procedures.
- Patients unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Applied Pelvic Lead ShieldingThe intervention involves the application of a triple-layer lead apron to the patient's lower abdominal and pelvic region during transradial coronary procedures. The apron measures 75 cm × 45 cm and is composed of three layers of 0.25 mm Pb-equivalent material. This protective shield is placed on the patient in addition to standard operator radiation protection measures. The primary goal of this intervention is to reduce scatter radiation exposure to the operator, thereby improving occupational safety in the catheterization laboratory. This approach leverages existing radiation protection materials in a novel configuration. | Radiation | Additional patient-applied pelvic lead shielding |
Primary outcome
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures
Time frame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.
Primary Outcomes: Absolute Operator Radiation Exposure: Direct measurement of operator exposure (µSv) using a dosimeter placed outside the lead apron at chest level.
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures
Time frame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.
Primary Outcomes: Relative Operator Radiation Exposure: Measured as the ratio of operator exposure (µSv) to patient radiation dose area product (cGy·cm²).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Results publication: PubMed 27037544Shah RM, Patel D, Abbate A, Cowley MJ, Jovin IS. Comparison of transradial coronary procedures via right radial versus left radial artery approach: A meta-analysis. Catheter Cardiovasc Interv. 2016 Dec;88(7):1027-1033. doi: 10.1002/ccd.26519. Epub 2016 Apr 1.
- Results publication: PubMed 17322516Vijayalakshmi K, Kelly D, Chapple CL, Williams D, Wright R, Stewart MJ, Hall JA, Sutton A, Davies A, Haywood J, de Belder MA. Cardiac catheterisation: radiation doses and lifetime risk of malignancy. Heart. 2007 Mar;93(3):370-1. doi: 10.1136/hrt.2006.098731. No abstract available.
- Results publication: PubMed 31708696Gutierrez-Barrios A, Camacho-Galan H, Medina-Camacho F, Canadas-Pruano D, Jimenez-Moreno A, Calle-Perez G, Vazquez-Garcia R. Effective Reduction of Radiation Exposure during Cardiac Catheterization. Tex Heart Inst J. 2019 Jun 1;46(3):167-171. doi: 10.14503/THIJ-17-6548. eCollection 2019 Jun.
- Results publication: PubMed 29245152Sciahbasi A, Piccaluga E, Sarandrea A, Nucci G, Caretto N, Rigattieri S, Fedele S, Romano S, Penco M. Operator Pelvic Radiation Exposure During Percutaneous Coronary Procedures. J Invasive Cardiol. 2018 Feb;30(2):71-74. Epub 2017 Dec 15.
- Results publication: PubMed 32338611Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.
- Results publication: PubMed 19081407Venneri L, Rossi F, Botto N, Andreassi MG, Salcone N, Emad A, Lazzeri M, Gori C, Vano E, Picano E. Cancer risk from professional exposure in staff working in cardiac catheterization laboratory: insights from the National Research Council's Biological Effects of Ionizing Radiation VII Report. Am Heart J. 2009 Jan;157(1):118-24. doi: 10.1016/j.ahj.2008.08.009.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Applied Pelvic Lead Shielding in people with Occupational Radiation Exposure in Interventional Cardiology, run by National and Kapodistrian University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures (time frame: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06931171, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.