RadiationEXTRA-RADNCT03259126
EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures
A study testing SCUT in people with Radiation and X-rays; Effects, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
Trial summary
Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation, X-rays; Effects, Coronary Disease
- What is being tested?
- SCUT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteItaly
- Study dates
- 7 Aug 2017to 13 Aug 2018
- 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
- all patient undergoing percutaneous coronary procedures through transradial access
Who cannot join
- Interventions performed through a different vascular access
- Procedures performed in patients with ST elevation acute myocardial infarction
- Haemodynamic instability
- Lack of written informed consent
- Age < 18 years old
- Previous coronary artery by-pass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Device Placed Under the Angiographic Table to Reduce Operator Radiation Exposure During Percutaneous Coronary Procedures Through Transradial Approach
Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. We prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. The aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level
Read the detailed description
Interventional cardiologists are routinely exposed to x-rays during their activity increasing the risk of deterministic and stochastic effects. Consequently all the operators should be aware of the possible risks and they should apply all efforts to reduce the radiation dose according to the "As Low As Reasonably Achievable" (ALARA) principle. Moreover interventional cardiologists have to utilise adequate protection devices (lead apron, protective thyroid collar, lead glasses).
Operator performing transradial access procedures showed a significantly higher radiation exposure compared to those performing transfemoral interventions. So, transradial operators should use adjunctive protective shields (as leaded pelvic drapes placed on the patient abdomen) in order to reduce their radio-exposition.
During transradial access a particularly high radiation exposure is observed at operator pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is only partially effective to control this exposition.
Aim of our study was to evaluate the effect of a protective extension of the leaded curtain placed under the angiographic table in term of operator radiation exposure at pelvic level
- Conditions
- Radiation, X-rays; Effects, Coronary Disease
- Being tested
- SCUT
- Keywords
- Transradial, Coronary, X-ray, Radiation, Curtain
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCUTDevice
Two different home made curtains were attached to the angiographic table
| Study group | Role | What they receive |
|---|---|---|
| SCUT | Experimental | Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table Receives: Device: SCUT |
| Control | No intervention | Control Group without the SCUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator pelvic dose
Operator radiation dose at pelvic level
Measured: 24 hours
Secondary outcomes (3)
Operator thorax dose
Operator radiation dose at thorax level
Measured: 24 hours
Operator head dose
Operator radiation dose at head level
Measured: 24 hours
Operator pelvic dose and experimental curtain utilized
Operator radiation Dose at pelvic level comparing the two different experimental leaded curtain utilized
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start7 Aug 2017
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of operator radiation dose at pelvic level during percutaneous coronary procedures through transradial access with or without an extension of the leaded curtain under table
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Sandro Pertini, Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
- Investigators
- Alessandro Sciahbasi, MD, PhD, Principal investigator, Ospeadale Sandro Pertini ASL RM2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259126
- Sponsor's protocol ID
- Pertini05
- Acronym
- EXTRA-RAD
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sciahbasi A, Sarandrea A, Rigattieri S, Patrizi R, Cera M, Di Russo C, Zezza L, Fedele S, Ferraiuolo G. Extended Protective Shield Under Table to Reduce Operator Radiation Dose in Percutaneous Coronary Procedures. Circ Cardiovasc Interv. 2019 Feb;12(2):e007586. doi: 10.1161/CIRCINTERVENTIONS.118.007586.
PubMed 30732471
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Device Placed Under the Angiographic Table to Reduce Operator Radiation Exposure During Percutaneous Coronary Procedures Through Transradial Approach
- ClinicalTrials.gov ID
- NCT03259126
- Acronym / sponsor ID
- EXTRA-RAD / Pertini05
- Conditions
- Radiation, X-rays; Effects, Coronary Disease
- Keywords
- Transradial, Coronary, X-ray, Radiation, Curtain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Ospedale Sandro Pertini, RomaUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 23 Aug 2017 (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.
Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. We prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. The aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level
Detailed description
Interventional cardiologists are routinely exposed to x-rays during their activity increasing the risk of deterministic and stochastic effects. Consequently all the operators should be aware of the possible risks and they should apply all efforts to reduce the radiation dose according to the "As Low As Reasonably Achievable" (ALARA) principle. Moreover interventional cardiologists have to utilise adequate protection devices (lead apron, protective thyroid collar, lead glasses).
Operator performing transradial access procedures showed a significantly higher radiation exposure compared to those performing transfemoral interventions. So, transradial operators should use adjunctive protective shields (as leaded pelvic drapes placed on the patient abdomen) in order to reduce their radio-exposition.
During transradial access a particularly high radiation exposure is observed at operator pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is only partially effective to control this exposition.
Aim of our study was to evaluate the effect of a protective extension of the leaded curtain placed under the angiographic table in term of operator radiation exposure at pelvic level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of operator radiation dose at pelvic level during percutaneous coronary procedures through transradial access with or without an extension of the leaded curtain under table
| Arm | Type | Receives |
|---|---|---|
| SCUT | Experimental | Device: SCUTUse of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table |
| Control | No intervention | –Control Group without the SCUT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patient undergoing percutaneous coronary procedures through transradial access
Key exclusion criteria (6 listed)
- Interventions performed through a different vascular access
- Procedures performed in patients with ST elevation acute myocardial infarction
- Haemodynamic instability
- Lack of written informed consent
- Age < 18 years old
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 |
|---|---|---|
| SCUTTwo different home made curtains were attached to the angiographic table | Device | SCUT |
Primary outcome
Operator pelvic dose
Time frame: 24 hours
Operator radiation dose at pelvic level
3 secondary outcomes
Operator thorax dose
Time frame: 24 hours
Operator head dose
Time frame: 24 hours
Operator pelvic dose and experimental curtain utilized
Time frame: 24 hours
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 20 Aug 2018.
- Derived from this study: PubMed 30732471Sciahbasi A, Sarandrea A, Rigattieri S, Patrizi R, Cera M, Di Russo C, Zezza L, Fedele S, Ferraiuolo G. Extended Protective Shield Under Table to Reduce Operator Radiation Dose in Percutaneous Coronary Procedures. Circ Cardiovasc Interv. 2019 Feb;12(2):e007586. doi: 10.1161/CIRCINTERVENTIONS.118.007586.
- Individual participant dataSharing planned: No
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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.
Alessandro Sciahbasi, MD, PhD principal investigator
Ospeadale Sandro Pertini ASL RM2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCUT in people with Radiation and X-rays; Effects, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
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 1 inclusion and 6 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Operator pelvic dose (time frame: 24 hours). 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 NCT03259126, which also lists 1 linked publication.
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 20 Aug 2018.