- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285944
Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.
March 2, 2020 updated by: Prof Dr Walter Desmet, Universitaire Ziekenhuizen KU Leuven
Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention.
Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses.
Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation.
Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®.
The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabine Van Roey
- Phone Number: +32468312267 003216342465
- Email: sabine.vanroey@uzleuven.be
Study Contact Backup
- Name: Keir Mccutcheon
- Phone Number: +32468312267 +32468312267
- Email: keir.mccutcheon@uzleuven.be
Study Locations
-
-
-
Leuven, Belgium
- Recruiting
- UZ Leuven
-
Contact:
- Sabine Van Roey
- Phone Number: +32 16 34 24 66
- Email: sabine.vanroey@uzleuven.be
-
Principal Investigator:
- Keir McCutcheon, MD
-
Leuven, Belgium, 3000
- Recruiting
- Department of Cardiovascular Disease, University Hospitals Leuven
-
Contact:
- Sabine Van Roey
- Phone Number: 003216342465
- Email: sabine.vanroey@uzleuven.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
- The coronary angiogram/cardiac catheterization/PCI procedure is elective.
- The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.
Exclusion Criteria:
1. The procedure is an emergency and/or the patient is unstable. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Active Comparator: Study
|
Mavig X-ray Protective Drapes®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operator radiation dose
Time Frame: Immediate
|
Gray
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Keir Mccutcheon, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McCutcheon K, Vanhaverbeke M, Dabin J, Pauwels R, Schoonjans W, Desmet W, Bennett J. Efficacy of MAVIG X-Ray Protective Drapes in Reducing CTO Operator Radiation. J Interv Cardiol. 2021 Dec 14;2021:3146104. doi: 10.1155/2021/3146104. eCollection 2021.
- McCutcheon K, Vanhaverbeke M, Pauwels R, Dabin J, Schoonjans W, Bennett J, Adriaenssens T, Dubois C, Sinnaeve P, Desmet W. Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009627. doi: 10.1161/CIRCINTERVENTIONS.120.009627. Epub 2020 Oct 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Anticipated)
May 31, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
February 24, 2020
First Submitted That Met QC Criteria
February 24, 2020
First Posted (Actual)
February 26, 2020
Study Record Updates
Last Update Posted (Actual)
March 4, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- S62469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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