Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04285944
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site: 500
• Patients Per Site Per Month: 62.6

Study Details

Study Description

Brief Summary

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®.

Condition or Disease	Intervention/Treatment	Phase
Radiation Exposure	Other: Mavig X-ray Protective Drapes	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: May 31, 2020
• Anticipated Study Completion Date: May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study	Other: Mavig X-ray Protective Drapes; Mavig X-ray Protective Drapes®
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Operator radiation dose [Immediate]

   Gray

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.

2. The coronary angiogram/cardiac catheterization/PCI procedure is elective.

3. 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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiovascular Disease, University Hospitals Leuven	Leuven		Belgium	3000
2	UZ Leuven	Leuven		Belgium

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Keir Mccutcheon, Universitaire Ziekenhuizen Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof Dr Walter Desmet, Professor, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT04285944
• Other Study ID Numbers: S62469
• First Posted: Feb 26, 2020
• Last Update Posted: Mar 4, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 4, 2020