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

U

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

Conditions

Radiation Exposure

Treatments

Other: Mavig X-ray Protective Drapes

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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®.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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. -

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,000 participants in 2 patient groups

Study
Active Comparator group
Treatment:
Other: Mavig X-ray Protective Drapes
Control
No Intervention group

Trial contacts and locations

2

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Central trial contact

Sabine Van Roey; Keir Mccutcheon

Data sourced from clinicaltrials.gov

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