NCT03139968

Reduction of Catheterization Radiation Exposure Pad

Reduction of the Operator's Radiation Exposure During CAG and PCI With RADPAD, a Randomized Controlled Double-blinded Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 766 (actual)
• Sponsor: J.P.S Henriques · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The RECAP-trial is a randomized controlled, double blinded, superiority trial studying the efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation received by the operator during diagnostic angiograms and percutaneous coronary interventions.

Detailed description

A total of 750 consecutive diagnostic angiograms and percutaneous coronary interventions were randomly assigned to the radiation-attenuating (RADPAD®), a dummy drape or a control group in a 1:1:1 ratio. The drapes will be used in addition to conventional shielding material. Primary radiation exposure is measured blindly by a dose aware meter (Philips) positioned at a set location on the operator. Radiation exposure is measured by the X-ray systems (DAP in Gy·cm2). The primary outcome is the effective dose received by the first operator (mSv/Gy·cm2).

Conditions

• Radiation; Exposure Occupational
• Coronary Interventions

Interventions

Type	Name	Description
DEVICE	(sham) radiation absorbing drape (RADPAD®)

Timeline

• Start date: 2017-01-16
• Primary completion: 2017-06-01
• Completion: 2017-10-01
• First posted: 2017-05-04
• Last updated: 2023-01-31

Locations

1 site across 1 country: Netherlands