Reduction of Catheterization Radiation Exposure Pad

Phase 3

Completed

• Conditions: Coronary Interventions; Radiation; Exposure Occupational

• Registration Number: NCT03139968
• Lead Sponsor: J.P.S Henriques

Brief 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).

Study Timeline

• Study Start: 2017-01-16
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2017-06-01
• Study Completion: 2017-10-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 766

Inclusion Criteria

• All CAGs and PCI's

Exclusion Criteria

• Other interventional procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary operator radiation exposure (mSv)	immediately post-procedure

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands