Reduction of Catheterization Radiation Exposure Pad

Phase 3

Completed

• Conditions: Coronary Interventions; Radiation; Exposure Occupational
• Interventions: Device: (sham) radiation absorbing drape (RADPAD®)

• 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

Arm && Interventions

Group	Intervention	Description
Radiation absorbing drape	(sham) radiation absorbing drape (RADPAD®)	Conventional protection measurements. Additionally, a lead-free protective, disposable drape containing bismuth and antimony (RADPAD®) is placed onto the sterile drape on the patient between the operator and the image intensifier.
Dummy group	(sham) radiation absorbing drape (RADPAD®)	Conventional protection measurements. Additionally, a dummy, silicone, disposable drape (appearing identical to the experimental arm) is placed onto the sterile drape on the patient between the operator and the image intensifier.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands