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OpenTrials
Completed

NCT Number: NCT03139968

Reduction of Catheterization Radiation Exposure Pad

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.

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Key information

Conditions

Radiation; Exposure Occupational Coronary Interventions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All CAGs and PCI's

Exclusion criteria

  • Other interventional procedures

Treatment and study plan

(sham) radiation absorbing drape (RADPAD®)

Device

Primary outcomes

  1. Primary operator radiation exposure (mSv)

    Time frame: immediately post-procedure

Sponsors and collaborators

Lead sponsor

J.P.S Henriques

Other

Registry information

Official study title

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

Acronym: RECAP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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