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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
766
Academic Medical Center
Amsterdam, Netherlands
Primary operator radiation exposure (mSv)
Time frame: immediately post-procedure
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