Reduction of Catheterization Radiation Exposure Pad (RECAP)

J.P.S Henriques

Status and phase: Completed; Phase 3

Conditions: Radiation; Exposure Occupational; Coronary Interventions

Treatments: Device: (sham) radiation absorbing drape (RADPAD®)

Study type: Interventional

Funder types: Other

Identifiers

NCT03139968

RECAP-RCT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 766 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All CAGs and PCI's

Exclusion criteria

• Other interventional procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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766 participants in 3 patient groups

Radiation absorbing drape

Experimental group

Description:

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.

Treatment:

Device: (sham) radiation absorbing drape (RADPAD®)

Dummy group

Active Comparator group

Description:

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.

Treatment:

Device: (sham) radiation absorbing drape (RADPAD®)

Control goup

No Intervention group

Description:

Only conventional protection measurements.