Reduction of Catheterization Radiation Exposure Pad

Coronary Interventions Clinical Trial

— RECAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139968
• Other study ID #: RECAP-RCT
• Status: Completed
• Phase: Phase 3
• Start date: January 16, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: January 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 766
• Est. completion date: October 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All CAGs and PCI's

Exclusion Criteria:

• Other interventional procedures

Related Conditions & MeSH terms

• Coronary Interventions
• Radiation; Exposure Occupational

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
J.P.S Henriques

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary operator radiation exposure (mSv)		immediately post-procedure