NCT03139968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
766

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

April 28, 2017

Last Update Submit

January 30, 2023

Conditions

Radiation; Exposure OccupationalCoronary Interventions

Outcome Measures

Primary Outcomes (1)

  • Primary operator radiation exposure (mSv)

    immediately post-procedure

Study Arms (3)

Radiation absorbing drape

EXPERIMENTAL

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.

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

Dummy group

ACTIVE COMPARATOR

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.

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

Control goup

NO INTERVENTION

Only conventional protection measurements.

Interventions

(sham) radiation absorbing drape (RADPAD®)DEVICE
Dummy groupRadiation absorbing drape

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All CAGs and PCI's

You may not qualify if:

  • Other interventional procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (1)

  • Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, Bekker RJ, van Hattum JC, Wykrzykowska JJ, Vis MM, Koch KT, de Winter RJ, Piek JJ, Henriques JPS. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017 Nov;10(11):e006058. doi: 10.1161/CIRCINTERVENTIONS.117.006058.

    PMID: 29089313DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Patient, operator and investigator are blinded to dummy drape vs RADPAD.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. dr. J.P.S. Henriques

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 4, 2017

Study Start

January 16, 2017

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

NL(1)