Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Control goup | No Intervention | Only conventional protection measurements. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (sham) radiation absorbing drape (RADPAD®) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary operator radiation exposure (mSv) | immediately post-procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29089313 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patient, operator and investigator are blinded to dummy drape vs RADPAD.