At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial
In Brief
A clinical study evaluating RADPAD for Radiation Exposure. Completed, enrolled 1,000 participants across 1 site.
Detailed Summary
The purpose of this study is to examine the impact of the RADPAD in proximal operators in a contemporary cardiac catheterization laboratory (CCL), during diagnostic, coronary and structural cardiac catheterization procedures, in a large prospective, randomized controlled trial. Up to 1,000 patient-cases and up to 100 proximal operator-subjects expected to be enrolled across 1 site. The proximal operator cohort is expected to include a few interventional cardiologist attending physicians, interventional cardiology fellows, cardiovascular disease fellows and physician assistants performing multiple cases each, which in total would amount to 1,000 cases performed by 100 proximal operators. The primary outcome of interest was relative exposure of the proximal operator between the guideline directed radiation protocols and RADPAD use vs. guideline directed radiation protocols alone.
Study Details
Timeline
Interventions
The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is a sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and Digital subtraction angiography (DSA) settings.