About this trial
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Member of the interventional care team
Elective peripheral procedure
The access site is the femoral artery
The treatment area is at or distal to the iliac artery
Disqualifiers
Individuals who are not yet adults, pregnant women, or prisoners.
Urgent and emergent cases
Trial design
Parallel
Treatments tested in this trial
Rampart IC System
DeviceRAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases.
Treatment groups
Trial outcomes
Primary outcomes
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. The two methods being compared are traditional lead aprons and shields and the RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
Secondary outcomes
The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.
The secondary endpoint will be to compare radiation exposure on a per body segment analysis on the care team using a Raysafe i3 dosimeter badge. The investigators will compare traditional lead aprons and ancillary shields to the RAMPART IC System with optional lead aprons.
Sponsors and contacts
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