Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial

Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07467720

Acronym

SECURE

Enrollment

Registered

2026-03-12

Start date

2026-08-20

Completion date

2027-05-15

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Protection

Brief summary

Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial

Detailed description

An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.

Interventions

DEVICERampart IC System

RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Individuals who are not yet adults, pregnant women, or prisoners. * Urgent and emergent cases

Design outcomes

Primary

Measure	Time frame	Description
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.	Intraprocedural	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

Measure	Time frame	Description
The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.	Intraprocedural	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.

Countries

United States

Contacts

CONTACTBonnie Ostergren

bonnie.ostergren@bswhealth.org469-814-4181

CONTACTSarah Hale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026