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NCT Number: NCT07467720

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

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Key information

Conditions

Radiation Protection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White The Heart Hospital- Plano

Plano, Texas, 75093, United States

Location contact

Bonnie Ostergren

CONTACT

[email protected]

469-814-4181

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rampart IC System

Device

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

Primary outcomes

  1. The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.

    Time frame: 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 outcomes

  1. The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie Ostergren

CONTACT

[email protected]

469-814-4181

Sarah Hale

CONTACT

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Acronym: SECURE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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