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

NCT07467720 — Not applicable, Recruiting, 75 participants, Baylor Research Institute

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

Registry	NCT07467720, acronym SECURE
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	75 (Estimated)
Sponsor	Baylor Research Institute (Other)
Conditions	Radiation Protection
Interventions	Rampart IC System (Device)
Dates	start 2026-08-20, primary completion 2027-05-15 (estimated), completion 2027-05-15 (estimated), first posted 2026-03-12, last updated 2026-08-21
Locations	1 site in United States

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Traditional Lead Apron and Shields	No intervention		These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases.
Rampart IC System	Active comparator	Device: Rampart IC System	The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.

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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Baylor Scott & White The Heart Hospital- Plano	Plano, Texas	United States	Recruiting

+Publications

Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801. PMID 19214981
Occ Med. 2010;60(6):464-9
Circulation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273