Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial
SECURE
1 other identifier
interventional
75
1 country
1
Brief Summary
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedStudy Start
First participant enrolled
August 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2027
August 21, 2026
August 1, 2026
9 months
March 9, 2026
August 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Intraprocedural
Secondary Outcomes (1)
The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.
Intraprocedural
Study Arms (2)
Traditional Lead Apron and Shields
NO INTERVENTIONThese procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases.
Rampart IC System
ACTIVE COMPARATORThe study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
Interventions
RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Individuals who are not yet adults, pregnant women, or prisoners.
- Urgent and emergent cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor Scott & White The Heart Hospital- Plano
Plano, Texas, 75093, United States
Related Publications (3)
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: 19214981BACKGROUNDOcc Med. 2010;60(6):464-9
BACKGROUNDCirculation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273
BACKGROUND
Central Study Contacts
Sarah Hale
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2026
First Posted
March 12, 2026
Study Start
August 20, 2026
Primary Completion (Estimated)
May 15, 2027
Study Completion (Estimated)
May 15, 2027
Last Updated
August 21, 2026
Record last verified: 2026-08