Recruiting

Radiation Exposure Reduction

Sponsor:

Baylor Research Institute

Code:

NCT07467720

Conditions

Radiation Protection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Rampart IC System

Study Details

Brief summary:

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

Conditions

Radiation Protection

Study ID

NCT07467720

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

May 15, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Traditional Lead Apron and Shields

These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases.

active comparator: Rampart IC System

The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.

Interventions

Rampart IC System

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

Primary outcome measure

  • The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. [ Time Frame: Intraprocedural ]

Central Contacts and Locations

Central contacts

Bonnie Ostergren

469-814-4181bonnie.ostergren@bswhealth.org

Locations

Baylor Scott & White The Heart Hospital- Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Bonnie Ostergren

469-814-4181bonnie.ostergren@bswhealth.org

More Information

Sponsor

Baylor Research Institute

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-08-21.