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

March 16, 2026 updated by: Baylor Research Institute

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sarah Hale

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Catheter Cardiovasc Interv. 2009;73(3): 432-438. https://doi.org/10.1002/ccd.21801
  • Occ Med. 2010;60(6):464-9
  • Circulation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 026-232

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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