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Purpose

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

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Baylor Scott & White The Heart Hospital- Plano
Plano, Texas 75093
Contact:
Bonnie Ostergren
469-814-4181
bonnie.ostergren@bswhealth.org

More Details

Status
Recruiting
Sponsor
Baylor Research Institute

Study Contact

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

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.