Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rampart IC System.
- Who it may be relevant to
- Registry conditions: Radiation Protection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Overview
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Detailed description
An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.
Interventions
- 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.
Primary outcome measures
- The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. [Time frame: Intraprocedural]
Secondary outcome measures (1)
- The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge. [Time frame: Intraprocedural]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Baylor Scott & White The Heart Hospital- Plano — Plano
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
Identifiers
NCT: NCT07467720 · 026-232