Transradial-Band Pilot Study
NCT04709341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-04-06
Summary
In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.
Conditions
- Radial Artery Incision Site Closure
Interventions
- DEVICE
-
TR Band 60MIN
TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
- DEVICE
-
TR Band 120MIN
TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Sponsors & Collaborators
-
Medical University of South Carolina
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-03
- Primary Completion
- 2024-02-01
- Completion
- 2024-02-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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