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Procedure
Early vs Standard TR Band Removal for Radial Artery Closure
N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether it's safe to remove a medical device from the body earlier than usual.
Who is the study for?
This trial is for adults over 18 with a left radial artery width of at least 1.6 mm, normal blood clotting ability (INR < 1.5, platelets >50,000/uL, prothrombin time <15s), and no high bleeding risk or unsuitable arteries as per Barbeau test type D.
What is being tested?
The study compares two durations for wearing the TR Band after radial artery procedures: one group has it on for a shorter period (deflation starts at 15 mins) versus the standard care group (starts deflation at 60 mins).
What are the potential side effects?
Potential side effects may include discomfort from the band, bruising or bleeding where the band was placed, and less commonly vascular complications like reduced blood flow due to improper band size or pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Left radial artery occlusion
Percentage of participants with bleeding
Percentage of participants with significant hematomas
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 Intervention
Group II: Group BActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TR Band 60MIN
2021
N/A
~30
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
979 Previous Clinical Trials
7,400,964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The way you manage your blood thinning medication before the procedure will follow the guidelines by Patel et al.If there is a high risk of excessive bleeding.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.