Early vs Standard TR Band Removal for Radial Artery Closure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm.

INR less than 1.5

Age 18 years and older

+5 more

Exclusion Criteria

If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.

If there is a high risk of excessive bleeding.

Participant Groups

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).

2Treatment groups

Experimental Treatment

Active Control

Group I: Group AExperimental Treatment1 Intervention

Group II: Group BActive Control1 Intervention