Transradial-Band Pilot Study

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Radial Artery Incision Site Closure

Treatments

Device: TR Band 120MIN

Device: TR Band 60MIN

Study type

Interventional

Funder types

Other

Identifiers

NCT04709341

00088481

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years and older
Have an acceptable Barbeau test (i.e. type A through C)
Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1)
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.
The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al16.
INR less than 1.5
Platelet count greater than 50,000 platelet/uL
Prothrombin time less than 15 seconds

Exclusion criteria

If there is an unacceptable risk of bleeding diathesis, or
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.