N/A
Completed N=30
Transradial-Band Pilot Study
Radial Artery Incision Site Closure
Source: ClinicalTrials.gov NCT04709341 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Percentage of Participants With Bleeding — 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Bleeding |
0; 1 | — |
| PRIMARY Left Radial Artery Occlusion |
0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04709341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.