Radial Artery Incision Site Closure
Conditions
Brief 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.
Interventions
DEVICETR Band 60MIN
TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
DEVICETR Band 120MIN
TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Bleeding | an average of 12 hours post procedure | Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma |
| Left Radial Artery Occlusion | 30 days post procedure | Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test |
Countries
United States
Participant flow
Recruitment details
The study was conducted at MUSC's VIR Department, including University Hospital and outpatient clinics. Patients scheduled for angiographic procedures were screened for eligibility via Barbeau tests, ultrasounds, and lab reviews. Informed consent was obtained during consultations or in recovery bays. Recruitment involved 30 randomized patients divided into expedited and standard protocol groups.
Pre-assignment details
No significant events, such as washout or run-in periods, occurred after participant enrollment and before group assignment. All participants who met eligibility criteria, including acceptable Barbeau test results, ultrasound evaluation, and coagulation parameters, were randomized directly into the expedited or standard protocol groups. No exclusions were reported after enrollment and prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Group A 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 | 15 |
| Group B TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Continuous | 61.5 years STANDARD_DEVIATION 16.67 | 64.2 years STANDARD_DEVIATION 11.7 | 62.8 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Left Radial Artery Occlusion
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Time frame: 30 days post procedure
Population: No patients presented with this symptom during the TR Band Procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Left Radial Artery Occlusion | 0 Participants |
| Group B | Left Radial Artery Occlusion | 0 Participants |
Primary
Percentage of Participants With Bleeding
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Time frame: an average of 12 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Percentage of Participants With Bleeding | 0 Participants |
| Group B | Percentage of Participants With Bleeding | 1 Participants |
Primary
Percentage of Participants With Bleeding
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Percentage of Participants With Bleeding | 0 Participants |
| Group B | Percentage of Participants With Bleeding | 1 Participants |