Radial Artery Incision Site ClosureNCT04709341
Transradial-Band Pilot Study
A study testing TR Band 60MIN and TR Band 120MIN in people with Radial Artery Incision Site Closure, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Incision Site Closure
- What is being tested?
- TR Band 60MIN and TR Band 120MIN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
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.
- Conditions
- Radial Artery Incision Site Closure
- Being tested
- TR Band 60MIN, TR Band 120MIN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR Band 60MINDevice
TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
TR Band 120MINDevice
TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Device: TR Band 60MIN |
| Group B | Active comparator | Not described Receives: Device: TR Band 120MIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Bleeding
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Measured: an average of 12 hours post procedure
Percentage of Participants With Bleeding
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Measured: 30 days post procedure
Left Radial Artery Occlusion
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start3 Feb 2021
- Primary completion1 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radial Artery Incision Site ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709341
- Sponsor's protocol ID
- 00088481
- Status last verified
- Mar 2025
- First submitted
- 12 Jan 2021
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
- ClinicalTrials.gov ID
- NCT04709341
- Acronym / sponsor ID
- 00088481
- Conditions
- Radial Artery Incision Site Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: TR Band 60MIN |
| Group B | Active comparator | Device: TR Band 120MIN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR Band 60MINTR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals | Device | Group A |
| TR Band 120MINTR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals | Device | Group B |
Primary outcome
Percentage of Participants With Bleeding
Time frame: an average of 12 hours post procedure
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Percentage of Participants With Bleeding
Time frame: 30 days post procedure
Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma
Left Radial Artery Occlusion
Time frame: 30 days post procedure
Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TR Band 60MIN and TR Band 120MIN in people with Radial Artery Incision Site Closure, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Bleeding (time frame: an average of 12 hours post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.