Transradial-Band Pilot Study (NCT04709341) | Clinical Trial Compass
CompletedNot Applicable
Transradial-Band Pilot Study
United States30 participantsStarted 2021-02-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.