Comparing TR Band to Statseal in Conjunction With TR Band II (NCT04046952) | Clinical Trial Compass
TerminatedNot Applicable
Comparing TR Band to Statseal in Conjunction With TR Band II
Stopped: Interim analysis at 50% of planned enrollment met prespecified critieria.
United States443 participantsStarted 2019-10-10
Plain-language summary
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transradial procedures. It is believed that the use of both devices in combination compared to the hemostasis band (TR band) alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that you would need to wear the hemostasis band.
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:
* Patient undergoing diagnostic angiography or PCI via the radial artery
* Patients with a Barbeau test prior to the procedure showing pattern A,B,or C.
Exclusion Criteria: any one of the following...
* Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
* Use of a hemostasis method or device besides the TR Band.
* Patients undergoing catheterization from the femoral, brachial, ulnar, or distal radial (snuffbox) artery approach.
* Use of an anticoagulant other than unfractionated heparin or bivalirudin.
* Any use of glycoprotein inhibitors or cangrelor.
* Use of sheathless guides.
* Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral arm.
* Any physical deformity or trauma / injury of either wrist that would prevent proper placement or function of the hemostasis band.
* Raynaud's syndrome or known peripheral vascular disease of the forearm.
* Inability of the patient to personally consent for the study. (no surrogate consent)
* History or presence of Radial Artery Occlusion.
* Barbeau test showing Pattern D.
* Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.
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.
What they're measuring
1
Time to Hemostasis Using the Hemostasis Management System (HMS)
Timeframe: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.