Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure (NCT06991010) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
50 participantsStarted 2025-08-01
Plain-language summary
This is a prospective, multicenter study intended to provide supportive clinical information on the use of the SAPH device to achieve radial artery patent hemostasis after a transradial procedure.
Who can participate
Age range
21 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 is 21 years or older.
. Patient is scheduled to undergo a coronary or peripheral catheterization procedure requiring 5 or 6 Fr transradial sheath access (TRA) with planned same-day discharge
. Patient has a Reverse Barbeau test result of Type A, B or C (patent radial artery)
. Patient is able to understand informed consent language
. Patient is willing and able to sign informed consent and adhere to the protocol requirements
Exclusion criteria
. Patient had a prior ipsilateral TRA procedure
. Patient has scleroderma, vasculitis, or Raynaud's syndrome (primary or secondary)
. Patient has intolerance to standard anticoagulants used in TRA procedures
. Patient has non-palpable radial pulse or Reverse Barbeau test Type D response
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
Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge
Timeframe: 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure.
2
Safety Endpoints - 1) Percentage of subjects with radial artery patency 2) No major device-related access site-related complications prior to discharge
Timeframe: 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure