Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambul… (NCT01873898) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
Paraguay30 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with early ambulation and discharge.
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:
* Subject is \> 18 years of age.
* Subject is able to undergo diagnostic angiography procedure and is found suitable to receive such a device at the femoral arterial puncture site in order to reduce time to hemostasis.
* Subject or his/her legal guardian understands the nature of the procedure, and provides written informed consent prior to the procedure.
* Subject is available and willing to participate in follow-up through 30 days post femoral closure.
Exclusion Criteria:
* Subject with known allergies to polylactic acid (PLA), polyglycolic acid (PGA) or polydioxanone (PDO) polymers
* Subject with severe acute non-cardiac systemic disease
* Subject with evidence of systemic infection
* Subject where bacterial contamination of the procedural sheath or surrounding tissues may have occurred as this may increase risk of infection
* Subject with coagulopathy (bleeding disorders, including thrombocytopenia, hemophilia, etc.)
* Subject taking thrombolytic medication which reduces fibrinogen to less than 100 mg/dl
* Subject who has had a previous arterial access in the femoral artery on the treatment side with an existing hematoma \>5 cm in diameter
* Subject who is unable to ambulate at baseline
* Subject who has had another closure device used in the treatment side within the previous 90 days
* Subject who requires re-entry of the treatment side planned within the next 90 days post-procedure
* Subject has a history of surgical repair on the treatment side
*…
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.