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 -Closerâ„¢ 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 Closerâ„¢ 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 range18 Years
SexALL
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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
*…