Clinical trial NCT01873898: Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
Official title: Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding
Keywords: femoral artery
access site
hemostasis
Lead sponsor: Rex Medical
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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
* Subject has planned surgeries for any reason within 90 days post- procedure
* Subject is pregnant or is lactating (non-pregnancy must be confirmed by testing)
* Has a history of a psychiatric condition, substance abuse or alcohol abuse that, in the opinion of the investigator, will potentially interfere with his or her participation
* Subject has been previously enrolled in the Rex Closer™ study
* Subject who is currently or within the previous 4 weeks been enrolled in another investigational device or drug trial
* Subject is incarcerated at the time of enrollment
* Subject where the procedural sheath has been placed through the superficial femoral artery and into the profundafemoris
* Subject where the procedure puncture site is at or distal to the bifurcation of the superficial femoral profundafemoris artery, as this may result in 1) the intravascular sealing patch catching on the bifurcation or being positioned incorrectly, and/or 2) intravascular deployment of the device into the vessel (These events may reduce blood flow through the vessel leading to symptoms of distal arterial insufficiency.)
* Subject's procedure was accessed through a vascular graft
* Subjects with uncontrolled hypertension (\> 230 mm Hg systolic)
* Subjects with small femoral artery size (Less than 5 mm in diameter)
* Subjects with stenosis \> 50% at the vicinity of the femoral arterial puncture site
* Subjects with anomalous branches or vessel abnormalities present in the vicinity of the femoral arterial puncture site

Primary outcomes:
measure: Time to Ambulation
timeFrame: Day 0
measure: Frequency of Major Adverse Events through 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Time to Hemostasis
timeFrame: Day 0
measure: Placement Technical Success
timeFrame: Day 0
measure: Clinical Success
timeFrame: Day 0
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
Study officials:
affiliation: Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References: