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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
The Rex Medical CloserTM Vascular Closure System is currently being investigated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures or interventional procedures using up to a 7 French procedural sheath. This study will evaluate the safety and efficacy of the Rex Medical CloserTM Vascular Closure System to close the femoral artery access site of subjects who have undergone diagnostic angiography procedures with early ambulation and discharge as soon as possible after sheath removal and device placement.
Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
Asunción, Paraguay
Time to Ambulation
Time to Ambulation - in minutes, defined as the time from when hemostasis is achieved to the time when ambulation is achieved (patient standing and walking at least 6.1 meters \[20 feet\] without re-bleeding).
Time frame: Day 0
Frequency of Major Adverse Events through 30 days
The primary safety endpoint is the frequency of Major Adverse Events through 30 days, defined as one of the following events related to the use of the investigational device: a hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention or a retroperitoneal bleed.
Time frame: 30 days
Time to Hemostasis
Time to Hemostasis - in minutes, defined as the time from when the delivery system releases both sutures, which are attached to the sealing member, to the time that hemostasis (absence of expanding or developing hematoma) is achieved
Time frame: Day 0
Placement Technical Success
Placement Technical Success - defined as the successful deployment of the device at the intended placement site such that hemostasis is achieved.
Time frame: Day 0
Clinical Success
Clinical Success - evaluated from the time of device deployment, and defined as Placement Technical Success in the absence of any major safety endpoint including subsequent hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention, or retroperitoneal bleeding.
Time frame: Day 0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.