NCT01873898

Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bleeding

Interventions

Type	Name	Description
DEVICE	Rex Medical Closer™ Vascular Closure System	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-06-10
• Last updated: 2017-09-28

Locations

1 site across 1 country: Paraguay

Regulatory

• FDA-regulated device study