NCT02136004

The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Rex Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.

Detailed description

The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.

Conditions

• Surgical Wound

Interventions

Type	Name	Description
DEVICE	Closer VSS	At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-05-12
• Last updated: 2017-10-27
• Results posted: 2016-12-29

Locations

12 sites across 1 country: United States