NCT02234830

Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 818 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.

Detailed description

Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Exoseal closure device	Closure device for femoral artery access closure
DEVICE	Angioseal closure device	Closure device for femoral artery access closure

Timeline

• Start date: 2012-12-21
• Primary completion: 2016-05-14
• Completion: 2017-05-14
• First posted: 2014-09-09
• Last updated: 2017-06-01

Locations

2 sites across 1 country: Denmark