NCT01911403

AGIR Study: Angio-Seal in Interventional Radiology

Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access. It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.

Detailed description

Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression. Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week). The randomization will be stratified according to the type of procedure.

Conditions

• Vascular Access Complication

Interventions

Type	Name	Description
PROCEDURE	Manual compression	Closure procedure by Manual compression
DEVICE	Angio-Seal	Closure procedure by angio-Seal

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-07-30
• Last updated: 2019-02-19
• Results posted: 2015-03-11

Locations

2 sites across 2 countries: Portugal, Spain