NCT01389375

Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,524 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?

Detailed description

Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest. However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature. This trial compares, in a randomised design two novel vascular closure devices (FemoSeal \& ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	FemoSeal®	Closure device for femoral artery access closure
DEVICE	ExoSeal®	Closure device for femoral artery access closure
OTHER	Manual compression	Conventional manual compression

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-07-08
• Last updated: 2016-06-10

Locations

2 sites across 1 country: Germany