Coronary Artery Disease Clinical Trial
Official title:
Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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