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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,524
Closure device for femoral artery access closure
Closure device for femoral artery access closure
Conventional manual compression
Deutsches Herzzentrum Muenchen
Munich, Germany
Klinikum rechts der Isar
Munich, Germany
Composite of arterial access related complications
Composite of arterial access related complications, defined as the composite of: * Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm * Pseudoaneurysm * AV-Fistula * Major bleeding * Critical limb ischemia * Local infection * Surgical repair * Revascularisation
Time frame: 30 days
Time to hemostasis, from sheath removal to complete hemostasis
Time frame: 30 days
Device deployment failure
Time frame: 30 days
Need for repeated manual compression after end of closure procedure
Time frame: 30 days
Cost-benefit Analysis
Time frame: 30 days
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