RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization. A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices. Follow-up of the subject will take place 60 days after the index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Each of the devices will be assessed for radial artery hemostasis.
University of Szeged, Department of Invasive Cardiology
Szeged, Csongád-Csanád, Hungary
Department of Cardiology and Cardiac Surgery
Debrecen, Hajdú-Bihar, Hungary
Semmelweis University Heart and Vascular Center
Budapest, Hungary
Radial artery occlusion
Frequency of radial artery occlusion after hemostasis
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery occlusion
Frequency of radial artery occlusion after hemostasis
Time frame: 60 days (+/-10 days) post-procedure
Radial artery (pseudo)aneurysm formation
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery (pseudo)aneurysm formation
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Time frame: 60 days (+/-10 days) post-procedure
Radial artery fistula formation
Frequency of radial artery arteriovenous fistula formation after hemostasis
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery fistula formation
Frequency of radial artery arteriovenous fistula formation after hemostasis
Time frame: 60 days (+/-10 days) post-procedure
Radial artery bleeding
Bleeding from the radial artery puncture, classified via the EASY method
Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery bleeding
Bleeding from the radial artery puncture, classified via the EASY method
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 60 days (+/-10 days) post-procedure
Initial compression time of hemostatsis device
Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis
Time frame: Up to 30 minutes post-procedure
Overall compression time
Overall time (in minutes) of device use as a hemostatis tool
Time frame: Up to 24 hours post-procedure
Number of compression devices needed
Overall number of compression devices needed for hemostatis
Time frame: Up to 24 hours post-procedure