This is a prospective, multicenter study intended to provide supportive clinical information on the use of the SAPH device to achieve radial artery patent hemostasis after a transradial procedure.
Patient is 21 years or older.
Patient is scheduled to undergo a coronary or peripheral catheterization procedure requiring 5 or 6 Fr transradial sheath access (TRA) with planned same-day discharge
Patient has a Reverse Barbeau test result of Type A, B or C (patent radial artery)
Patient is able to understand informed consent language
Patient had a prior ipsilateral TRA procedure
Patient has scleroderma, vasculitis, or Raynaud's syndrome (primary or secondary)
Patient has cellulitis overlying radial artery
Patient requires uninterrupted oral systemic anticoagulation
Single group
Suction-Activated Patent Hemostasis (SAPH) Device
DeviceA compression device intended to achieve patient hemostasis of the radial artery
Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge
Radial artery hemostasis with patency is defined as hemostasis over the arterial puncture site with palpable distal radial pulse or prominent digital arterial waveform signal by digital plethysmography with ulnar occlusion.
Safety Endpoints - 1) Percentage of subjects with radial artery patency 2) No major device-related access site-related complications prior to discharge
Patency is defined as prominent digital arterial waveform signal by digital plethysmography with ulnar artery occlusion.
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Transradial Technologies, LLC
Lead sponsor
RARAS CRO
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
