About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Suction-Activated Patent Hemostasis (SAPH) Device
Treatment groups
Locations
Sponsors and collaborators
Transradial Technologies, LLC
Lead sponsor
RARAS CRO
Collaborator