Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorTransradial Technologies, LLC

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

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators