Status:
NOT_YET_RECRUITING
Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
Lead Sponsor:
Transradial Technologies, LLC
Collaborating Sponsors:
RARAS CRO
Conditions:
Hemostasis of Arterial Punctures
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study intended to provide supportive clinical information to the nonclinical characterization and performance ...
Eligibility Criteria
Inclusion
- 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 is willing and able to sign informed consent and adhere to the protocol requirements
Exclusion
- 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
- Patient has intolerance to standard anticoagulants used in TRA procedures
- Patient has non-palpable radial pulse or Reverse Barbeau test Type D response
- Patient is participating in another investigational study
- Patient is a prisoner
- Patient, in the principal investigator's opinion, would not be able to comply with protocol requirements including self-report of comfort and 30-day follow up
- Patient is receiving glycoprotein IIb/IIIa inhibitors
- Patients with allergy to medical adhesives
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06991010
Start Date
August 1 2025
End Date
November 28 2025
Last Update
July 15 2025
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