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Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI
Sponsor: University of Alberta
Summary
This study aims to evaluate patients undergoing coronary angiography by comparing the use of Potassium Ferrate Hemostatic Sealant (PFHS) in addition to the standard of care (SOC) pneumatic radial compression device versus SOC alone. The objective is to determine whether the addition of PFHS reduces the time to successful deflation and removal of the radial compression device.
Official title: Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI. A Randomized, Single-centre, Superiority Trial at the Mazankowski Alberta Heart Institute Cardiac Catheterization Laboratory (Edmonton, Alberta, Canada)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-10-01
Completion Date
2032-06-01
Last Updated
2026-08-17
Healthy Volunteers
No
Interventions
Experimental: PFHS + pneumatic radial compression device
PFHS applied at arteriotomy + pneumatic radial compression device placement; deflation protocol starts at 20 minutes using the Stat Seal 2-step deflation method regardless of PCI procedure.
Pneumatic radial compression device alone.
Pneumatic radial compression device alone (no PFHS) + identical deflation protocol starts at 60 minutes for diagnostic procedures and 90 minutes for PCI procedures