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NCT07768839
Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI
Conditions: Coronary Angiogram, Early Discharge Trans Radial Angiography
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
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.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years • Undergoing trans radial coronary angiography with or without PCI
* Radial 6Fr Prelude sheath used for the procedure
* Planned use of Inflation band (Sunny Medical) radial compression device for hemostasis
* Able to provide informed consent
* Adequate collateral circulation per institutional radial access screening (consistent with device contraindications).
Exclusion Criteria:
* On a GPIIB/IIIA inhibitor
* Known hypersensitivity to device materials
* Infection or serious skin disease at puncture site
* Abnormal collateral circulation test / insufficient dual arterial supply
* Inability to complete study assessments before discharge
* Conversion to femoral access or need for alternate hemostasis device
* Prior radial artery harvest or known chronic radial artery occlusion in the study limb (per operator judgement).
Source: ClinicalTrials.gov (NCT07768839). StuddyBuddy aggregates publicly available trial information.