Coronary Angiogram, Early Discharge Trans Radial Angiography
Conditions
Keywords
Angiogram, Angioplasty, Radial angiogram, Potassium Ferrate Hemostatic Sealant (PFHS)
Brief 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.
Detailed description
Trans radial access is commonly used for coronary angiography and Percutaneous Coronary Intervention (PCI) because it lowers bleeding risk and allows faster recovery compared with femoral access. However, achieving safe hemostasis while keeping the radial artery open is important, as prolonged or excessive compression can lead to radial artery occlusion. At MAHI, hemostasis is currently managed with a pneumatic compression device and a 60-90 minute compression period before deflation. Reducing the time to safe device deflation and removal could improve patient comfort, reduce nursing workload, and support earlier discharge. This is particularly important in a centralized healthcare system like Alberta's, where many patients travel long distances for care and may benefit from shorter and more predictable recovery times.
Interventions
DEVICEExperimental: 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.
DEVICEPneumatic 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
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFHS plus pneumatic radial compression | Immediately after the intervention | PFHS plus pneumatic radial compression initiated at 20 minutes, compared with pneumatic radial compression alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to patient discharge between trial arms | Immediately after the intervention | Time to patient discharge between trial arms. |
| Radial artery patency at discharge compared between both trial arms | Immediately after the intervention | Plethysmography and pulse oximetry with reverse Barbeau testing (A-D classification). |
Outcome results
None listed