Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI

N/ANot Yet RecruitingNCT07768839

University of Alberta300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Coronary Angiogram Early Discharge Trans Radial Angiography

Interventions

Experimental: PFHS + pneumatic radial compression deviceDEVICE

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.DEVICE

Pneumatic radial compression device alone (no PFHS) + identical deflation protocol starts at 60 minutes for diagnostic procedures and 90 minutes for PCI procedures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

PFHS plus pneumatic radial compression

PFHS plus pneumatic radial compression initiated at 20 minutes, compared with pneumatic radial compression alone.

Time frame: Immediately after the intervention

Secondary Outcomes

Time to patient discharge between trial arms

Time to patient discharge between trial arms.

Time frame: Immediately after the intervention

Radial artery patency at discharge compared between both trial arms

Plethysmography and pulse oximetry with reverse Barbeau testing (A-D classification).

Time frame: Immediately after the intervention

Data from ClinicalTrials.gov

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