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Not yet recruitingNCT07768839MAHI-SEAL-60Updated Aug 17, 2026

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

An interventional study of Experimental: PFHS + pneumatic radial compression device and Pneumatic radial compression device alone. in Coronary Angiogram and Early Discharge Trans Radial Angiography, sponsored by University of Alberta. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by University of Alberta · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Angiogram
  • Early Discharge Trans Radial Angiography

Keywords

  • Angiogram
  • Angioplasty
  • Radial angiogram
  • Potassium Ferrate Hemostatic Sealant (PFHS)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    PFHS + pneumatic radial compression device.

    Device: Experimental: PFHS + pneumatic radial compression device

  • Active comparator
    Pneumatic radial compression device alone.

    Device: Pneumatic radial compression device alone.

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

05

What researchers measure

Primary outcomes

  1. 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

  1. Time to patient discharge between trial arms

    Time to patient discharge between trial arms.

    Time frame: Immediately after the intervention

  2. 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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07768839
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jan 1, 2032 (estimated)
Completion
Jun 1, 2032 (estimated)
Last update
Aug 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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