Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI (MAHI-SEAL-60)
August 12, 2026 updated by: University of Alberta
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)
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.
Study Overview
Status
Not yet recruiting
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.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFHS plus pneumatic radial compression
Time Frame: Immediately after the intervention
|
PFHS plus pneumatic radial compression initiated at 20 minutes, compared with pneumatic radial compression alone.
|
Immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to patient discharge between trial arms
Time Frame: Immediately after the intervention
|
Time to patient discharge between trial arms.
|
Immediately after the intervention
|
|
Radial artery patency at discharge compared between both trial arms
Time Frame: Immediately after the intervention
|
Plethysmography and pulse oximetry with reverse Barbeau testing (A-D classification).
|
Immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
January 1, 2032
Study Completion (Estimated)
June 1, 2032
Study Registration Dates
First Submitted
July 23, 2026
First Submitted That Met QC Criteria
August 12, 2026
First Posted (Actual)
August 17, 2026
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
August 12, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- MAHI-SEAL-60 Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.