Coronary AngiogramMAHI-SEAL-60NCT07768839

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

A study testing Experimental: PFHS + pneumatic radial compression device and Pneumatic radial compression device alone. in people with Coronary Angiogram and Early Discharge Trans Radial Angiography, run by University of Alberta.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Angiogram, Early Discharge Trans Radial Angiography
What is being tested?: Experimental: PFHS + pneumatic radial compression device and Pneumatic radial compression device alone.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: No sites listed yet
Study dates: 1 Oct 2026to 1 Jun 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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).

About this study

Official title: 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.

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.

Conditions: Coronary Angiogram, Early Discharge Trans Radial Angiography
Being tested: Experimental: PFHS + pneumatic radial compression device, Pneumatic radial compression device alone.
Keywords: Angiogram, Angioplasty, Radial angiogram, Potassium Ferrate Hemostatic Sealant (PFHS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07768839
Study group	Role	What they receive
PFHS + pneumatic radial compression device.	Experimental	Not described Receives: Device: Experimental: PFHS + pneumatic radial compression device
Pneumatic radial compression device alone.	Active comparator	Not described Receives: Device: Pneumatic radial compression device alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

PFHS plus pneumatic radial compression
PFHS plus pneumatic radial compression initiated at 20 minutes, compared with pneumatic radial compression alone.
Measured: Immediately after the intervention

Secondary outcomes (2)

Time to patient discharge between trial arms
Time to patient discharge between trial arms.
Measured: 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).
Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20261 Jun 2032

First posted17 Aug 2026
Study start1 Oct 2026 (estimated)
Primary completion1 Jan 2032 (estimated)
Study completion1 Jun 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary AngiogramStudies of the same condition, open and under way.
More trials run by University of AlbertaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07768839
Sponsor's protocol ID: MAHI-SEAL-60 Trial
Acronym: MAHI-SEAL-60
Status last verified: Aug 2026
First submitted: 23 Jul 2026
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07768839
Acronym / sponsor ID: MAHI-SEAL-60 / MAHI-SEAL-60 Trial
Conditions: Coronary Angiogram, Early Discharge Trans Radial Angiography
Keywords: Angiogram, Angioplasty, Radial angiogram, Potassium Ferrate Hemostatic Sealant (PFHS)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: University of AlbertaUniversity, hospital or other
Study start: 1 Oct 2026 (estimated)
Primary completion: 1 Jan 2032 (estimated)
Study completion: 1 Jun 2032 (estimated)
First posted: 17 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PFHS + pneumatic radial compression device.	Experimental	Device: Experimental: PFHS + pneumatic radial compression device
Pneumatic radial compression device alone.	Active comparator	Device: Pneumatic radial compression device alone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: PFHS + pneumatic radial compression devicePFHS 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.	Device	PFHS + pneumatic radial compression device.
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	Device	Pneumatic radial compression device alone.

Primary outcome

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.

2 secondary outcomes

Time to patient discharge between trial arms
Time frame: Immediately after the intervention
Radial artery patency at discharge compared between both trial arms
Time frame: Immediately after the intervention

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Coronary Angiogram

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Computed Tomography Angiography, Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFHS plus pneumatic radial compression (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07768839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.