Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI (MAHI-SEAL-60)
12. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
300
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFHS plus pneumatic radial compression
Tidsramme: Immediately after the intervention
|
PFHS plus pneumatic radial compression initiated at 20 minutes, compared with pneumatic radial compression alone.
|
Immediately after the intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to patient discharge between trial arms
Tidsramme: 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
Tidsramme: Immediately after the intervention
|
Plethysmography and pulse oximetry with reverse Barbeau testing (A-D classification).
|
Immediately after the intervention
|
Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. januar 2032
Studieafslutning (Anslået)
1. juni 2032
Datoer for studieregistrering
Først indsendt
23. juli 2026
Først indsendt, der opfyldte QC-kriterier
12. august 2026
Først opslået (Faktiske)
17. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MAHI-SEAL-60 Trial
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