The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,000
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
Powered for non-inferiority against BioFreedom (control), is a composite of cardiac death, myocardial infarction and definite/probable stent thrombosis. The combined clinical outcome of cardiac death, MI or stent thrombosis
Time frame: 1 year post-procedure
Target Lesion Failure
Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical methods
Time frame: 2 year post-procedure
Procedure Success
Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
Time frame: 2 year post-procedure
Cardiac Death
All deaths including cardiac death
Time frame: 2 year post- procedure
Major Cardiac Event
Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Time frame: 2 year post- procedure
Myocardial Infarction
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Time frame: 2 year post-procedure
Target Vessel Failure
Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
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Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Bundaberg Cardiology - Friendly Society Private Hospital
Bundaberg, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Adelaide Cardiology
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Saint Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
...and 79 more locations
Time frame: 2 year post-procedure
Revascularization
All revascularizations (TLR, TVR and non-TVR)
Time frame: 2 year post-procedure
Stent Thrombosis
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Time frame: 2 year post-procedure
Bleeding
Bleeding per BARC criteria
Time frame: 2 year post-procedure
Stroke
Stroke
Time frame: 2 year post-procedure
Lesion Success
The attainment of \<30% residual stenosis by QCA (or \< 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Time frame: 2 year post-procedure
Device success
Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Time frame: 2 year post-procedure