The purpose of this trial 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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
752
To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Saint Joseph's Hospital Health Center
East Syracuse, New York, United States
New York- Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
AnMed Health Medical Center
Anderson, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]
Time frame: One Month to one year
Number of Participants With 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 method
Time frame: One Month to One Year
Number of Participants With 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: Procedure to hospital discharge, an average of 1.3 days
All Participants Deaths Including Cardiac Death
All participants deaths including cardiac death
Time frame: One Month to One Year
Number of Patients With 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: One Month to One Year
Number of Patients With Myocardial Infarction
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Time frame: One Month to One Year
Number of Patients With Target Vessel Failure
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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.
Time frame: One Month to One Year
Number of Patients With Revascularization
All revascularizations (TLR, TVR and non-TVR)
Time frame: One Month to One Year
Number of Patients With Stent Thrombosis
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Time frame: One Month to One Year
Number of Patients With Bleeding
Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe. Grouping of BARC categories: * BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories * BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories * All BARC- This included all bleeding events BARC 1 through BARC 5
Time frame: One Month to One Year
Number of Patients With Stroke
Stroke
Time frame: One Month to One Year
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: End of Procedure, an average of 42 minutes
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: End of Procedure an average of 42 minutes