Coronary Artery Disease
Conditions
Brief summary
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
Interventions
DEVICEResolute Onyx Stent - 2.25 mm - 4.0 mm
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery * Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study * Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels * Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Exclusion criteria
* Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative * History of a stroke or transient ischemic attack (TIA) within the prior 6 months * Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months * History of bleeding diathesis or coagulopathy or will refuse blood transfusions * Concurrent medical condition with a life expectancy of less than 12 months * Currently participating in an investigational drug or another device trial that has not completed the primary endpoint * Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography | 8 Months | In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Myocardial Infarction (TVMI) | 8 Months | — |
| Target Lesion Revascularization (TLR) | 8 Months | — |
| Major Adverse Cardiac Event (MACE) | 8 Months | Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods |
| Cardiac Death | 8 Months | — |
| Target Vessel Failure (TVF) | 8 Months | — |
| Stent Thrombosis (ST) | 8 Months | — |
| Cardiac Death and TVMI | 8 Months | — |
| Target Lesion Failure (TLF) | 8 Months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 66.1 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 66 / 75 |
| serious Total, serious adverse events | 27 / 75 |
Outcome results
Primary
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography | 0.24 mm | Standard Deviation 0.39 |
Secondary
Cardiac Death
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Cardiac Death | 0 Participants |
Secondary
Cardiac Death and TVMI
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Cardiac Death and TVMI | 2 Participants |
Secondary
Major Adverse Cardiac Event (MACE)
Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Major Adverse Cardiac Event (MACE) | 7 Participants |
Secondary
Stent Thrombosis (ST)
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Stent Thrombosis (ST) | 1 Participants |
Secondary
Target Lesion Failure (TLF)
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Target Lesion Failure (TLF) | 5 Participants |
Secondary
Target Lesion Revascularization (TLR)
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Target Lesion Revascularization (TLR) | 3 Participants |
Secondary
Target Vessel Failure (TVF)
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Target Vessel Failure (TVF) | 9 Participants |
Secondary
Target Vessel Myocardial Infarction (TVMI)
Time frame: 8 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Target Vessel Myocardial Infarction (TVMI) | 2 Participants |