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 that allows the use of a 2.0 mm diameter stent.
Interventions
DEVICEResolute Onyx Stent - 2.0 mm
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
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, stenting, & emergent coronary artery bypass graft (CABG) surgery * Must have evidence of ischemic heart disease * Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent * 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 |
|---|---|---|
| Number of Participants With Target Lesion Failure at 12 Months Post-Procedure | 12 Months | Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure | 12 Months | TVMI defined as Q Wave or non-Q Wave MI |
| Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure | 12Months | — |
| Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure | 24 Months | — |
| Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure | 12 Months | — |
| Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure | 12 Months | — |
| Number of Participants With Cardiac Death at 24 Months Post Procedure | 24 Months | — |
| Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure | 24 Months | TVMI defined as Q Wave or non-Q Wave MI |
| Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure | 24 Months | — |
| Number of Participants With Cardiac Death at 12 Months Post Procedure | 12 Months | — |
| Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure | 24 Months | — |
| Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure | 36 Months | — |
| Number of Participants With Cardiac Death at 36 Months Post Procedure | 36 Months | — |
| Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure | 36 Months | TVMI defined as Q Wave or non-Q Wave MI |
| Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure | 36 Months | — |
| Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure | 36 Months | — |
| Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure | 36 Months | — |
| Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure | 24 Months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System \>
\> Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 70 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 67.3 Years STANDARD_DEVIATION 9.6 |
| BMI | 29.0 kg/m2 STANDARD_DEVIATION 6.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized White | 82 Participants |
| Region of Enrollment Japan | 15 participants |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 101 |
| other Total, other adverse events | 43 / 101 |
| serious Total, serious adverse events | 63 / 101 |
Outcome results
Primary
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Lesion Failure at 12 Months Post-Procedure | 5 Participants |
Secondary
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
Time frame: 12Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure | 5 Participants |
Secondary
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure | 14 Participants |
Secondary
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure | 15 Participants |
Secondary
Number of Participants With Cardiac Death at 12 Months Post Procedure
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Cardiac Death at 12 Months Post Procedure | 0 Participants |
Secondary
Number of Participants With Cardiac Death at 24 Months Post Procedure
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Cardiac Death at 24 Months Post Procedure | 2 Participants |
Secondary
Number of Participants With Cardiac Death at 36 Months Post Procedure
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Cardiac Death at 36 Months Post Procedure | 2 Participants |
Secondary
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure | 0 Participants |
Secondary
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure | 0 Participants |
Secondary
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure | 0 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure | 13 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure | 14 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure | 5 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure | 14 Participants |
Secondary
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure | 15 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure | 3 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure | 4 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure | 4 Participants |