Coronary Artery Disease
Conditions
Brief summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population. To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
Interventions
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction * Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki * Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
Exclusion criteria
* Unprotected left main disease * Subjects with planned PCI of three vessel disease * Planned two stent technique (main branch and side branch) of a bifurcation * Subjects with more than one bifurcation lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 12 Months | Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiac Death | 12 months | Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause. |
| Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) | Up to 12 months | Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI) |
| Number of Participants With Target Lesion Revascularization (TLR) | 12 months | Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization. |
| Number of Participants With Target Vessel Revascularization (TVR) | 12 months | Target Vessel Revascularization (TVR) defined as revascularization of the target vessel. |
| Number of Participants With Cardiac Death and TVMI | 12 months | Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction. |
| Number of Participants With Major Adverse Cardiac Event (MACE) | 12 months | 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. |
| Number of Participants With Target Lesion Failure (TLF) | 12 months | Target Lesion Failure (TLF) 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. |
| Number of Participants With Stent Thrombosis (ARC) Definite/Probable | 12 months | Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration \>20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days. |
Countries
Belgium, France, Slovakia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bifurcation Cohort Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm in diameter for the treatment of a bifurcation lesion with provisional stenting. | 205 |
| Total | 205 |
Baseline characteristics
| Characteristic | Bifurcation Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 118 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 159 Participants |
| Region of Enrollment Europe | 38 Participants |
| Region of Enrollment United States | 167 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 205 |
| other Total, other adverse events | 39 / 205 |
| serious Total, serious adverse events | 48 / 205 |
Outcome results
Primary
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Target Vessel Failure (TVF) | 14 Participants |
Secondary
Number of Participants With Cardiac Death
Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Cardiac Death | 3 Participants |
Secondary
Number of Participants With Cardiac Death and TVMI
Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Cardiac Death and TVMI | 9 Participants |
Secondary
Number of Participants With Major Adverse Cardiac Event (MACE)
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: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Major Adverse Cardiac Event (MACE) | 17 Participants |
Secondary
Number of Participants With Stent Thrombosis (ARC) Definite/Probable
Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration \>20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Stent Thrombosis (ARC) Definite/Probable | 0 Participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure (TLF) 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: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Target Lesion Failure (TLF) | 13 Participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Target Lesion Revascularization (TLR) | 7 Participants |
Secondary
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) | 6 Participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifurcation Cohort | Number of Participants With Target Vessel Revascularization (TVR) | 8 Participants |