Coronary Artery Disease
Conditions
Keywords
TARGET VESSEL REVASCULARIZATION (TVR), MYOCARDIAL INFARCTION (MI), TARGET VESSEL FAILURE (TVF), TARGET LESION REVASCULARIZATION (TLR), TARGET LESION FAILURE (TLF), STENT THROMBOSIS, RESTENOTIC LESION, PERCUTANEOUS CORONARY INTERVENTION (PCI)
Brief summary
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.
Detailed description
The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.
Interventions
DEVICEResolute Zotarolimus-Eluting Coronary Stent
Implantation of a Resolute Zotarolimus-Eluting Coronary 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
General and Angiographic Inclusion Criteria highlights: * Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery * Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study * Informed consent * Patient agrees to comply with specified follow-up evaluations at same investigational site * Single target lesion or two target lesions located in separate coronary arteries * De novo lesion(s) in native coronary artery(ies) * Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent) * Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent) General and Angiographic
Exclusion criteria
highlights: * Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; WBC count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl * Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB \> lab upper limit of normal) * Previous PCI of target vessel(s) within 9 months prior to the procedure * Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure * History of stroke or TIA within prior 6 months * Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints * Inability to comply with required trial antiplatelet regimen * Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent * Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis * Unprotected left main coronary artery disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 12 Months | Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 12 months | Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods). |
| Major Adverse Cardiac Event (MACE) | 12 months | Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods). |
| Death | 12 months | — |
| Target Vessel MI | 12 months | Target Vessel MI (as determined by extended historical and ARC definitions). |
| Stent Thrombosis (ST) | 12 months | Stent Thrombosis (ST) (as determined by historic and ARC definitions). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Enrollment Group All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:
2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.
Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG). | 1,402 |
| 38 mm Length Sub-study All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available. | 114 |
| Total | 1,516 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 38 mm Length Group | Death | 0 | 3 |
| Primary Enrollment Group | Death | 18 | 0 |
| Primary Enrollment Group | Withdrawal by Subject | 13 | 0 |
Baseline characteristics
| Characteristic | Primary Enrollment Group | 38 mm Length Sub-study | Total |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.7 | 64.8 years STANDARD_DEVIATION 9.7 | 64.5 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 1402 participants | 114 participants | 1516 participants |
| Sex: Female, Male Female | 444 Participants | 30 Participants | 474 Participants |
| Sex: Female, Male Male | 958 Participants | 84 Participants | 1042 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 724 / 1,402 | 67 / 114 |
| serious Total, serious adverse events | 509 / 1,402 | 71 / 114 |
Outcome results
Primary
Target Lesion Failure (TLF)
Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (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 (NUMBER) |
|---|---|---|
| Primary Enrollment Group | Target Lesion Failure (TLF) | 4.7 percentage of participants |
Secondary
Death
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group | Death | 1.3 percentage of participants |
Secondary
Major Adverse Cardiac Event (MACE)
Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group | Major Adverse Cardiac Event (MACE) | 5.5 percentage of participants |
Secondary
Stent Thrombosis (ST)
Stent Thrombosis (ST) (as determined by historic and ARC definitions).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group | Stent Thrombosis (ST) | 0.1 percentage of participants |
Secondary
Target Vessel Failure (TVF)
Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group | Target Vessel Failure (TVF) | 6.3 percentage of participants |
Secondary
Target Vessel MI
Target Vessel MI (as determined by extended historical and ARC definitions).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group | Target Vessel MI | 1.4 percentage of eligible participants |