Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia
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 verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
Interventions
DEVICEMDT-4107 Drug Eluting Stent
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Sponsors
Medtronic Japan Co., Ltd.
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm
Exclusion criteria
* Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; white blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl * Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (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 transient ischemic attack (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 |
|---|---|---|
| In-stent Late Lumen Loss (LLL) | Post procedure, 8 Months | The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) | 12 months | Major Secondary Endpoint Target lesion fature (TLF) is 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. |
| Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis | 12 months | — |
| Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) | 8 months | — |
Countries
Japan
Participant flow
Recruitment details
The first patient and the last patient were enrolled on Mar. 23, 2009 and Oct. 30, 2009 respectively. Total 100 patients were enrolled in this study from 14 sites.
Participants by arm
| Arm | Count |
|---|---|
| Zotalolimus Eluting Sttent All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Zotalolimus Eluting Sttent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 61 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 67.7 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Japan | 100 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 100 |
| serious Total, serious adverse events | 35 / 100 |
Outcome results
Primary
In-stent Late Lumen Loss (LLL)
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
Time frame: Post procedure, 8 Months
Population: Actually a patient was excluded from this analysis because of death before 30 days follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zotarolimus Eluting Stent | In-stent Late Lumen Loss (LLL) | 0.13 mm | Standard Deviation 0.22 |
Secondary
Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)
Major Secondary Endpoint Target lesion fature (TLF) is 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
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zotarolimus Eluting Stent | Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) | 4.0 percentage of participants with TLF |
Secondary
Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)
Time frame: 8 months
Secondary
Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis
Time frame: 12 months