Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia
Conditions
Keywords
Medtronic, Japan, Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease, Small Vessel Stent
Brief summary
The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
Detailed description
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
Interventions
DEVICEMDT-4107 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
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 2.25 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 myocardial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(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 |
|---|---|---|
| Target Lesion Failure(TLF) | 9 month | Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss | Baseline and 9 months | Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month. |
| Binary Angiographic Restenosis | Baseline and 9 month | Defined as =\> 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used. |
| MACE (Major Adverse Cardiac Event) | Baseline and 9 month | Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods. |
| Percent Diameter Stenosis | Baseline and 9 month | The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA). |
| Clinical Endpoints | 5 Years | Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis |
| Minimum Luminal Diameter | 9 month | The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory. |
Countries
Japan
Participant flow
Recruitment details
In this study the first patient was enrolled in June 2011 and the last patient was enrolled in January 2012 in eleven hospitals in Japan.
Pre-assignment details
There was no significant episode for screening processes.
Participants by arm
| Arm | Count |
|---|---|
| Stent Placement Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.
MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Stent Placement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 69.4 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Japan | 65 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 65 |
| serious Total, serious adverse events | 16 / 65 |
Outcome results
Primary
Target Lesion Failure(TLF)
Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)
Time frame: 9 month
Population: All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stent Placement | Target Lesion Failure(TLF) | 4.62 percentage of TLF |
Secondary
Binary Angiographic Restenosis
Defined as =\> 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.
Time frame: Baseline and 9 month
Population: 67 lesions in 65 patients were analysed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stent Placement | Binary Angiographic Restenosis | 1.5 percentage of patient |
Secondary
Clinical Endpoints
Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis
Time frame: 5 Years
Secondary
Late Lumen Loss
Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.
Time frame: Baseline and 9 months
Population: 67 Lesions in 65 patients are analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stent Placement | Late Lumen Loss | 0.27 mm | Standard Deviation 0.33 |
Secondary
MACE (Major Adverse Cardiac Event)
Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.
Time frame: Baseline and 9 month
Population: 65 patients were analyzed as ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stent Placement | MACE (Major Adverse Cardiac Event) | 2 percentage of patient |
Secondary
Minimum Luminal Diameter
The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.
Time frame: 9 month
Population: 67 lesions in 65 patient were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stent Placement | Minimum Luminal Diameter | 1.86 mm | Standard Deviation 0.39 |
Secondary
Percent Diameter Stenosis
The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).
Time frame: Baseline and 9 month
Population: 67 lesions in 65 patients were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stent Placement | Percent Diameter Stenosis | 12.92 % DS (diameter stenosis) | Standard Deviation 14.63 |