Coronary Artery Disease
Conditions
Brief summary
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary arteries with reference vessels ≥ 2.25 mm to ≤ 2.75 mm.
Interventions
DEVICEEndeavor 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 INCLUSION CRITERIA: * The patient is ≥18 years of age. * The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or positive functional study. * The patient is an acceptable candidate for Percutaneous Transluminal Coronary Angiography (PTCA), stenting, and emergent Coronary Artery Bypass Grafting (CABG) surgery. * Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure. * The patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site. * The patient agrees to return to same research facility for all required post-procedure follow-up visits. ANGIOGRAPHIC INCLUSION CRITERIA 1\. The target lesion/vessel must meet the following criteria: 1. The patient requires treatment of either: * A single de novo lesion located in a native coronary artery amenable to treatment with a 2.25mm, 2.5mm or 2.75mm stent, or * Two de novo lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25mm, 2.5mm, or 2.75mm stent and the second lesion amenable to treatment with a 2.25mm, 2.5mm, or 2.75mm stent or a 3.0mm or 3.5mm approved Endeavor stent. 2. The lesion(s) must be ≤ 27mm in length. 3. The lesion(s) must have a stenosis of ≥ 50% and \< 100%. 4. The vessel(s) has (have) a thrombolysis in myocardial infarction (TIMI) flow 2 or greater. 5. The target vessel reference diameter must be ≥ 2.25mm and ≤ 2.75mm and the second target vessel reference diameter, if present, must be ≥ 2.25mm and ≤ 3.5mm. 6. All target lesions can be treated with a Medtronic Endeavor stent. GENERAL
Exclusion criteria
1. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or sensitivity to contrast media, which cannot be adequately pre-medicated 2. History of allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative 3. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or white blood cell count \<3,000 cells/mm³ 4. Serum creatinine level \>2.0 mg/dl within 7 days prior to index procedure 5. Evidence of acute MI within 72 hours of intended index procedure 6. Planned PCI of any vessel within 30 days pre or post-index procedure and/or planned PCI of the target vessel(s) within 12 months post-procedure. 7. During the index procedure, the target lesion(s) requires treatment with a device other than PTCA prior to stent placement 8. History of stroke or transient ischemic attack (TIA) within prior 6 months 9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months. 10. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusions. 11. Concurrent medical condition with life expectancy of less than 12 months. 12. Any previous or planned treatment of target vessel with anti-restenotic therapies including but not limited to brachytherapy. 13. Currently participating in an investigational drug or another device study that has not completed primary endpoint or that clinically interferes with current study endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures. 14. Documented left ventricular ejection fraction (LVEF) \<30% at most recent evaluation. 15. Inability to comply with protocol required medication regimen ANGIOGRAPHIC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment Percent Diameter Stenosis at 8 Months Post-procedure | 8 months post-procedure | In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA). |
| Major Adverse Cardiac Events (MACE) Rate | 12 months post-procedure | Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by local and regional medical centers from December 21, 2007 through November 22, 2010.
Pre-assignment details
Subjects were excluded from participation if they did not meet inclusion/exclusion criteria and fall into the category of per protocol small vessel stenting - 2.25mm, 2.5mm and 2.75mm - single or multi-vessel (Rev K).
Participants by arm
| Arm | Count |
|---|---|
| Endeavor Zotarolimus-Eluting Coronary Stent Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach | 241 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Endeavor Zotarolimus-Eluting Coronary Stent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 231 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 241 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 176 |
| serious Total, serious adverse events | 87 / 176 |
Outcome results
Primary
In-segment Percent Diameter Stenosis at 8 Months Post-procedure
In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).
Time frame: 8 months post-procedure
Population: The primary analysis sample consisted of 176 subjects (ITT) including the first 97 subjects with 2.25 mm, 39 subjects with 2.50 mm and 40 subjects with 2.75mm stents who met the study entry criteria, signed the written informed consent, and were enrolled in the trial.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Effectiveness Analysis Endpoint - SVS | In-segment Percent Diameter Stenosis at 8 Months Post-procedure | 37.4 percent diameter stenosis |
Comparison: The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.p-value: <0.001t-test, 2 sided
Primary
Major Adverse Cardiac Events (MACE) Rate
Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.
Time frame: 12 months post-procedure
Population: 12-month MACE Rate was compared to a 20% performance goal.~* 1st 97 subjects enrolled and implanted with 2.25mm stents~* 1st 39 subjects enrolled and implanted with 2.5mm stents~* 1st 40 subjects enrolled and implanted with 2.75mm stents~* A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Effectiveness Analysis Endpoint - SVS | Major Adverse Cardiac Events (MACE) Rate | 10.0 Percentage |
Comparison: The null and alternative hypotheses of interest are:~H0: xSVS \>= 20% vs. H1: xSVS \< 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%.p-value: 0.0041t-test, 1 sided