Coronary Artery Disease
Conditions
Keywords
Restenosis
Brief summary
The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.5-3.5 mm.
Detailed description
The ENDEAVOR IV Trial is a prospective, multi-center, randomized, two-arm, single-blind trial that will enroll a total of 1,548 patients at up to 80 sites in the US. The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 2.5-3.5 mm.
Interventions
DEVICECoronary Artery Stenting
Endeavor Drug eluting stent
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study. * The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (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/Ethics Committee (IRB/EC) of the respective clinical site. * The patient agrees to return to the same research facility for all required post-procedure follow-up visits.
Exclusion criteria
* A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g., Phosphorylcholine or Translute), or a sensitivity to contrast media, which cannot be adequately pre-medicated. * History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative. * History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class. * A platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³. * A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure. * Evidence of an acute MI within 72 hours of the intended index procedure (defined as: QWMI or non-Q wave myocardial infarction (NQWMI) having CK enzymes \> 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal). * Previous PCI of the target vessel within 9 months pre-procedure. * Planned PCI of any vessel within 30 days post-procedure. * During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (including but not limited to, cutting balloon, any atherectomy, any laser, thrombectomy, etc.). * History of a stroke or transient ischemic attack (TIA) within the prior 6 months. * Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months. * History of bleeding diathesis or coagulopathy or will refuse blood transfusions. * Concurrent medical condition with a life expectancy of less than 12 months. * Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy. * Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures. * Documented left ventricular ejection fraction (LVEF) \< 30% at most recent evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure (TVF) rate | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Late lumen loss (in-segment late lumen loss is a powered secondary endpoint) | 9 months |
| Late loss index | 9 months |
| Angiographic binary restenosis (ABR) rate | 9 months |
| Minimum luminal diameter (MLD) | 9 months |
| Angiographic parameters (in-stent and in-segment) including: percent diameter stenosis (%DS) | 8 months |
| Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS) | 8 months |
| Target site revascularization (TSR) rate and clinically-driven TSR rate | 9 months |
| Target vessel revascularization (TVR) rate and clinically-driven TVR rate | 9 months |
| Major adverse cardiac event (MACE) rate | 30 days, 6, 9, and 12 months |
Countries
United States
Outcome results
None listed