E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent

Study Overview
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Brief Summary
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The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis. This prospective multi-center study has been initiated: To document the acute and mid-term safety and overall clinical performance of the stent system in a real world patient population requiring stent implantation. To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.

Official Title
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E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Endeavor Zotarolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is >18 years of age (or minimum age as required by local regulation) The patient has consented to participate by signing the Patient Informed Consent Form and/or has authorized the collection and release of his medical information by signing the Patient Data Release Consent Form. The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions. Lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use as mentioned in the Instructions for Use that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System. The patient is willing and able to cooperate with registry procedures and required follow up visits. Exclusion Criteria: Women with known pregnancy or who are lactating. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media. Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon. Current medical condition with a life expectancy of less than 12 months. The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endeavor Zotarolimus Eluting Coronary Stent|Drug eluting stent|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major Adverse Cardiac Events) | MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery)) | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Drug-eluting stent