Evaluation of the clinical performance of the Medtronic Endeavor ABT-578 eluting coronary stent system in patients undrgoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction

Medtronic Ltd (UK)0 个研究点目标入组 100 人开始时间: 2010年4月23日最近更新: 2015年1月13日

适应症

试验速览

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•1. The patient is greater than 18 years, either sex
•2. The patient has consented to participate by signing the Patient Informed Consent Form and/or has authorised the collection and release of his medical information by signing the patient Data release Consent form
•3. The patient has presented with 12 hours of onset symptoms, and the clinical decision has been made to undergo primary PCI
•4. Patient was suitable for implantation of one or more of the Endeavor ABT-578 Eluting Coronary Stent System, in one or more native artery target lesions
•5. Lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use that comes with every Endeavor ABT -578 Eluting Coronary Stent System
•6. The patient is willing and able to cooperate with the registry procedures and required telephone contacts

•1. Women with known pregnancy or who are lactating
•2. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacroloimus, sirolimus or similar drugs or any analogue or dervative, cobalt, chromium, nickel, molybdenum or contrast media
•3. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
•4. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon
•5. Current medical condition with a life expectancy of less than 12 months
•6. 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 enrolment in this trial. The subject may only be enrolled in this registry once.
•7. Patients with medical conditions that preclude the follow up as defined in the protocol or that otherwise limits participation in this registry
•8. Patients who are haemodynamically unstable (cardiogenic shock)
•9. Patients who have a myocardial infarction in a non native coronary artery

发起方

Medtronic Ltd (UK)