EUCTR2008-007526-19-IT进行中（未招募）不适用
Second Generation? Drug-Eluting Stents Implantation followed by Six versus Twelve-Month - Dual Antiplatelet Therapy - SECURITY
FONDAZIONE EVIDENCE0 个研究点目标入组 4,000 人开始时间: 2009年4月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent 2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug eluting stent 3. Patient is > 18 years of age (or minimum age as required by local regulations). 4. The patient has consented to participate by signing the ?Patient Informed Consent Form?. 5. The patient is willing and able to cooperate with study procedures and required follow up visits. 6. Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the exclusion criteria. 7. At least one second generation DES implanted in the target lesion in the last 24 hours. 8. No other DES implanted before the target procedure 9. No BMS implanted in the 12 months before the target procedure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients treated for lesions in venous or arterial grafts. 2. Patients treated for in-stent restenosis. 3. Patients treated for Unprotected Left Main lesions. 4. ST elevation myocardial infarction in the 48 hours prior to the procedure. 5. Non ST elevation myocardial infarction. 6. Patients with LVEF≤30%. 7. Women with known pregnancy or who are lactating. 8. Patients with hypersensitivity or allergies to heparin,, drugs such as ABT-578, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media. 9. Patients with chronic renal insufficiency (creatinine >2mg or mg or 180 mol/l) 10. Contraindication to the use of clopidogrel and/or ASA: a. History of drug allergy to thienopyridine derivatives or ASA; b. History of clinically significant or persistent thrombocytopenia or neutropenia 11. Active bleeding or significant risk of bleeding, such as elderly patients receining fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration., proliferative diabetic retinopathy. 12. Uncontrolled hypertension.. 13. Current medical condition with a life expectancy of less than 24 months. 14. 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. 15. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
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