NL-OMON39310已完成4 期
SECOND GENERATION DRUG ELUTING STENTS IMPLANTATION FOLLOWED BY SIX VERSUS TWELVE MONTH DUAL ANTIPLATELET THERAPY. - SECURITY
ONLUS0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria
- •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, according to the usual practice of the centre.
- •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
- •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 3 months before the target procedure
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 in the previous six months.
- •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 mmol/l)
- •10. Contraindication to the use of thienopyridines 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 receiving 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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