NL-OMON33929已完成3 期
A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery Lesions - PLATINUM
Boston Scientific Cooperation International0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- •1. Patient must be at least 18 years of age.
- •2. Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C
- •3. Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment
- •4. No more than 2 de novo target lesions in 2 separate native epicardial vessels may be treated, as described below under Multiple Interventions During Index Procedure. Multiple focal lesions may be treated if the lesions can be completely covered with 1 stent.
- •5. No more than 1 de novo non-target lesion in 1 non-target vessel may be treated, as described below under Multiple Interventions During Index Procedure. Multiple focal lesions may be treated if the lesions can be completely covered with 1 stent.
- •6. Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) as follows:
- •o >=2.50 mm and <=4.25 mm for the RCT (WH selection criteria)
- •o >=2.25 mm and <2.50 mm for the non-randomized SV subtrial (SV selection criteria)
- •o >=2.50 mm and <=4.25 mm for the non-randomized LL subtrial (LL selection criteria)
- •7. Target lesion length must measure (by visual estimate):
- •o <=24 mm for the RCT (WH selection criteria)
- •o <=28 mm for the non-randomized SV subtrial (SV selection criteria)
- •o >24 mm and <=34 mm for the non-randomized LL subtrial (LL selection criteria)
- •8. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
排除标准
- •1. Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI.
- •2. Patient has had a known diagnosis of recent MI (ie, within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
- •o Patients are excluded if any of the following criteria are met at the time of the index procedure.
- •o If CK MB >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
- •o If CK MB is 1 2× ULN, the patient is excluded if the CK Total is >2× ULN.
- •o If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at the time of the index procedure.
- •o Troponin >1× ULN with at least one of the following.
- •o Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
- •o Development of pathological Q waves in the ECG; or
- •o Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- •3. Patient has received an organ transplant or is on a waiting list for an organ transplant.
- •4. Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
- •5. Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, etc.).
- •6. Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome.
- •7. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- •8. Patient has a white blood cell (WBC) count <3,000 cells/mm3.
- •9. Patient has documented or suspected liver disease, including laboratory evidence of hepatitis.
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