KCT0002895终止未知
Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease: Phase IV: Multicenter trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 888
研究概览
简要总结
Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Age 18 years of older
- •Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG.
- •Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- •Geographically accessible and willing to come in for required study visits
- •Signed informed consent.
排除标准
- •1. The patient has a known hypersensitivity or contraindication to any of the following medications:
- •· Heparin
- •· Aspirin
- •· Both Clopidogrel and TIclopidine
- •· Sirolimus, paclitaxel, ABT 578
- •· Stainless steel and/or
- •· Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- •2. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment. The deree of left ventricular ejection fraction is not considered as an index of exclusion.
- •3. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- •4. Prior CABG surgery
- •5. Prior PCI with DES implantation within 1 year
- •6. Two or more chronic total occlusions in major coronary territories
- •7. Acute ST-elevation MI(Q-wave) within 72 hours prior to enrollment requiring revascularization.
- •8. Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization. When the cardiac enzyme is returned to normal, those can be enrolled.
- •9. Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement.
- •10. Dementia with MMSE score 20 and less.
- •11. Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
- •12. Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- •13. Contraindication either CABG or PCI/DES because of a coexisting clinical condition
- •14. Severe leukopenia, monocytopenia, thrombocytopenia, anemia, bleeding tendency.
- •15. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- •16. Suspected pregnancy.
- •17. Concurrent enrollment in another clinical trial
- •18. Left main stenosis (at least 50% diameter stenosis)
研究者
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