A Randomized Comparison of Recanalisation With Implantation of Cypher Sirolimus Eluting Coronary Stents and Medical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Changes from baseline in regional left ventricular function at 9 months
研究概览
简要总结
The study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the superiority of medical therapy over revascularisation.
详细描述
In the REVASC-study recovery of left ventricular function after recanalization of chronic total coronary occlusions (CTO) and implantation of sirolimus-eluting stents will be examined and compared to medical treatment. Extent of the scar, viable myocardium in the infarct zone and regional left ventricular function will be assessed by cardiac magnetic resonance. Patients with regional systolic left ventricular dysfunction of any degree in the supply territory of the CTO vessel will be randomized to either recanalization of the occluded coronary artery or to conservative therapy. It is of interest whether CTO patients will have an improvement in left ventricular function after late coronary reopening, regarding the high technical demands and costs of CTO recanalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
- •chronic total occlusion has more than 4 weeks duration
- •the target vessel has not previously been treated with percutaneous coronary intervention
- •the target vessel must be feasible for stent implantation
- •patient has stable or unstable angina pectoris or a positive functional study for ischemia
- •patient must be 18 years of age or older
- •female subjects of childbearing age must have a negative pregnancy test within 7 days before procedure
- •patient has been informed of the nature of the study and agrees to its
- •provisions ans has written informed consent as approved by the Ethics Committee
- •patient complies with all required post-procedure follow-up
排除标准
- •a documented left ventricular function < 30%
- •patient has a acute myocardial infarction (>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
- •patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
- •patient has a platelet count of < 100000 cells/mm3 or > 700000 cells/m3, a white blood cell count of < 3000 cells/mm3 or documented or suspected liver disease
- •patient has a history of bleeding diathesis or coagulopathy
- •patient has suffered a cerebrovascular accident or transient ischemic attack within the past 6 months
- •active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
- •patients has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years)
- •the target vessel contains intraluminal thrombus
- •the target vessel or lesson shows angiographic evidence of severe calcification
- •patient has contraindications to magnetic resonance imaging
结局指标
主要结局
Changes from baseline in regional left ventricular function at 9 months
时间窗: 9 months
Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.
次要结局
- Change from baseline in global left ventricular function at 6 months(6 months)
- Changes from baseline in left ventricular volume at 6 months(6 months)
研究者
Dr. Heinz Joachim Buettner
head of cath-lab department
University Heart Center Freiburg - Bad Krozingen