Randomized Comparison Between Sirolimus-eluting and Everolimus-eluting Coronary Stents in Chronic Coronary Occlusions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 主要终点
- In-stent late lumen loss at 9-month angiographic follow-up
研究概览
简要总结
Chronic total coronary occlusions (CTO) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES) have demonstrated to significantly reduce the risk of restenosis and new revascularization procedures in comparison with bare-metal stents.
Most data on the efficacy of DES come from the sirolimus-eluting coronary stent Cypher (Cordis corp.), and paclitaxel-eluting coronary stent Taxus (Boston Sci.), and the Cypher stent is the only DES that has been randomly tested in CTO. Among second-generation DES, everolimus-eluting stent (EES) has shown excellent angiographic and clinical results, but this DES has not been studied in unfavourable scenario (such as CTO).
The aim of the CIBELES trial is to demonstrate the hypothesis that EES are equally effective in comparison with sirolimus-eluting stents in the treatment of CTO, in terms of angiographic efficacy considered as in-stent late lumen loss.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients ≥ 18 year-old.
- •A total occlusion (TIMI 0-1) with an estimated time of occlusion > 2 weeks.
- •Symptomatic or silent ischaemia, or viable myocardium.
- •The occlusion is suitable for percutaneous coronary intervention.
- •The guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.
排除标准
- •Acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
- •The lesion can not be crossed with the guidewire and balloon angioplasty.
- •The vessel has been previously treated percutaneously.
- •The lesion is not suitable for a 2.25-3.5 coronary stent implantation.
- •The patient is not willing to undergo an angiographic follow-up.
- •The patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
- •Pregnancy or absence of pregnancy test in women of childbearing age.
- •Chronic renal failure (creatinine plasmatic values > 3.0 mg/dl).
- •Plasmatic platelet count < 100.000 mm-3 or > 700.000 mm-
- •The patient has a severe non-cardiac disease that limits his/her life expectancy to < 1 year.
- •The patient is currently included in other randomized trial.
结局指标
主要结局
In-stent late lumen loss at 9-month angiographic follow-up
时间窗: 9 months
次要结局
- Angiographic: rate of binary angiographic restenosis, rate of vessel re-occlusion, and in-segment late loss, at 9 months(9 and 12 months)
- Clinical: death, myocardial infarction, new revascularization, and angina status at 1 year.(9 and 12 months)
研究者
Raul Moreno
Director of Invasive Cardiology, University Hospital La Paz, Madrid, Spain
Spanish Society of Cardiology