Comparison Among a Paclitaxel Eluting Stent With Biodegradable Polymer Versus an Uncoated Bare Metal Stent. A Prospective, Multicentric and Randomized Study.(EUCATAX Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Target Vessel Failure
研究概览
简要总结
The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).
For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.
详细描述
Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient signing informed consent after receiving extensive written and oral information about the trial,
- •Older than 18 years,
- •Agreement to have a control examination done after six months,
- •Patients with angina pectoris symptoms (CCS stages i-IV, unstable angina pectoris Braunwald B and C) and patients with documented silent ischemia;
- •Patients with one or more de novo lesions which all are to be dilated in the same session;
- •Target vessel diameter of 2.5 to 4.0 mm
排除标准
- •Female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases)
- •Acute myocardial infarction (Q wave or non Q wave ) with documented CK levels more than 2 fold higher than the normal values in the preceding 72 hours ,
- •Substantially calcified lesion precluding successful pre dilatation,
- •Ejection Fraction less than 35%,
- •Patient with previous PCI with one DES,
- •Target lesion < 2.5 mm
- •Coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia,
- •Allergy, hypersensitivity or adverse reaction to paclitaxel,
- •Intolerance to the clopidogrel, Ticlopidine or Aspirin or unable to receive clopidogrel for one year,
- •Active duodenal or gastric ulcer,
- •Life Expectancy less than 1 year,
- •Patient with LM disease (>50%)
结局指标
主要结局
Target Vessel Failure
时间窗: six months
次要结局
- Stent thrombosis(one year)
- Paclitaxel allergy(six months)
- Cost-effectiveness(one year)
- Quantitative Coronary Angiography(six months)