Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
研究概览
简要总结
In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.
详细描述
Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Indication of revascularization
- •De novo lesions
- •Native vessels
- •Suitable for stent placement
排除标准
- •Acute myocardial infarction within the last 24 hours
- •In stent restenosis
- •Previous percutaneous coronary intervention within the last 6 months
研究组 & 干预措施
A--Oral Rapamycin plus BMS
Oral sirolimus plus bare metal stent implantation
干预措施: Oral sirolimus (Drug)
B -- Drug Eluting Stent
Drug Eluting Stents
干预措施: Drug Eluting stent (Device)
结局指标
主要结局
Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
时间窗: Follow up will be conducted by the coordinating Center at 18 months of follow up
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
次要结局
- Major Adverse Cardiovascular Events (MACCE)(18 Months)
- Target Vessel Revascularization (TVR)(18 months)