RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 190
- 试验地点
- 50
- 主要终点
- Minimal lumen diameter
研究概览
简要总结
Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.
详细描述
Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis.
This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 85 years
- •Signed informed consent
- •Acceptance of late angiographic control (6-9 months)
- •Angina and / or objective evidence of ischemia
- •In-Stent restenosis (> 50% visual) any bare metal stent
- •Knowledge of prior stent location
排除标准
- •Inclusion in another clinical research protocol
- •Women of childbearing age
- •Severe associated systemic disease (including renal or liver failure)
- •Severe depression of left ventricular ejection fraction (LVEF <25%)
- •Disease that affects life expectancy
- •Recent myocardial infarction ( <7 days)
- •Time of implantation of the previous BMS <1 month
- •Severe difficulties expected for late angiographic study
- •Angiographic failure during implementation of initial stent(residual stenosis> 50%)
- •Image of large thrombus in-stent (> vessel diameter)
- •Tortuosity or Ca + + with very severe difficulties during prior stent deployment
- •Vessel diameter <2 mm (visual estimate)
- •Restenosis only "outside" the stent (The edge of the stent is not affected)
- •Completely occlusive restenosis (100%, TIMI 0)
- •Very diffuse restenosis (> 30 mm length)
结局指标
主要结局
Minimal lumen diameter
时间窗: Late angiographic follow-up (6-9 months)
Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)
次要结局
- Combined clinical and angiographic end-points(6-9 months, 1 year and 3 years)
研究者
Fernando Alfonso, MD, PhD
Hospital Universitario Clínico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular