RIBS IV (Restenosis Intra-stent of Drug-eluting 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
- 310
- 试验地点
- 50
- 主要终点
- Minimal lumen diameter
研究概览
简要总结
Treatment of patients with drug-eluting 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 drug-eluting stent restenosis.
详细描述
Treatment of patients with drug-eluting 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 drug-eluting 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 drug-eluting 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 drug-eluting 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 DES <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)
研究组 & 干预措施
Paclitaxel-eluting balloon
Paclitaxel-eluting balloon (SeQuent Please, B. Braun)
干预措施: Coronary angioplasty using the paclitaxel-eluting balloon (Device)
Everolimus-eluting stent
Everolimus-eluting stent (Xience Prime, Abbott Vascular)
干预措施: Coronary angioplasty using the Everolimus-eluting stent (Device)
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)