Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
试验速览
- 阶段
- 4 期
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Angiographic in-segment late loss
研究概览
简要总结
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic outcomes or not is unknown. Lacrosse® Non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements which are attached to proximal and distal balloon edges. NSE is developed to incise neointimal tissue and avoid balloon slippage without vitiating balloon derivability and crossability. We investigated angiographic and clinical outcomes following normal non-compliant balloon or NSE dilatation prior to DCB dilatation in ISR lesions.This study is a single blinded, multicenter, randomized trial. Total 200 patients with ISR are randomly assigned to treat with non-compliant balloon or NSE before DCB dilatation. Optical coherence tomographic (OCT) analysis are performed before pre-dilatation and after DCB dilatation Follow-up angiography analysis are planned at 8 months in all patients. Clinical follow-up is planned at 8 and 24 months.Primary endpoint is angiographic in-segment late loss at 8 months.
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 (Participant)
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
- 是
入选标准
- •patients with in-stent restenosis lesions who are planned to be treated with drug coating balloon
排除标准
- •ST elevation myocardial infarction
- •stent thrombosis
- •severe renal dysfunction (eGFR <30 ml/min) except dialysis
- •pregnancy
- •planned surgery within 3 months
- •shock vital
研究组 & 干预措施
Non-slip element balloon (NSE)
Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)
干预措施: Non-slip element balloon (NSE) (Device)
Balloon
Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)
干预措施: Balloon (Device)
结局指标
主要结局
Angiographic in-segment late loss
时间窗: 8 months
次要结局
- DCB length(within one day)
- the prevalence of balloon slipping(within one day)
- angiographic minimal lumen diameter(8 months)
- minimal lumen area (OCT analysis)(within one day)
- mean neointimal area (OCT analysis)(within one day)
- angiographic acute gain(within one day)
- Target vessel failure(8 months and 24 months)
- the prevalence of stent implantation(within one day)
研究者
Jiro Aoki
Associate Director, Division of Cardiology
Mitsui Memorial Hospital