OPtimal trEatment for coroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - The OPEN ISR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Occurrence of new onset target vessel myocardial infarction
研究概览
简要总结
The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).
These are the:
- Magic Touch - sirolimus coated balloon
- Emperor - paclitaxel and dextran coated balloon
- Xience - chromium-cobalt everolimus eluting stent
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
- None
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
- •Patients admitted for intervention of drug eluting stent restenosis
- •Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices
- •Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)
排除标准
- •Patients undergoing coronary angiography after sudden cardiac death
- •Pregnant or nursing
研究组 & 干预措施
Xience chromium-cobalt everolimus eluting stent
The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis.
干预措施: Intravascular management of prior implanted coronary drug eluting stent restenosis (Procedure)
Emperor paclitaxel coated balloon
The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
干预措施: Intravascular management of prior implanted coronary drug eluting stent restenosis (Procedure)
Magic Touch sirolimus coated balloon
The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
干预措施: Intravascular management of prior implanted coronary drug eluting stent restenosis (Procedure)
结局指标
主要结局
Occurrence of new onset target vessel myocardial infarction
时间窗: 6 months
New onset myocardial infarction that affects the target vessel treated with either study device
Occurrence of target vessel revascularization of failure
时间窗: 6 months
The need for further revascularization affecting the target vessel treated with either study device, or the failure of the vessel treated by either study device.
Occurrence of target lesion revascularization
时间窗: 6 months
The need for further revascularization of the target lesion after treatment with either study device.
次要结局
- Square millimeter intraluminal gain after treatment(6 months)
- Endothelium coverage in micrometers(6 months)
- Percentage late lumen loss(6 months)
- Percentage intraluminal gain after treatment(6 months)
- Square millimetre intraluminal gain after treatment(index procedure)
- Late lumen loss in square millimetres(6 months)
研究者
Istvan Edes
Associate Professor
Semmelweis University Heart and Vascular Center