A Comparison Between Fractional Flow Reserve Guided and Coronary Angiography Guided Treatment Using Drug Eluting Balloon in In-stent Restenosis of Drug Eluting Stent: a Single-center, Prospective, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 主要终点
- target vessel failure
研究概览
简要总结
This is a prospective single center, randomized controlled clinical study aimed to compare the clinical and angiographic follow-up results of patients with in-stent restenosis(ISR) after coronary drug eluting stent(DES) implantation treated by fractional flow reserve -guided and angiography guided drug eluting balloon(DEB) intervention. This study intends to confirm the clinical benefits of optimizing DEB intervention of DES-ISR by FFR.
详细描述
420 patients with DES-ISR will be recruited in this study. After angiography, patients with DES-ISR to be treated with DEB will be randomly assigned to FFR-guided and angiography-guided groups. In FFR group, FFR at maximum hyperemia will be measured after pretreatment of DES-ISR lesion by balloons(non-compliant balloon, cutting balloon or scoring balloon). If FFR <0.9, the operator will dilate the DES-ISR lesion again before another FFR is measured. If FFR>=0.9, DEB will be used and final FFR will be measured at the end of the procedure. In angiography group, the operator will treat the DES-ISR lesion with balloons(non-compliant balloon, cutting balloon or scoring balloon), and then DEB without FFR guidance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-stent restenosis(ISR) occurred more than 6 months after drug eluting stent (DES) implantation
排除标准
- •ISR in bare metal stents and biodegradable stents
- •Complicated with immune diseases
- •ISR in left main DES
- •Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment
- •Severe cardiac insufficiency (LVEF <30%)
- •Subjects with ST segment elevation myocardial infarction within 7 days of onset of chest pain
- •Pregnant or lactating women
- •Combined with other diseases, life expectancy <1 year
- •Follow - up visits required by the protocol cannot be followed, or the investigators believe that the participation of subjects in the trial will increase the risk
结局指标
主要结局
target vessel failure
时间窗: 12 month
cardiac death, target vessel myocardial infarction, target vessel failure
次要结局
- angiographic outcomes(12 month)
- target vessel failure(36 month)