A Prospective, Multicenter, Non-inferior, Randomized Controlled Clinical Trial Comparing the Safety and Efficacy of Sequent ® Please Neo With Biolimus-released Coronary Balloon Catheter in the Treatment of Coronary Stent Restenosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- The late lumen loss
研究概览
简要总结
This study consisted of a randomized controlled trial group and a long balloon observation group.
In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 1:1 ratio; 30 consecutive subjects will be enrolled in the long balloon observation group, using graceful molimus release coronary balloon catheter with length of 45mm; All 310 subjects were followed up at baseline, surgery, discharge, 1 month after surgery, 6 months after surgery, 9 months after surgery, 1, 2 and 3 years after surgery, and angiography was performed at 9 months after surgery.
详细描述
This study consisted of a randomized controlled trial group and a long balloon observation group.
In the randomized control group, 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 1:1 ratio; 30 consecutive subjects will be enrolled in the long balloon observation group, using graceful molimus release coronary balloon catheter with length of 45mm; All 310 subjects were followed up at baseline, surgery, discharge, 1 month after surgery, 6 months after surgery, 9 months after surgery, 1, 2 and 3 years after surgery, and angiography was performed at 9 months after surgery.
The primary endpoint was late lumen loss at 9 months.
The study will enroll 310 subjects. The sample size determination process is as follows:
Randomized controlled trial group:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ subject age ≤80 years;
- •Stable angina pectoris, acute coronary syndrome, old myocardial infarction or proven asymptomatic myocardial ischemia;
- •Subjects have no contraindications to coronary revascularization (PCI or CABG); -
- •Subjects agreed to receive clinical follow-up at discharge, 1 month, 6 months, 9 months, 1 year, 2 years and 3 years after surgery, and angiographic follow-up at 9 months after surgery;
- •Subjects can understand the purpose of the study and have sufficient compliance with the study protocol. And willing to sign the informed consent and accept the risks and benefits stated in the informed consent.
排除标准
- •Patients with any myocardial infarction within 1 week, or patients whose myocardial enzyme CK or CK-MB has not returned to normal although myocardial infarction has occurred for more than 1 week;
- •Patients with severe congestive heart failure (NYHA IV) or severe valvular heart disease;
- •Female patients who are planning or are pregnant (or breastfeeding);
- •Patients with severe renal failure with creatinine >2.0 mg/dL (177 mol/L);
- •Left ventricular ejection fraction <30%;
- •Coagulation disorders, platelet count <100×109/ L;
- •Patients with cardiogenic shock;
- •Patients with concomitant diseases requiring cytoinhibitor or radiotherapy;
- •Patients who are known to be allergic to aspirin, clopidogrel, Gracilis, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel, or Ticagrelor;
- •Patients with bleeding constitution or a history of cerebral hemorrhage, active digestive ulcer, or gastrointestinal bleeding in the past 6 months will be restricted or prohibited to use anticoagulant therapy or anticoagulant drugs;
- •Patients with a life expectancy of less than 1 year or with underlying factors of difficult clinical follow-up;
- •Patients who are participating in any other clinical trial;
- •For other reasons, the researchers considered the patients unsuitable for inclusion.
结局指标
主要结局
The late lumen loss
时间窗: 9 months
Segmental late lumen loss of target lesions 9 months after surgery
次要结局
未报告次要终点