A Prospective, Multicenter, Sponsor Initiated, Randomized Controlled Trials to Evaluate the Safety and Efficacy of Genoss® DCB Compared to Sequent® Please in Korean Patients With Coronary Artery In-stent Restenosis (ISR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- In-segment late lumen loss after percutaneous coronary intervention in patients with ISR
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please)
详细描述
In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.
Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years old
- •Patients with significant coronary artery stenosis including left main coronary lesion (> 50% diameter stenosis on coronary angiography)
- •Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
- •Patients suitable to receive coronary revascularization of any type
- •Restenosis Mehran type I-III after stent implantation for the first time
- •Patients with In-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to Mehran type I-Ⅲ.
- •Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the stenosis lesion should be no more than 40mm
- •In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form
排除标准
- •Patients with Infarct related artery (IRA) lesions among patients with acute myocardial infarction
- •Patients have restenosis lesions with thrombosis
- •Patients with a history of cardiogenic shock
- •Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
- •Patients with graft vessel lesion
- •Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel
- •Patients with renal insufficiency (eGFR<30mL/min)
- •Pregnant or lactating women
- •The patients have a life expectancy of less than 12 months
- •Patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening
- •Patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study
- •Patients who are unsuitable for the study according to the investigator judges
结局指标
主要结局
In-segment late lumen loss after percutaneous coronary intervention in patients with ISR
时间窗: Follow-up angiography at 6 months after procedure
In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR
次要结局
未报告次要终点