A Prospective, Multicenter, Randomized Controlled Trials to Evaluate the Safety and Effectiveness of Genoss® DCB Versus SeQuent® Please NEO in Patients with Coronary In-stent Restenosis (ISR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- In-segment late lumen loss after procedure
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).
The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO.
In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.
详细描述
In a randomized controlled trials to compare with the same-category medical device (Sequent® Please NEO), 224 patients with in-stent restenosis (ISR) were recruited from a total of 13 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group(Genoss® DCB) and the control group(SeQuent® Please NEO), and each of the test or control devices was assigned to receive the procedure.
All patients were followed up 30 days, 6 months, 9 months, 1 year and 2 years after procedure, and angiographic follow-up was performed 9 months after procedure.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject related inclusion criteria
- •Age≥18 years old & ≤80 years old.
- •Patients with stable angina pectoris, unstable angina pectoris, stable acute myocardial infarction or confirmed silent myocardial ischemia.
- •Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
- •It is suitable for patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- •Desease related inclusion criteria
- •The target lesions were in stent restenosis: Mehran type I, II and III stenosis.
- •The stenosis rate of target lesion diameter was more than 70%, or more than 50%, accompanied by objective evidence of ischemia (such as stress electrocardiogram, myocardial perfusion imaging, FFR, etc.)
- •The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target lesion length was less than or equal to 26 mm.
- •It is expected that no more than two drug balloons will be used in each subject, and each target lesion can be covered by one drug balloon.
- •At most 2 primary lesions need interventional treatment, and the distance from the target lesion is more than or equal to 10 mm, and can be successfully treated before the intervention of the target lesion.
排除标准
- •Subject related exclusion criteria
- •A woman who is pregnant, lactating, or planning a pregnancy.
- •Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or history of cerebral hemorrhage, subarachnoid hemorrhage, active peptic ulcer and gastrointestinal bleeding within 3 months before operation.
- •Patients who are known to be allergic to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel or ticagrelor.
- •Patients with acute myocardial infarction within 1 week before operation.
- •Patients with Takayasu arteritis.
- •Left ventricular ejection fraction ≤ 30%.
- •Acute or chronic renal insufficiency (serum creatinine > 2.0mg/dl or 178 μ mol / L).
- •Patients with life expectancy less than 1 year.
- •Patients participating in clinical trials of other drugs or medical devices.
- •According to the researcher's judgment, the patient's clinical condition is not suitable for this study, or the patient is expected to be unable to complete the follow-up study according to the protocol.
- •Disease related exclusion criteria
- •The target lesion was total occlusion (Mehran type IV).
- •The target and non target lesions were left main artery lesions.
- •The target lesions were ostial, pontine and bifurcated lesions with branch diameter ≥ 2.5mm.
- •Three vessel disease requiring treatment.
- •More than 3 lesions (including target lesions and non target lesions) need to be treated in target vessels.
- •ISR lesions intervened within 6 months before operation.
- •Angiography confirmed thrombus in the target vessel.
- •The target vessel is severely calcified, tortuous and angulated, so it is expected that the drug balloon catheter will not pass successfully.
- •The lesions that could not be pre dilated successfully were grade C or above dissection after pre dilation, or residual stenosis > 30%, or TIMI blood flow < grade III.
结局指标
主要结局
In-segment late lumen loss after procedure
时间窗: at 9 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
- Device-oriented compoiste endpoint (DOCE)(at 30 days, 6 months, 9 months, 12 months and 24 months after procedure)
- Retenosis rate(at 9 months after procedure)
- Patient-oriented composite endpoint (POCE)(at 30 days, 6 months, 9 months, 12 months, and 24 months after procedure)
- Stent thrombosis by ARC definition(at 6 months, 9 months, 12 months, 24 months after procedure)