A Prospective, Multicenter, Randomized Controlled, Non-inferiority Design Clinical Trial, To Evaluate the Efficacy and Safety of the Coronary Artery Notched Balloon Dilation Catheter for the Pre-dilation of Coronary Artery Stenosis Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Rate of successful device usage
研究概览
简要总结
This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.
详细描述
This trial uses a prospective, multicenter, randomized controlled, non-inferiority comparison design. It is expected that the test group will be non-inferior to the control group in the main effectiveness evaluation index (device success rate). This trial plans to enroll 200 subjects who meet the requirements, and they will be randomly assigned to the test group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up for 30 days after percutaneous coronary intervention (PCI) treatment to compare the test group and the control group in the main effectiveness evaluation index (device success rate), secondary effectiveness evaluation indices (immediate lumen gain [QCA analysis], surgical success rate, in-hospital major adverse cardiac event [MACE] incidence rate, target lesion failure [TLF] incidence rate within 30 days after surgery, patient-related composite endpoints [PoCE] incidence rate during and within 30 days after surgery, device operation and performance evaluation), and safety evaluation indices (device-related complication incidence rate, adverse event/serious adverse event incidence rate, device defect incidence rate), in order to evaluate the effectiveness and safety of the coronary scoring balloon dilation catheter of the test medical device.
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
- •Voluntary participation in this trial and signed the informed consent form;
- •Age: ≥18 and ≤80 years old, regardless of gender;
- •The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.
排除标准
- •Acute myocardial infarction (AMI) within 7 days before surgery;
- •Serum creatinine level >2.0 mg/dL (177 umol/L) within 7 days before surgery;
- •Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery;
- •Stroke or transient ischemic attack (TIA) within 3 months before surgery;
- •Known left ventricular ejection fraction (LVEF) <30% (if LVEF is unknown, it can be measured during this surgery);
- •Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications;
- •Known subjects allergic to ingredients in the test product or contrast agent;
- •Known subjects who are pregnant or breastfeeding;
- •Planned to use coronary atherectomy, laser ablation, other scoring / spiked / cutting balloons (non-study devices) or shock wave balloons to treat the target lesion at the same time;
- •Subjects participating in other drug or device clinical studies;
- •Other situations that are not suitable for participation in this study as assessed by the investigator.
研究组 & 干预措施
Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）
Patients with Coronary Artery Disease will be treated with Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）
干预措施: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） (Device)
ScoreFlex NC Coronary Dilatation Catheter
Patients with Coronary Artery Disease will be treated with ScoreFlex NC Coronary Dilatation Catheter（OrbusNeich Medical [Netherlands] Ltd）
干预措施: ScoreFlex NC Coronary Dilatation Catheter (Device)
结局指标
主要结局
Rate of successful device usage
时间窗: 1hour
The investigational device was successfully delivered to the intended target lesion, dilated, deflated, and retrieved smoothly; After balloon angioplasty with the investigational device, the residual stenosis of the target lesion diameter was \<50%.
次要结局
- Rate of success of the surgery(3 days)
- Incidence of in-hospital MACE(30 days)
- The lumen is obtained immediately(1hour)
- Incidence of PoCE within 30 days after surgery(30 days)