NCT06926400尚未招募不适用
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter for the Predilation of Coronary Artery Stenosis Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 182
- 主要终点
- Device Procedural Success Rate
研究概览
简要总结
To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.
详细描述
This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the 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
- •① The age is between 18 and 80 years old (including the boundary values), and the subjects are male or non-pregnant female.
- •Have single or multiple coronary artery lesions and diagnosed ischemic heart disease (for example: stable angina pectoris, unstable angina pectoris, old myocardial infarction or asymptomatic myocardial ischemia).
- •There are coronary artery stenosis lesions confirmed by coronary angiography, which are suitable for percutaneous coronary intervention. The coronary artery stenosis is ≥ 70% (by visual estimation); or ≥ 50% (by visual estimation) and accompanied by evidence of ischemia, and the TIMI blood flow is ≥ Grade
- •There are de novo or restenosis lesions in the coronary arteries of autologous or bypass graft vessels, and interventional treatment is required.
- •The visually estimated reference vessel diameter of the target lesion is 2.0mm - 4.0mm, and the lesion length is ≤ 20mm.
- •When there are multiple lesions that need to be treated, only one coronary artery lesion is selected as the target lesion, and the non-target lesions must be located on different vascular branches.
- •Be able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and be able to and willing to accept the follow-up as specified in this trial.
排除标准
- •General Exclusion Criteria
- •Patients with New York Heart Association (NYHA) Class IV heart failure.
- •Patients with contraindications to anti - platelet and anticoagulant therapy and are unable to receive anticoagulant treatment.
- •Patients who have had any myocardial infarction within one week.
- •Patients with an allergic reaction to contrast agents. ⑤ Patients with severe renal failure, with a serum creatinine level > 2.0 mg/dl (177 μmol/L).
- •Patients who have undergone heart transplantation.
- •Patients who have had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery.
- •⑧ Patients who have had a stroke or transient ischemic attack within 3 months before surgery.
- •Pregnant or lactating patients. ⑩ Patients who are currently participating in any other clinical trials. ⑪ Patients whom the investigator deems unsuitable for enrollment. Exclusion Criteria Related to the Target Lesion (Detected by Coronary Angiography)
- •Tortuous lesions or lesions with an angulation of ≥ 45 degrees at the lesion site.
- •Lesions at the ostium with a distance of ≤ 2 mm from the left main coronary artery.
- •Unprotected left main coronary artery lesions. ④ Coronary angiography shows the presence of thrombus. ⑤ Before using the test device or the control device, the target lesion has a dissection of Type C or higher.
- •Target lesions that require treatment with coronary atherectomy or special balloons (such as scored balloons, spiked balloons, shock - wave lithotripsy systems, and cutting balloons of other brands).
结局指标
主要结局
Device Procedural Success Rate
时间窗: one hour
次要结局
- Clinical treatment success rate(one hour)
- acute lumen gain,ALG(one hour)
- The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery(30 days)
- The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery(30 days)
- The incidence of major adverse cardiac events (MACE) within 30 days after surgery(30 days)
- Evaluation of Device Performance(one hour)
- The incidence rate of medical device-related complications(one hour)
- The incidence rate of device defects(one hour)
- The incidence rate of adverse events and serious adverse events(thirty days)
研究者
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