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
干预措施
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).
研究组 & 干预措施
Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd.
Experimental
干预措施: Coronary artery sawtooth cutting balloon dilation catheter (Device)
Cutting Balloon Catheter
Active Comparator
干预措施: Cutting balloon catheter (Device)
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
相似试验
Unknown
不适用
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small VesselsCoronary Artery DiseaseNCT06345209BrosMed Medical Co., Ltd236
已完成
不适用
Wedge NC - Scoring Balloon Dilatation CatheterCoronary Artery DiseaseNCT06214247BrosMed Medical Co., Ltd198
尚未招募
不适用
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous FistulaPeripheral Arterial DiseaseNCT06029569Shanghai Bomaian Medical Technology Co., Ltd256
Unknown
不适用
The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) PatientSmall Vessel DiseaseNCT03625830B. Braun Medical International Trading Company Ltd.270
招募中
不适用
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower ExtremityIschemiaAtherosclerosisNCT05158257Xuanwu Hospital, Beijing144