NCT06214754已完成不适用
A Prospective, Multicenter, Randomized Controlled Clinical Trial of the Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Device Procedural Success Rate
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.
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
- Single (Participant)
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
- •Be between 18 and 80 years of age (including boundary values) and have a life expectancy of more than 12 months；
- •Be able to understand the purpose of the study, voluntarily participate in and sign the informed consent, and be able and willing to accept the follow-up established in this study;
- •Ischemic cardiomyopathy with single or multiple coronary artery lesions and diagnostic evidence [e.g., stable angina, unstable angina, or occult ischemia (evidence of myocardial ischemia)；
- •Investigator is believed that the target atherosclerotic plaque needs to be incised and that predilation (if necessary) can enable the incised balloon to pass through the lesion；
- •The presence of coronary artery stenosis confirmed by imaging examination, suitable for percutaneous coronary intervention, coronary vessel stenosis ≥70%; Or ≥50% (visual) with evidence of ischemia, TIMI ≥ level 1；
- •The patient had autogenous coronary angiogenesis or restenosis, requiring stent treatment；
- •The reference vessel diameter of target lesion was 2.0mm-4.0mm, and the lesion length was ≤20mm；
- •When there are multiple lesions that need to be treated, only one in situ coronary lesion is selected as the target lesion, and the non-target lesion must be located on different vascular branches；
排除标准
- •Patients with bleeding tendencies, contraindications to antiplatelet and anticoagulant therapy, who are unable to undergo anticoagulant therapy；
- •Have had any myocardial infarction within a week；
- •People who have an allergic reaction to contrast media or can't take medication
- •There was severe renal failure with or without dialysis, glomerular filtration rate (eGFR) <30ml/min/1.73m2 or serum creatinine level >2.0 mg/ dl；
- •cardiogenic shock；
- •Patients who have received heart transplants；
- •Patients who are not eligible for coronary artery bypass surgery；
- •The patient had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery；
- •The patient had a stroke or transient ischemic attack within 2 months before surgery；
- •Patients in the pregnancy or lactation period；
- •Participants are currently participating in any other clinical trial within 1 month prior to the trial；
- •Patients deemed unsuitable for inclusion by other investigators；
- •Severe calcified lesions and twisted lesions or lesion sites > 45 degrees angled；
- •Lesions with significant endometrial tears
- •Unprotected left main lesion；
- •The contrast showed a blood clot；
- •Scaffold fracture lesion；
- •Distal stent lesion after stent implantation；
结局指标
主要结局
Device Procedural Success Rate
时间窗: immediately after PTCA
In the case of balloon dilatation and stenosis, balloon delivery, balloon filling and dilatation, balloon withdrawal pressure retraction and successful balloon retraction can be successfully completed. After balloon dilatation, residual stenosis of the target lesion is less than 50%
次要结局
- Clinical Success Rate(immediately after PCI)
研究者
研究点 (12)
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