NCT05406869Unknown不适用
A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater in the Treatment of Coronary Calcified Lesions
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 170
- 试验地点
- 14
- 主要终点
- Procedural success rate
研究概览
简要总结
The prospective, multicenter, single- arm study is designed to verify the safety and efficacy of pulsed sonic balloon dilatation catheter and pulsed sonic generater in the treatment of coronary calcification lesions.
详细描述
The study will include a total of 170 patients with calcified coronary lesions who will be treated with pulsed sonic balloon dilatation catheter and pulsed sonic generater. Optical coherence tomography (OCT) imaging subgroups of 30 patients were designed in 1-2 centers to further accurately assess the treatment effect of calcified lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18≤age≤80 years old, males or females;
- •Life expectancy ≥ 6 months;
- •Patients with evidence of asymptomatic myocardial ischemia, stability or instability; with angina, or obsolete heart infarction for interventional therapy;
- •The target lesion is primary, in situ coronary artery lesion;
- •The target vessel reference diameter is 1.5-4.0mm, and the lesion length is ≤40mm (visual inspection);
- •Target lesion is with a visually estimated stenosis of ≥70%(or≥50% with evidence of myocardial ischemia) ;
- •Highly calcified lesions;
- •Only one target lesion requiring sonic balloon treatment is allowed;
- •The number of non-target lesions requiring interventional treatment is no more than 2, and the target lesions should be treated after the non-target lesions are successfully treated;
- •Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and can accept required clinical follow-up.
排除标准
- •New York Heart Association (NYHA) class III or IV;
- •Severe liver and kidney damage, transaminase more than 3 times the upper limit of normal, creatinine > 2.5mg/dL (221μmol/L) or chronic renal failure requiring long-term dialysis;
- •Stroke occurred within 6 months of joining the group, excluding transient is chemic attack (TIA) and cavity infarction;
- •Have a history of active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months of joining the group;
- •Platelet count <80×10⁹/L;
- •Subject refuses or is not suitable for CABG surgery;
- •The target lesion is planned to undergo coronary atherectomy, laser, double guide wire balloon, mastoid balloon, cutting balloon or thrombus aspiration;
- •Dissection of the target vessel after preoperative angiography or guide wire pass through;
- •The stent has been implanted within 10mm of the proximal or distal end of the target lesion, and there is a definite or possible thrombus in the target vessel;
- •The target lesion is located or involved within 5mm of the opening of LAD, LCX and RCA;
- •Left main stem disease or bridge vascular disease;
- •Angiography shows that the blood vessel path is tortuous, and the test device is difficult to reach the target position or difficult to recover;
- •Patients with implanted pacemakers or cardiac rhythm devices;
- •Evidence of aneurysm within 10 mm of the target lesion;
- •Patients who are known to be allergic to heparin, contrast agents, aspirin, clopidogrel, and anesthetics;
- •The subject is currently participating in another drug or device clinical study that has not yet completed;
- •Pregnant or nursing subjects;
- •Other patients should be excluded based on the assessment of the investigators;
结局指标
主要结局
Procedural success rate
时间窗: immediate post-procedure
Procedural success was defined as residual stenosis ≤30% after successful stent delivery without the occurrence of in-hospital adverse cardiac events (include cardiac death, target vessel-related myocardial infarction (TV-MI) and target lesion revascularizition)
次要结局
- Device success rate(immediate post-procedure)
- Target Lesion Failure (TLF)(before discharge or 7 days post-procedure, 30 days post-procedure)
- Ease of use of pulsed acoustic energy generators(immediate post-procedure)
- Lumen diameter obtained(immediate post sonic balloon treatment, immediate post-procedure)
- Percentage of diameter stenosis(immediate post sonic balloon treatment, immediate post-procedure)
- Patient-related cardiovascular clinical composite endpoint (POCE)(before discharge or 7 days post-procedure, 30 days post-procedure)
- The stability of the pulse sonic energy generator(immediate post-procedure)
- Confirmed and probable thrombotic events(before discharge or 7 days post-procedure, 30 days post-procedure)
研究者
研究点 (14)
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