NCT05774288招募中不适用
A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 14
- 主要终点
- Success rate of effective occlusion
研究概览
简要总结
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
详细描述
The purpose of this prospective, multi-center, randomized, controlled non-inferiority clinical trial was to evaluate the safety and efficacy of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD for the treatment of cryptogenic stroke complicated with patent foramen ovale. The study required the implant to follow instructions strictly.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years;
- •Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
- •Patent foramen ovale was confirmed by at least one of the following conditions exists:
- •Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);
- •The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);
- •It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:
- •Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;
- •Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;
- •Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
- •Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.
排除标准
- •Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%);
- •Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score <6 points or infarction volume ≥70 ml or infarction area > 1/3 middle cerebral artery blood supply area);
- •Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
- •Acute myocardial infarction or unstable angina within 6 months;
- •Left ventricular aneurysm formation or left ventricular wall movement disorder;
- •Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;
- •Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure;
- •Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
- •Atrial fibrillation/atrial flutter (chronic or intermittent);
- •Pregnant or planning to become pregnant during the trial;
- •Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
- •Pulmonary hypertension or patent foramen ovale was a special channel;
- •Liver and kidney function impairment (ALT or AST > 3 times the upper limit of normal value, serum creatinine (Cr) > 2 times the upper limit of normal value);
- •Uncontrolled hypertension (> 180/100 mmHg);
- •Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
- •Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
- •The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;
- •Thrombosis exists at the location or route of implantation;
- •Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
- •Patients who could not be followed up during the trial;
- •Participate in clinical trials of other drugs or medical devices within three months.
结局指标
主要结局
Success rate of effective occlusion
时间窗: 180 days after surgery
Effective occlusion was defined as: 180 days after the surgery, Transthoracic echocardiography (TTE) showed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast transthoracic echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.
次要结局
- Success rate of occluder implantation technology(7 days after surgery)
- Success rate of complete occlusion(180 days after surgery)
- Success rate of effective occlusion(360 days after surgery)
- All-cause mortality rate(360 days, 2 years, 3 years, 4 years, 5 years after surgery)
- Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)(360 days, 2 years, 3 years, 4 years, 5 years after surgery)
- Success rate of surgical implantation of occlusion(7 days after surgery)
- Recurrence or incidence of cryptogenic stroke during follow-up(360 days, 2 years, 3 years, 4 years, 5 years after surgery)
- Incidence of new atrial fibrillation and atrial flutter during follow-up period(360 days, 2 years, 3 years, 4 years, 5 years after surgery)
- Incidence of device defects.(360 days, 2 years, 3 years, 4 years, 5 years after surgery)
研究者
研究点 (14)
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