Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Inclusion Criteria: 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. Exclusion Criteria: 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.