Inclusion Criteria:

1. The subject is aged between 18 and 65 years old;
2. Patent foramen ovale (PFO) confirmed by imaging examination with moderate or greater right-to-left shunt (RLS) (both condition a and b shall be satisfied simultaneously):a) Patent foramen ovale (PFO) confirmed by echocardiography (TTE or TEE);b) Moderate or greater right-to-left shunt confirmed by contrast echocardiography (cTTE, cTEE or cTCD);
3. Diagnosed as PFO-related stroke/TIA after clinical exclusion of other etiologies;
4. The subject or legal guardian understands the trial purpose, voluntarily participates in the trial, signs the written informed consent form, and is willing to complete follow-up in accordance with the protocol requirements.

Exclusion Criteria:

1. Carotid atherosclerotic stenosis (stenosis degree >50% confirmed by ultrasound or CTA);
2. Large cerebral infarction within 4 weeks (defined by imaging as hypodense area on CT involving more than 1/2 of the MCA perfusion territory, or infarct volume>145 ml on diffusion-weighted imaging (DWI));
3. Intracardiac thrombus or tumor, intracardiac vegetation;
4. Acute myocardial infarction or unstable angina within 6 months;
5. Presence of left ventricular aneurysm or left ventricular wall motion abnormality;
6. Severe valvular heart disease, such as severe mitral regurgitation or stenosis, severe aortic regurgitation or stenosis, mitral or aortic valve vegetation;
7. Combined cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, etc.);
8. Severe heart failure with LVEF <35%;
9. Pulmonary hypertension (mPAP >25 mmHg);
10. Right-to-left shunt caused by other etiologies, including atrial septal defect or pulmonary arteriovenous fistula;
11. Concomitant atrial fibrillation or atrial flutter;
12. Active endocarditis or other untreated infections;
13. Thrombosis in the access vessel or conditions interfering with the normal deployment of the study device;
14. Hepatic and renal dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of normal, or serum creatinine (Cr) >2 times the upper limit of normal);
15. Coagulopathy or contraindications to antiplatelet or anticoagulant therapy;
16. Pregnant or lactating females, or those planning pregnancy during the trial period;
17. The investigator judges that the PFO anatomy is unsuitable for occluder implantation or suture repair with the suture system, or has contraindications to PFO occlusion/suture treatment;
18. Malignant tumor or other diseases with life expectancy less than 1 year;
19. Participation in another clinical trial with trial endpoints not yet reached;
20. Other conditions deemed inappropriate for enrollment in this trial by the investigator.