Patent foramen ovale (PFO) related stroke or transient ischemic attack (TIA)
Conditions
Interventions
Test group:ConBrella biodegradable occluder systems ( Carefree Heartbeat Medical Technology (Shenzhen) Co., Ltd.)
Sponsors
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Age 18-65 years including,regardless of gender; (2) PFO on echocardiography examination (TEE or TTE) or right-to-left shunt confirmed by contrast-enhanced ultrasonography; (3) at least one of the following clinical conditions: A) stroke of unknown cause (CS) or transient cerebral ischemia (Tia) complicated with PFO with moderate to large amount of RLS, B) stroke of unknown cause (CS) or transient cerebral ischemia (Tia) complicated with PFO with recurrence after antiplatelet or anticoagulant therapy, C) stroke of unknown cause (CS) or transient cerebral ischemia (Tia) complicated with PFO with definite deep vein thrombosis, thrombosis (DVT) or pulmonary embolism (PE) , D) intractable or chronic migraine complicated with PFO in patients with refractory migraine who fail to benefit from conventional medical therapy, microemboli * or ischemic or aura migraine detected by cranial magnetic resonance imaging. (* Microemboli: local cerebral hypoperfusion caused by microthrombi.) (4) voluntary participation in this clinical trial Y and signed the informed consent of the subjects.
Exclusion criteria
Exclusion criteria: (1) any cause of cerebral embolism can be found; (2) contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial hemorrhage, obvious intracranial disease; (3) thrombosis of inferior vena cava or pelvic vein leading to complete obstruction; (4) systemic or local infection, septicemia, (5) intracardiac thrombosis; (6) pulmonary hypertension or PFO as a special channel, (20 mmhg) , complex congenital heart defects; (7) massive cerebral infarction within 4 weeks; (8) tantalum (nickel) allergy; (9) right to left shunt due to other causes, including atrial septal defect or pulmonary arteriovenous fistula; (10) pregnant or lactating women and those planning pregnancy during the trial; (11) malignant tumors or other diseases with a life expectancy of less than 2 years; (12) participating in clinical trials of other drugs or medical devices within 3 months; (13) the investigators judged that PFO occluder implantation was not appropriate, or there were other conditions that the investigators considered unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plugging success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Surgical success rate;Safety index; | — |
Countries
China
Contacts
Public ContactXiangbin Pan
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed