[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Lingsi Medical Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100616034","study-on-the-safety-and-effectiveness-of-a-biodegradable-patent-foramen-ovale-occluder-system-100616034",false,"NCT07300358","Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System","BIOCLOSE-PFO Study：Evaluation of the Safety and Efficacy of a Biodegradable Patent Foramen Ovale Occluder System: A Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Study","BIOCLOSE-PFO","Inclusion Criteria:\n\n* Aged between 18 and 65 years.\n* Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).\n* Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).\n* Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).\n\nExclusion Criteria:\n\n* An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.\n* Large territory cerebral infarction within 4 weeks prior to the planned procedure.\n* Atherosclerotic stenosis (\\>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.\n* Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.\n* Left ventricular ejection fraction (LVEF) \\\u003C 35%.\n* Atrial fibrillation or atrial flutter.\n* Left ventricular aneurysm or severe regional wall motion abnormality.\n* Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.\n* Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).\n* Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.\n* Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.\n* Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.\n* Acute myocardial infarction or unstable angina within 3 months prior to the procedure.\n* Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.\n* Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.\n* Concomitant cardiac anomalies requiring surgical correction.\n* Uncontrolled systemic or local infection, or sepsis.\n* Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).\n* Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).\n* Known hypersensitivity or allergy to tantalum or nickel.\n* Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.\n* Life expectancy less than 1 year due to malignancy or other comorbid disease.\n* Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.","ALL","18 Years","65 Years",{"count":21,"type":22},258,"ESTIMATED","INTERVENTIONAL",[25],"NA","To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)",[28,29,30,31,32,33,34,35],"Cardiovascular Diseases","Cardiovascular Abnormality","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Atrial","Foramen Ovale, Patent","Stroke, Ischemic","Stroke (CVA) or TIA","NOT_YET_RECRUITING","2025-12-09",{"date":39,"type":40},"2025-12-23","ACTUAL",{"date":42,"type":22},"2025-12-30",{"date":44,"type":22},"2027-06-30",{"name":46,"class":47},"Shanghai Lingsi Medical Technology Co., Ltd.","OTHER",""]