[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"foramen-ovale-patent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:foramen-ovale-patent":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100388580","noblestitch-el-stitch-trial-is-a-pfo-comparative-trial-100388580",false,"NCT04339699","NobleStitch EL STITCH Trial is a PFO Comparative Trial","STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke","STITCH","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female ages 18 - 60 years old\n* A PFO and a Cryptogenic Stroke verified by a neurologist\n* Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:\n\n  * Symptoms persisting ≥24 hours, or\n  * Symptoms persisting \\\u003C24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct\n* Cryptogenic stroke was defined as a stroke of unknown cause\n* Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)\n* Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).\n* Hypercoagulable state assessment to rule out an underlying hypercoagulable state\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning a pregnancy during the course of the study\n* Age \\\u003C18 or \\> 60 years of age\n* Previous myocardial infarction or unstable angina within 6 months\n* Clinically significant mitral or aortic valve stenosis or severe regurgitation\n* Left Ventricular Ejection Fraction \\\u003C50 percent\n* Progressive neurological dysfunction or reduced life expectancy\n* Contrast allergy\n* Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases\n* Active Endocarditis\n* Perspective participants with known causes of Ischemic Stroke\n* Arterial dissection\n* Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants\n* Perspective participants with prosthetic heart valves\n* Uncontrolled diabetes Mellitus\n* Pulmonary hypertension\n* Uncontrolled systemic hypertension\n* Intracranial pathology\n* Neurological deficits not due to stroke that may affect neurologic assessments\n* Active autoimmune disease\n* Active infection\n* Alcohol and\u002For drug abuse\n* A requirement for chronic anticoagulation therapy that cannot be discontinued\n* Anatomic features (inability to achieve vascular access)","ALL","18 Years","60 Years",{"count":21,"type":22},640,"ESTIMATED","INTERVENTIONAL",[25],"NA","STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.",[28,29],"Foramen Ovale, Patent","Stroke, Ischemic",[31,32],"Patent Foramen Ovale","Stroke","RECRUITING","2026-03-18",{"date":36,"type":37},"2026-03-23","ACTUAL",{"date":39,"type":37},"2021-01-01",{"date":41,"type":22},"2027-06-30",{"name":43,"class":44},"Nobles Medical Technologies II Inc","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":72,"locationsCount":4},"100616034","study-on-the-safety-and-effectiveness-of-a-biodegradable-patent-foramen-ovale-occluder-system-100616034","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.","65 Years",{"count":55,"type":22},258,[25],"To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)",[59,60,61,62,63,28,29,64],"Cardiovascular Diseases","Cardiovascular Abnormality","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Atrial","Stroke (CVA) or TIA","NOT_YET_RECRUITING","2025-12-09",{"date":68,"type":37},"2025-12-23",{"date":70,"type":22},"2025-12-30",{"date":41,"type":22},{"name":73,"class":74},"Shanghai Lingsi Medical Technology Co., Ltd.","OTHER"]