Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT07300358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 258}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of effective occlusion', 'timeFrame': 'at 12 months post-implantation', 'description': 'Effective occlusion was defined as: 12 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.'}], 'secondaryOutcomes': [{'measure': 'Success rate of effective occlusion', 'timeFrame': 'at 6 months post-implantation', 'description': 'Effective occlusion was defined as: 6 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.'}, {'measure': 'Device Success Rate', 'timeFrame': 'immediately after the procedure', 'description': 'Successful intraoperative deployment of the occluder, with immediate post-procedure echocardiography confirming appropriate device morphology and position, absence of new pericardial effusion or valvular regurgitation, and successful retrieval of the delivery system'}, {'measure': 'Procedural success Rate', 'timeFrame': 'at discharge or 7 days post-procedure', 'description': 'Successful device implantation without any procedure- or device-related complications prior to discharge. Complications include atrial fibrillation, other serious arrhythmic events, thrombosis, cerebral embolism, pericardial effusion, cardiac tamponade, device embolization, or displacement'}, {'measure': 'Recurrence or incidence of cryptogenic stroke or TIA', 'timeFrame': 'From attempted procedure up to 12 months post-implantation', 'description': 'Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.'}, {'measure': 'All-cause mortality', 'timeFrame': 'From attempted procedure up to 12 months post-implantation', 'description': 'All-cause death is defined as death from any cause during the follow-up period'}, {'measure': 'Incidence of new atrial fibrillation and atrial flutter', 'timeFrame': 'From attempted procedure up to 12 months post-implantation', 'description': 'atrial fibrillation and atrial flutter'}, {'measure': 'Incidence of device-related serious adverse events', 'timeFrame': 'From attempted procedure up to 12 months post-implantation', 'description': 'including but not limited to: Device-related thrombosis、embolic stroke、peripheral arterial embolism、Ⅲ° atrioventricular block、cardiac erosion、infective endocarditis、severe hemolytic anemia'}, {'measure': 'Device defects', 'timeFrame': 'From attempted procedure up to 12 months post-implantation', 'description': 'Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures.'}, {'measure': 'Migraine Headache events', 'timeFrame': 'At 6 months and 12 months post-implantation', 'description': 'Change in the number of monthly migraine days from baseline to 6 months and 12 months.\n\nChange in the number of migraine attacks from baseline to 6 months and 12 months.\n\nChange in the Score of HIT-6 or VAS or MIDAS from baseline to 6 months and 12 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Cardiovascular Abnormality', 'Heart Defects, Congenital', 'Heart Septal Defects', 'Heart Septal Defects, Atrial', 'Foramen Ovale, Patent', 'Stroke, Ischemic', 'Stroke (CVA) or TIA']}, 'descriptionModule': {'briefSummary': 'To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)', 'detailedDescription': 'This is a prospective, multicenter, randomized, controlled, non-inferiority clinical study. The study aims to evaluate the safety and efficacy of a novel biodegradable patent foramen ovale (PFO) occluder system compared to a conventional metallic occluder in patients with a PFO that is clinically determined to be associated with an PFO⁃associated stroke（PFO-AS）or transient ischemic attack (TIA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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) \\< 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.'}, 'identificationModule': {'nctId': 'NCT07300358', 'acronym': 'BIOCLOSE-PFO', 'briefTitle': 'Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Lingsi Medical Technology Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ShanghaiLingsiMedTech'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cardi-o-fix PFO occluder', 'description': 'Participants treated with th with the Cardi-o-fix PFO occluder according to the INSTRUCTIONS for Use (IFU)', 'interventionNames': ['Device: Active Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Biodegradable PFO occluder system', 'description': 'Participants treated with th with the biodegradable PFO occluder system according to the INSTRUCTIONS for Use (IFU)', 'interventionNames': ['Device: Experimental']}], 'interventions': [{'name': 'Active Comparator', 'type': 'DEVICE', 'otherNames': ['Cardi-o-fix PFO occluder'], 'description': 'Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder', 'armGroupLabels': ['Cardi-o-fix PFO occluder']}, {'name': 'Experimental', 'type': 'DEVICE', 'description': 'Transcatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder', 'armGroupLabels': ['Biodegradable PFO occluder system']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'XiangBin Pan, Doctor', 'role': 'CONTACT', 'email': 'xiangbin428@hotmail.com', 'phone': '13811763898'}, {'name': 'Wenbin Ouyang, Doctor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'XiangBin Pan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Lingsi Medical Technology Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}