Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01479218
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2011-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2011-11-18', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.', 'timeFrame': '30, 90, 180 and 360 days after implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patent Ductus Arteriosus']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a demonstrated patent ductus arteriosus\n2. Female or male\n3. Belonging to any ethnic group\n4. Age between \\> 6 months and 70 years\n5. Body weight \\> 6 kg \\< 120 kg\n\nExclusion Criteria:\n\n1. Associated congenital cardiac anomalies,\n2. Body weight \\< 6 Kilograms\n\nGeneral exclusion criteria\n\n* presence of a known coagulation disorder\n* thrombus at the position allocated for the implantation\n* a vein thrombosis in the blood vessels chosen for the introducing system\n* an active infection\n* Nitinol intolerance (nickel or titanium)\n* contrast medium intolerance\n* patients who have a vascular system which is too small to admit the required sheath\n* patients with pulmonary hypertension and pulmonary-vascular resistance of \\>8 Woods Units or a lung - / systemic resistance (PR/SR) of \\>0.4.'}, 'identificationModule': {'nctId': 'NCT01479218', 'briefTitle': 'Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Occlutech International AB'}, 'officialTitle': 'Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus', 'orgStudyIdInfo': {'id': 'Occlutech-PDA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PDA Occluder', 'description': 'single arm', 'interventionNames': ['Device: Occlutech PDA occluder']}], 'interventions': [{'name': 'Occlutech PDA occluder', 'type': 'DEVICE', 'description': 'Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.', 'armGroupLabels': ['PDA Occluder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'IJN National Heart Institute', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Hochiminh City', 'country': 'Vietnam', 'facility': 'Pediatric Hospital no 2'}], 'overallOfficials': [{'name': 'Ziyad M Hijazi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Rush University medical center, Chicago, USA'}, {'name': 'Alwi Mazeni, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IJN Heart Institute, Kuala Lumpur, Malaysia'}, {'name': 'Viet Minh Tri Nguyen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric hospital no 2, Hochiminh city, Vietnam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Occlutech International AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}