Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 4:55 AM
Study NCT ID:
NCT03190057
Status:
TERMINATED
Last Update Posted:
2025-09-30
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IRIS-BioFreedom Cohort in the IRIS-DES Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding issue', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'All cause death', 'timeFrame': '5 year'}, {'measure': 'Cardiac death', 'timeFrame': '5 year'}, {'measure': 'Myocardial Infarction', 'timeFrame': '5 year'}, {'measure': 'Composite event rate of death or myocardial infarction (MI)', 'timeFrame': '5 year'}, {'measure': 'Composite event rate of cardiac death or myocardial infarction (MI)', 'timeFrame': '5 year'}, {'measure': 'Target- Vessel Revascularization', 'timeFrame': '5 year'}, {'measure': 'Target- Lesion Revascularization', 'timeFrame': '5 year'}, {'measure': 'Stent thrombosis', 'timeFrame': '5 year'}, {'measure': 'Stroke', 'timeFrame': '5 year'}, {'measure': 'Procedural Success rate', 'timeFrame': '5 day', 'description': 'defined as achievement of a final diameter stenosis of \\<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BioFreedom', 'Drug Eluting Stent', 'Coronary Artery Disease'], 'conditions': ['Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effectiveness and safety of BIOFREEDOM™ FAMILY stent in the "real world" daily practice as compared with other drug-eluting stents.', 'detailedDescription': 'BIOFREEDOM™ FAMILY stent means that Biofreedom stent, Biofreedom Ultra and the other stents with names starting with Biofreedom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with BIOFREEDOM™ FAMILY stent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 and more\n* Patient with BIOFREEDOM™ FAMILY stent\n* Written consent\n\nExclusion Criteria:\n\n* Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time\n* Life-expectancy less than 1 year\n* Cardiac shock'}, 'identificationModule': {'nctId': 'NCT03190057', 'acronym': 'IRISBioFreedom', 'briefTitle': 'IRIS-BioFreedom Cohort in the IRIS-DES Registry', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'AMCCV2017-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Consecutive percutaneous coronary intervention', 'interventionNames': ['Device: BIOFREEDOM™ FAMILY stent']}], 'interventions': [{'name': 'BIOFREEDOM™ FAMILY stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent', 'armGroupLabels': ['Consecutive percutaneous coronary intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital, Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Daejeon ST. Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}