Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01348360
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2011-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of NOBORI Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2011-05-04', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)', 'timeFrame': '12 months post procedure'}], 'secondaryOutcomes': [{'measure': 'Death (all cause and cardiac)', 'timeFrame': 'one month'}, {'measure': 'Death (all cause and cardiac)', 'timeFrame': '6 months'}, {'measure': 'Death (all cause and cardiac)', 'timeFrame': 'yearly up to 5 years'}, {'measure': 'MI', 'timeFrame': 'one month'}, {'measure': 'MI', 'timeFrame': '6 months'}, {'measure': 'MI', 'timeFrame': 'yearly up to 5 years'}, {'measure': 'Composite of death or MI', 'timeFrame': 'one month'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': 'one month'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': '6 months'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': 'yearly and up to 5 years'}, {'measure': 'Composite of death or MI', 'timeFrame': '6 months'}, {'measure': 'Composite of death or MI', 'timeFrame': 'yearly up to 5 years'}, {'measure': 'TVR', 'timeFrame': 'one month'}, {'measure': 'TVR', 'timeFrame': '6 months'}, {'measure': 'TVR', 'timeFrame': 'yearly up to 5 years'}, {'measure': 'Target-lesion revascularization (TLR)', 'timeFrame': 'one month'}, {'measure': 'Target-lesion revascularization (TLR)', 'timeFrame': '6 months'}, {'measure': 'Target-lesion revascularization (TLR)', 'timeFrame': 'yearly up to 5 years'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': 'one month'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': '6 months'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': 'yearly up to 5 years'}, {'measure': 'Procedural success (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)', 'timeFrame': 'At discharge from the index hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effectiveness and safety of Nobori stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).', 'detailedDescription': 'This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of NOBORI stents versus first-generation DES in patients with coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease requiring drug eluting stents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving NOBORI stents.\n* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.\n\nExclusion Criteria:\n\n* Patients with a mixture of other DESs.\n* Terminal illness with life expectancy \\<1 year.\n* Patients with cardiogenic shock.'}, 'identificationModule': {'nctId': 'NCT01348360', 'acronym': 'IRIS-NOBORI', 'briefTitle': 'Evaluation of Effectiveness and Safety of NOBORI Stent', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'CVRF2010-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NOBORI stent'}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Republic of Korea', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Bucheon ST.Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Gangwon National Univ. Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Daejeon ST. Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeongju', 'country': 'South Korea', 'facility': 'DongGuk University Gyongju Hospital', 'geoPoint': {'lat': 35.84278, 'lon': 129.21167}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'National Health Insurance Corporation Ilsan Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Kwangju', 'country': 'South Korea', 'facility': 'Kwangju Christian Hospital', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KangBuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "St. Mary's Catholic Medical Center", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea St.Paul's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea Yeouido St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': "The Catholic University of Korea St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "The Catholic University of Korea Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Ki Bae Seung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital, Catholic University of Korea"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}, {'name': 'Terumo Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}