Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02593994
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2015-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IRIS-Onyx Cohort in the IRIS-DES Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-08', 'studyFirstSubmitDate': '2015-10-30', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent thrombosis', 'timeFrame': '1 year', 'description': 'As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis'}], 'secondaryOutcomes': [{'measure': 'All death', 'timeFrame': '5 year'}, {'measure': 'Cardiac death', 'timeFrame': '5 year'}, {'measure': 'Myocardial infarction', 'timeFrame': '5 year'}, {'measure': 'Composite event of death or myocardial infarction', 'timeFrame': '5 year'}, {'measure': 'Composite event of cardiac death or myocardial infarction', 'timeFrame': '5 year'}, {'measure': 'Composite event rate', 'timeFrame': '5 year', 'description': 'death, myocardial infarction, target vessel revascularization'}, {'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', 'timeFrame': '3 day', 'description': 'defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Onyx', 'drug eluting stent', 'Routine Clinical Practice', 'Angioplasty, Transluminal, Percutaneous Coronary', 'Coronary Artery Disease'], 'conditions': ['Coronary Artery Disease', 'Arterial Occlusive Diseases', 'Cardiovascular Diseases', 'Percutaneous Transluminal Angioplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with Onyx Drug Eluting Stent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 and more\n* Intervention with Onyx Drug Eluting Stent\n* Agreed with written informed consent form\n\nExclusion Criteria:\n\n* Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time\n* Life expectancy of 1year and under\n* Cardiac shock'}, 'identificationModule': {'nctId': 'NCT02593994', 'acronym': 'IRIS-Onyx', 'briefTitle': 'IRIS-Onyx Cohort in the IRIS-DES Registry', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Resolute Onyx™ and Onyx Frontier™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'AMCCV2015-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Onyx Drug Eluting Stent', 'interventionNames': ['Device: Onyx Drug Eluting Stent group']}], 'interventions': [{'name': 'Onyx Drug Eluting Stent group', 'type': 'DEVICE', 'armGroupLabels': ['Onyx Drug Eluting Stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Republic of Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-kyoung Sah, MD', 'role': 'CONTACT'}, {'name': 'Young-kyoung Sah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Catholic University of Korea, Yeouido St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'state': 'Songpa-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-jung Park, MD, PhD', 'role': 'CONTACT'}, {'name': 'Seung-jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Anyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun-Sook Kim, MD', 'role': 'CONTACT'}, {'name': 'Hyun-Sook Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Nae-Hee Lee, MD', 'role': 'CONTACT'}, {'name': 'Nae-Hee Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Cheonan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won-yong Shin, MD', 'role': 'CONTACT'}, {'name': 'Won-young Shin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong-Ki Lee, MD', 'role': 'CONTACT'}, {'name': 'Bong-Ki Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangwon National Univ. Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-bae Lee, MD', 'role': 'CONTACT'}, {'name': 'Jin-bae Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Ho Huh, MD', 'role': 'CONTACT'}, {'name': 'Seung-Ho Huh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In-whan Seong, MD', 'role': 'CONTACT'}, {'name': 'In-whan Seong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Daejeon ST. Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Sig Cheong, MD', 'role': 'CONTACT'}, {'name': 'Sang-Sig Cheong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myoung-Ho Jung, MD', 'role': 'CONTACT'}, {'name': 'Myoung-Ho Jung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Ilsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-wook Kwon, MD', 'role': 'CONTACT'}, {'name': 'Sung-wook Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Incheon', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-pil Park, MD', 'role': 'CONTACT'}, {'name': 'Jong-pil Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Kwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-uk Lee, MD', 'role': 'CONTACT'}, {'name': 'Seung-Uk Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kwangju Christian Hospital', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Moo-Hyun Kim, MD', 'role': 'CONTACT'}, {'name': 'Moo-Hyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dong-A Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae-Hyun Yang, MD', 'role': 'CONTACT'}, {'name': 'Tae-Hyun Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Gwang-soo Cha, MD', 'role': 'CONTACT'}, {'name': 'Gwang-soo Cha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': 'Bundang CHA Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyuck-Moon Kwon, MD', 'role': 'CONTACT'}, {'name': 'Hyuck-Moon Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-rae Cho, MD', 'role': 'CONTACT'}, {'name': 'Jung-rae Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-young Lee, MD', 'role': 'CONTACT'}, {'name': 'Jong-young Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyoo-rok Han, MD', 'role': 'CONTACT'}, {'name': 'Kyoo-rok Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-hyoung Park, MD', 'role': 'CONTACT'}, {'name': 'Jae-hyoung Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Cheol-ung Choi, MD', 'role': 'CONTACT'}, {'name': 'Cheol-ung Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hun-jun Park, MD', 'role': 'CONTACT'}, {'name': 'Hun-jun Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': "The Catholic University of Korea St. Paul's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jang-Hyun Cho, MD', 'role': 'CONTACT'}, {'name': 'Jang-Hyun Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St.carollo Hospital', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}, {'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-gon Lee, MD', 'role': 'CONTACT'}, {'name': 'Sang-gon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jang-young Kim, MD', 'role': 'CONTACT'}, {'name': 'Jang-young Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Yangsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun-hong Kim, MD', 'role': 'CONTACT'}, {'name': 'Jun-hong Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Seung-jung Park, MD, PhD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not a publicly funded trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}, {'name': 'Medtronic Korea Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}