Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-26 @ 5:37 PM
Study NCT ID:
NCT03151018
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], '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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '12 months', 'description': 'Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Stent thrombosis, acute', 'timeFrame': 'within 24 hours after index PCI', 'description': 'according to Academic Research Consortium (ARC) definition'}, {'measure': 'Stent thrombosis, subacute', 'timeFrame': 'from 24 hours to 30 days after index PCI', 'description': 'according to ARC definition'}, {'measure': 'Stent thrombosis, late', 'timeFrame': 'from 30 days to 1 year after index PCI', 'description': 'according to ARC definition'}, {'measure': 'Stent thrombosis, very-late', 'timeFrame': '1 year ~ up to 3 years', 'description': 'according to ARC definition'}, {'measure': 'Target vessel failure', 'timeFrame': '12 months', 'description': 'Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)'}, {'measure': 'Composite rate of cardiac death and myocardial infarction', 'timeFrame': '12 months, 3 years', 'description': 'as title'}, {'measure': 'Composite rate of all-cause death and any myocardial infarction', 'timeFrame': '12 months, 3 years', 'description': 'as title'}, {'measure': 'Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization', 'timeFrame': '12 months, 3 years', 'description': 'as title'}, {'measure': 'Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy', 'timeFrame': '12 months, 3 years', 'description': 'we will estimate this outcome with relevant questionnaire'}, {'measure': 'Clinical device and procedural success rate', 'timeFrame': 'intraoperative ( index PCI)', 'description': 'device success : residual stenosis \\<30%, final thrombolysis in myocardial infarction (TIMI) flow grade III procedural success : device success + no adverse events immediate after the procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'percutaneous coronary intervention', 'zotarolimus-eluting stents'], 'conditions': ['Coronary Artery Disease', 'Acute Coronary Syndrome', 'Myocardial Infarction', 'Angina Pectoris']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are\n\n1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.\n2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.\n3. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.', 'detailedDescription': 'Secondary endpoints are\n\n1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention),\n2. Target vessel failure\n3. Composite rate of cardiac death and any MI, 3 years\n4. Composite rate of all death and any MI\n5. Composite rate of all death, any MI, and any repeat revascularization\n6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy\n7. Clinical device and procedural success'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 19\n* Patients who received PCI with Resolute Onyx™ stent(s)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03151018', 'acronym': 'HOST-ONYX', 'briefTitle': 'Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions - Registry-based Study on the Effect and Safety of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Onyx Registry', 'orgStudyIdInfo': {'id': 'HOST-ONYX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Onyx', 'description': 'The patients who received PCI with Resolute Onyx stent(s)', 'interventionNames': ['Device: Resolute Onyx']}], 'interventions': [{'name': 'Resolute Onyx', 'type': 'DEVICE', 'otherNames': ['Zotarolimus-eluting stent'], 'armGroupLabels': ['Onyx']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong Ho Heo', 'role': 'CONTACT'}], 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Kyo Jin, MD,PhD', 'role': 'CONTACT', 'email': 'bluesky@schch.co.kr'}, {'name': 'Dong-Kyu Jin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Deok-Kyu Cho', 'role': 'CONTACT'}], 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Uk Lee', 'role': 'CONTACT'}], 'facility': 'Gwangju Christian Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Kim, MD,PhD', 'role': 'CONTACT', 'email': 'mylovekw@hanmail.net'}, {'name': 'Won Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kwangju Veterans Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jang-Hwan Bae, MD,PhD', 'role': 'CONTACT', 'email': 'drcorazon@hanmail.net'}, {'name': 'Jang-Hwan Bae, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Je-Young Rhew, MD,PhD', 'role': 'CONTACT', 'email': 'jkrhew@hanafos.com'}, {'name': 'Je-Young Rhew, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jinju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Choong-Hwan Cwak, MD,PhD', 'role': 'CONTACT', 'email': 'cwakch@korea.com'}, {'name': 'Choong-Hwan Cwak, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Han-Cheol Lee, MD,PhD', 'role': 'CONTACT', 'email': 'glaraone@hanmail.net'}, {'name': 'Han-Cheol Lee, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Ju Choi, MD,PhD', 'role': 'CONTACT', 'email': 'djchoi@snu.ac.kr'}, {'name': 'Dong-Ju Choi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Ho Kang, MD,PhD', 'role': 'CONTACT', 'email': 'jinho2.kang@samsung.com'}, {'name': 'Jin-Ho Kang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyuk-Moon Kwon, MD,PhD', 'role': 'CONTACT', 'email': 'kwonhm@yuhs.ac'}, {'name': 'Hyuk-Moon Kwon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun-Cheol Kwon, MD,PhD', 'role': 'CONTACT', 'email': 'hcgwon@skku.edu'}, {'name': 'Hyun-Cheol Kwon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '82-2-2072-2226'}, {'name': 'Hyo-soo Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bon-Kwon Koo, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyun-Jae Kang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hae-Young Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyun-Jae Cho, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kyung-Woo Park, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Han-Mo Yang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jung-Kyu Han, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sang-Eun Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min-Soo Hyon, MD,PhD', 'role': 'CONTACT', 'email': 'mshyon@hosp.sch.ac.kr'}, {'name': 'Min-Soo Hyon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Geon-Woong Moon, MD,PhD', 'role': 'CONTACT', 'email': 'cardiomoon@gmail.com'}, {'name': 'Geon-Woong Moon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Hyo-soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '+82-2-2072-2226'}], 'overallOfficials': [{'name': 'Hyo-soo Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}