Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 6:27 PM
Study NCT ID:
NCT01350869
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2011-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)
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': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2011-04-22', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)', 'timeFrame': 'at 12 months after PCI', 'description': 'composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary.'}], 'secondaryOutcomes': [{'measure': 'All Death', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'Cardiac death', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'MI', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'Composite of death or MI', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'TVR', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'Target-lesion revascularization (TLR)', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': '1month ,6 month and 12 months,2year,3year,4 year and 5year', 'description': '1month ,6 month and 12 months,2year,3year,4 year and 5year'}, {'measure': 'Procedural success', 'timeFrame': 'at discharge', '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': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).', 'detailedDescription': 'This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients received XIENCE 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': 'NCT01350869', 'briefTitle': 'Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice', 'orgStudyIdInfo': {'id': '2009-0588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Xience stent', 'description': 'Real world patients treated with XIENCE stents', 'interventionNames': ['Device: Xience']}], 'interventions': [{'name': 'Xience', 'type': 'DEVICE', 'description': 'Patients with Xience', 'armGroupLabels': ['Xience stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-739', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}, {'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}