Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 12:16 PM
Study NCT ID:
NCT03967158
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2019-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'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}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-27', '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 year', 'description': 'Procedural success rate is defined as \\< 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Xience Sierra', 'Drug Eluting Stent', 'Percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease', 'Coronary Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Xience Sierra coronary stent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 and more\n* Patient with Xience Sierra Everolimus eluting coronary stent\n* Written consent\n\nExclusion Criteria:\n\n* Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time\n* Life-expectancy less than 1 year\n* Cardiac shock'}, 'identificationModule': {'nctId': 'NCT03967158', 'acronym': 'IRIS Sierra', 'briefTitle': 'Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY', 'orgStudyIdInfo': {'id': 'AMCCV2019-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Consecutive percutaneous coronary intervention', 'interventionNames': ['Device: Xience Sierra stent']}], 'interventions': [{'name': 'Xience Sierra stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention with Xience Sierra stent', 'armGroupLabels': ['Consecutive percutaneous coronary intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A Medical Center', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Gangwon National Univ. Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gangneung', 'country': 'South Korea', 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Eunpyeong St. Mary'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': 'Suncheon', 'country': 'South Korea', 'facility': 'St.carollo Hospital', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, '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 Interventional Cardiology. Cardiovascular Center, Asan Medical Center. University of Ulsan, College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}