Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01186120
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2010-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2010-08-18', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-segment late luminal loss', 'timeFrame': '9 month angiographic follow-up'}], 'secondaryOutcomes': [{'measure': 'Death (all-cause and cardiac)', 'timeFrame': '1 year'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'stent thrombosis(ARC criteria)', 'timeFrame': '1 year'}, {'measure': 'target-lesion revascularization', 'timeFrame': '1 year'}, {'measure': 'target-vessel revascularization', 'timeFrame': '1 year'}, {'measure': 'Procedural success', 'timeFrame': 'at 1 day'}, {'measure': 'Death (all-cause and cardiac)', 'timeFrame': 'one month'}, {'measure': 'Death (all-cause and cardiac)', 'timeFrame': '9 months'}, {'measure': 'Myocardial infarction', 'timeFrame': 'one month'}, {'measure': 'Myocardial infarction', 'timeFrame': '9 months'}, {'measure': 'Composite of death or MI', 'timeFrame': 'one month'}, {'measure': 'Composite of death or MI', 'timeFrame': '9 months'}, {'measure': 'Composite of death or MI', 'timeFrame': '1 year'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': 'one month'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': '9 months'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': '1 year'}, {'measure': 'target-lesion revascularization', 'timeFrame': 'one month'}, {'measure': 'target-lesion revascularization', 'timeFrame': '9 months'}, {'measure': 'target-vessel revascularization', 'timeFrame': 'one month'}, {'measure': 'target-vessel revascularization', 'timeFrame': '9 months'}, {'measure': 'stent thrombosis(ARC criteria)', 'timeFrame': 'one month'}, {'measure': 'stent thrombosis(ARC criteria)', 'timeFrame': '9 months'}, {'measure': 'In-stent late loss', 'timeFrame': '9 month angiographic follow-up'}, {'measure': '8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)', 'timeFrame': '12 months'}, {'measure': 'In-stent and in-segment restenosis', 'timeFrame': '9 month angiographic follow-up'}, {'measure': 'Angiographic pattern of restenosis', 'timeFrame': '9 month angiographic follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary disease', 'stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '36339368', 'type': 'DERIVED', 'citation': 'Kang DY, Jang JS, Chang M, Lee CH, Lee PH, Ahn JM, Lee SW, Kim YH, Park SW, Park DW, Park SJ; LONG-DES Investigators. Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions. JACC Asia. 2022 May 24;2(4):446-456. doi: 10.1016/j.jacasi.2022.02.009. eCollection 2022 Aug.'}, {'pmid': '24823426', 'type': 'DERIVED', 'citation': 'Lee JY, Park DW, Kim YH, Ahn JM, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Yang TH, Lee BK, Lee NH, Yang JY, Shin WY, Park HS, Kim KS, Hur SH, Lee SY, Park JS, Choi YS, Lee SU, Her SH, Park SJ. Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial. Circ Cardiovasc Interv. 2014 Jun;7(3):322-9. doi: 10.1161/CIRCINTERVENTIONS.113.000841. Epub 2014 May 13.'}]}, 'descriptionModule': {'briefSummary': 'This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.', 'detailedDescription': 'Following angiography, patients with significant diameter stenosis \\>50% and lesion length(\\> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must be at least 18 years of age.\n* Significant native coronary artery stenosis (\\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\\>=28mm)\n* Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction\n* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.\n\nExclusion Criteria:\n\n* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.\n* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.\n* Acute ST-segment-elevation MI or cardiogenic shock\n* Terminal illness with life expectancy \\<1 year\n* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.\n* In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted) Patients with EF\\<30%.\n* Serum creatinine level \\>=3.0mg/dL or dependence on dialysis.\n* Patients with left main stem stenosis (\\>50% by visual estimate).'}, 'identificationModule': {'nctId': 'NCT01186120', 'acronym': 'LONG-DES-V', 'briefTitle': 'Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents', 'orgStudyIdInfo': {'id': '2010-0036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biolimus A9-eluting stent', 'description': 'NOBORI stent', 'interventionNames': ['Device: Biolimus A9-eluting stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Everolimus-eluting stent', 'description': 'PROMUS ELEMENTE stent', 'interventionNames': ['Device: Everolimus-eluting stent']}], 'interventions': [{'name': 'Biolimus A9-eluting stent', 'type': 'DEVICE', 'otherNames': ['NOBORI stent'], 'description': 'drug-eluting stent', 'armGroupLabels': ['Biolimus A9-eluting stent']}, {'name': 'Everolimus-eluting stent', 'type': 'DEVICE', 'otherNames': ['PROMUS ELEMENT stent'], 'description': 'drug-eluting stent', 'armGroupLabels': ['Everolimus-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital, Buchen', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soonchunhyang University Cheonan Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Chooncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital'}, {'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': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'NHIC Ilsan Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A University Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University, Kangnam St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD.,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], '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'}}}}