Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT01186094
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2009-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2009-10-18', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-segment late luminal loss', 'timeFrame': '9 month follow-up'}], 'secondaryOutcomes': [{'measure': 'All Death', 'timeFrame': '1 year'}, {'measure': 'Cardiac death', 'timeFrame': '1 year'}, {'measure': 'Myocardial infarction (MI)', 'timeFrame': '1 year'}, {'measure': 'Composite of death or MI', 'timeFrame': '1 year'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': '1 year'}, {'measure': 'Target vessel revascularization (ischemia-driven and clinically-driven)', 'timeFrame': '1 year'}, {'measure': 'Target lesion revascularization (ischemia-driven and clinically-driven)', 'timeFrame': '1 year'}, {'measure': 'Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)', 'timeFrame': '12 months'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': '1 year'}, {'measure': 'In-stent late loss at 9 month angiographic follow-up', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'In-stent and in-segment restenosis at 9 month angiographic follow-up', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'Angiographic pattern of restenosis at 9 month angiographic follow-up', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)', 'timeFrame': 'at 9 month angiographic follow-up'}, {'measure': 'Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay.', 'timeFrame': 'at 3 days in average', 'description': 'At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.)'}, {'measure': 'All death', 'timeFrame': 'one month'}, {'measure': 'All death', 'timeFrame': '9 months'}, {'measure': 'Cardiac death', 'timeFrame': 'one month'}, {'measure': 'Cardiac death', 'timeFrame': '9 months'}, {'measure': 'Myocardial infarction (MI)', 'timeFrame': 'one month'}, {'measure': 'Myocardial infarction (MI)', 'timeFrame': '9 months'}, {'measure': 'Composite of death or MI', 'timeFrame': 'one month'}, {'measure': 'Composite of death or MI', 'timeFrame': '9 months'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': 'one month'}, {'measure': 'Composite of cardiac death or MI', 'timeFrame': '9 months'}, {'measure': 'Target vessel revascularization (ischemia-driven and clinically-driven)', 'timeFrame': 'one month'}, {'measure': 'Target vessel revascularization (ischemia-driven and clinically-driven)', 'timeFrame': '9 months'}, {'measure': 'Target lesion revascularization (ischemia-driven and clinically-driven)', 'timeFrame': 'one month'}, {'measure': 'Target lesion revascularization (ischemia-driven and clinically-driven)', 'timeFrame': '9 months'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': 'one month'}, {'measure': 'Stent thrombosis (ARC criteria)', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23048051', 'type': 'DERIVED', 'citation': 'Ahn JM, Park DW, Kim YH, Song H, Cho YR, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Han S, Lee SY, Lee BK, Cho JH, Yang TH, Lee NH, Yang JY, Park JS, Shin WY, Kim MH, Bae JH, Kim MK, Yoon J, Park SJ. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012 Oct;5(5):633-40. doi: 10.1161/CIRCINTERVENTIONS.111.965673. Epub 2012 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation 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 IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE 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)\n* 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': 'NCT01186094', 'acronym': 'LONG-DES-IV', 'briefTitle': 'Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-eluting Stent', 'orgStudyIdInfo': {'id': '2008-0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cypher', 'description': 'Sirolimus-eluting stent', 'interventionNames': ['Device: Cypher']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endeavor Resolute', 'description': 'Zotarolimus-eluting Stent', 'interventionNames': ['Device: Endeavor Resolute']}], 'interventions': [{'name': 'Cypher', 'type': 'DEVICE', 'otherNames': ['Sirolimus-eluting stent'], 'description': 'Sirolimus-eluting stent', 'armGroupLabels': ['Cypher']}, {'name': 'Endeavor Resolute', 'type': 'DEVICE', 'otherNames': ['Zotarolimus-eluting Stent'], 'description': 'Zotarolimus-eluting Stent', 'armGroupLabels': ['Endeavor Resolute']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suncheon', 'state': 'Cheon-nam', 'country': 'South Korea', 'facility': 'Stcarollo Hospital', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}, {'city': 'Daejeon', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Konyang University Hospital'}, {'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Ilsan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital'}, {'city': 'Daegu', 'state': 'Kyung-book', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Medical Center', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soonchunhyang University Cheonan Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Gangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, 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'}, {'name': 'Medtronic', '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'}}}}