Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-01 @ 10:43 PM
Study NCT ID:
NCT01489761
Status:
TERMINATED
Last Update Posted:
2017-02-24
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-09', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-segment late luminal loss at 13 month follow-up', 'timeFrame': '13 month post stenting'}], 'secondaryOutcomes': [{'measure': '1. All Death', 'timeFrame': '12 month clinical follow-up'}, {'measure': '2. Cardiac death', 'timeFrame': '12 month clinical follow-up'}, {'measure': '3. Myocardial infarction (MI)', 'timeFrame': '12 month clinical follow-up'}, {'measure': '4. Composite of death or MI', 'timeFrame': '12 month clinical follow-up'}, {'measure': '5. Composite of cardiac death or MI', 'timeFrame': '12 month clinical follow-up'}, {'measure': '6. Target vessel revascularization (ischemia-driven and clinically-driven)', 'timeFrame': '12 month clinical follow-up'}, {'measure': '7. Target lesion revascularization (ischemia-driven and clinically-driven)', 'timeFrame': '12 month clinical follow-up'}, {'measure': '8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)', 'timeFrame': '12 month clinical follow-up'}, {'measure': '9. Stent thrombosis (ARC criteria)', 'timeFrame': '12 month clinical follow-up'}, {'measure': '10. In-stent late loss', 'timeFrame': '13 month angiographic follow-up'}, {'measure': '11. In-stent and in-segment restenosis', 'timeFrame': '13 month angiographic follow-up'}, {'measure': '12. Angiographic pattern of restenosis', 'timeFrame': '13 month angiographic follow-up'}, {'measure': '13. Volume of intimal hyperplasia', 'timeFrame': '13 month IVUS follow-up', 'description': 'sub-study'}, {'measure': '14. Incidence of late stent malapposition', 'timeFrame': '13 month IVUS follow-up', 'description': 'sub-study'}, {'measure': '15. 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': '2-3 days post stenting'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['long lesions', 'drug eluting stents'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.', 'detailedDescription': 'Following angiography, patients with significant diameter stenosis \\> 50% and lesion length (\\> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 20 years\n* Significant native coronary artery stenosis (\\> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment\n* Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)\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, zotarolimus, 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) However, non-target vessel In-stent restenosis is permitted\n* Patients with EF \\< 30%\n* Serum creatinine level \\>=2.0mg/dL or dependence on dialysis\n* Patients with left main stem stenosis (\\> 50% visual estimate)'}, 'identificationModule': {'nctId': 'NCT01489761', 'briefTitle': 'LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents', 'orgStudyIdInfo': {'id': 'CVRF2011-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'zotarolimus-eluting stent', 'description': 'Resolute Integrity or Resolute Onyx stent', 'interventionNames': ['Device: percutaneous coronary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'everolimus-eluting stent', 'description': 'Xience Prime or Xience Xpedition or Xience Alpine stent', 'interventionNames': ['Device: percutaneous coronary intervention']}], 'interventions': [{'name': 'percutaneous coronary intervention', 'type': 'DEVICE', 'otherNames': ['Resolute Integrity or Resolute Onyx stent', 'Xience Prime or Xience Xpedition or Xience Alpine stent'], 'description': 'drug eluting stent implantation', 'armGroupLabels': ['everolimus-eluting stent', 'zotarolimus-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'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': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National university hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Daejeon ST. Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyunghee University Medical Center', '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': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not a publicly funded trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}