Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03484234
Status:
TERMINATED
Last Update Posted:
2019-09-10
First Post:
2018-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': "At sponsor's discretion : The purpose of study is no longer maintained", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-08', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-segment late luminal loss', 'timeFrame': '13-month'}], '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', 'timeFrame': '1 year', 'description': 'death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization'}, {'measure': 'Stent thrombosis', 'timeFrame': '1 year'}, {'measure': 'In-stent late loss', 'timeFrame': '13-month', 'description': 'In-stent late loss at 13-month angiographic follow-up'}, {'measure': 'In-stent and in-segment restenosis', 'timeFrame': '13-month', 'description': 'In-stent and in-segment restenosis at 13-month angiographic follow-up'}, {'measure': 'Angiographic pattern of restenosis', 'timeFrame': '13-month', 'description': 'Angiographic pattern of restenosis at 13 -month angiographic follow-up'}, {'measure': 'Volume of intimal hyperplasia', 'timeFrame': '13-month', 'description': 'Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)'}, {'measure': 'Incidence of late stent malapposition', 'timeFrame': '13-month', 'description': 'Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)'}, {'measure': 'Procedural success', 'timeFrame': '5 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug eluting stent', 'everolimus eluting stent', 'sirolimus eluting stent'], 'conditions': ['Coronary Artery Disease', 'Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient must be at least 19 years of age.\n2. Significant native coronary artery stenosis (\\>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.\n3. Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)\n4. 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\n1. Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus\n2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.\n3. Acute ST-segment-elevation MI or cardiogenic shock\n4. Terminal illness with life expectancy \\<1 year\n5. In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.\n6. Patients with EF\\<30%.\n7. Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.\n8. Patients with left main stem stenosis (\\>50% by visual estimate)'}, 'identificationModule': {'nctId': 'NCT03484234', 'acronym': 'LONG-DES VII', 'briefTitle': 'Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Multi-center, Randomized, Study to Compare the Effectiveness of Sirolimus-eluting Stent (Ultimaster Stent) or Everolimus-eluting Stent (XIience Alpine Stent) for Long Coronary Lesions.', 'orgStudyIdInfo': {'id': 'AMCCV2018-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultimaster stent', 'interventionNames': ['Device: Ultimaster stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xience alpine stent', 'interventionNames': ['Device: Xience alpine stent']}], 'interventions': [{'name': 'Ultimaster stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention with Ultimaster stent for long lesion', 'armGroupLabels': ['Ultimaster stent']}, {'name': 'Xience alpine stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention with Xience alpine stent for long lesion', 'armGroupLabels': ['Xience alpine stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Gangwon National Univ. Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, '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 Cardiology', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}