Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02796157
Status:
UNKNOWN
Last Update Posted:
2018-05-18
First Post:
2016-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 950}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of composite of major adverse cardiovascular events', 'timeFrame': '1 year after PCI', 'description': 'Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bioresorbable vascular scaffold, drug eluting stent, coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '32279841', 'type': 'DERIVED', 'citation': 'Seo J, Ahn JM, Hong SJ, Kang DY, Hong SJ, Her AY, Kim YH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Park DW, Hong MK. Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. Am J Cardiol. 2020 Jun 1;125(11):1624-1630. doi: 10.1016/j.amjcard.2020.02.031. Epub 2020 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-85 years\n* Patients with ischemic heart disease requiring PCI\n* Significant coronary de novo lesion (stenosis \\>50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation\n* Reference vessel diameter of 2.5 to 3.75 mm by operator assessment\n\nExclusion Criteria:\n\n* Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support\n* Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique\n* Contraindication or hypersensitivity to anti-platelet agents or contrast media\n* Treated with any metallic stent or BVS within 3 months at other vessel\n* Cardiogenic shock\n* Left ventricular ejection fraction \\<40%\n* Pregnant women or women with potential childbearing\n* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator\n* Inability to understand or read the informed content'}, 'identificationModule': {'nctId': 'NCT02796157', 'briefTitle': 'A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2016-0025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'absorb arm', 'description': 'PCI with Absorb everolimus-eluting bioresorbable vascular scaffold', 'interventionNames': ['Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold']}, {'type': 'EXPERIMENTAL', 'label': 'Xience arm', 'description': 'PCI with Xience everolimus-eluting metallic stent', 'interventionNames': ['Device: PCI with Xience everolimus-eluting metallic stent']}], 'interventions': [{'name': 'PCI with Absorb everolimus-eluting bioresorbable vascular scaffold', 'type': 'DEVICE', 'description': 'Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.', 'armGroupLabels': ['absorb arm']}, {'name': 'PCI with Xience everolimus-eluting metallic stent', 'type': 'DEVICE', 'description': 'Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.', 'armGroupLabels': ['Xience arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MYEONG-KI HONG, MD', 'role': 'CONTACT', 'email': 'MKHONG61@yuhs.ac', 'phone': '82-2-2228-8458'}], 'facility': 'Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}