Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-28 @ 3:52 AM
Study NCT ID:
NCT02831205
Status:
TERMINATED
Last Update Posted:
2017-12-15
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
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': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'whyStopped': 'Due to current BVS safety issue', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '1 year', 'description': 'event rate for composite of cardiac death, target-vessel myocardial infarction \\[MI\\], or ischemia-driven target-lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '5 years'}, {'measure': 'Target-vessel myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'Ischemia-driven target-lesion revascularization', 'timeFrame': '5 years'}, {'measure': 'All-cause mortality', 'timeFrame': '5 years'}, {'measure': 'event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'Any revascularization', 'timeFrame': '5 years', 'description': 'Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven'}, {'measure': 'Target-vessel failure', 'timeFrame': '5 years', 'description': 'death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization'}, {'measure': 'Stent thrombosis', 'timeFrame': '5 years'}, {'measure': 'event rate of device success or procedural success', 'timeFrame': '5 years', 'description': 'Device success defined as angiographic evidence of \\<30% final residual stenosis of the target lesion.\n\nProcedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death.'}, {'measure': 'Patient-reported angina status measured by Seattle angina questionnaire', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bioresorbable vascular scaffold', 'coronary artery disease'], 'conditions': ['Percutaneous Transluminal Coronary Angioplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 and more\n* Diffuse long native coronary artery stenosis (\\>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment\n* Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI\n* The patient or guardian agrees to the study protocol and the schedule of clinical 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* Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated\n* Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication\n* An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure\n* STEMI requiring primary percutaneous coronary intervention\n* Cardiogenic shock\n* Restenotic lesions\n* Left main\n* Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion\n* Heavy calcification proximal to or within the target lesion\n* Compromised left ventricular dysfunction (LVEF \\<30%)\n* At the time of screening, the subject has a malignancy that is not in remission\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* Patient's pregnant or breast-feeding or child-bearing potential"}, 'identificationModule': {'nctId': 'NCT02831205', 'acronym': 'ABSORB-LONG', 'briefTitle': 'Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'AMCCV2016-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABSORB BVS', 'interventionNames': ['Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'XIENCE EES', 'interventionNames': ['Device: everolimus-eluting cobalt-chromium (Xience) stent']}], 'interventions': [{'name': 'everolimus-eluting bioresorbable vascular (Absorb) scaffold', 'type': 'DEVICE', 'otherNames': ['ABSORB BVS'], 'armGroupLabels': ['ABSORB BVS']}, {'name': 'everolimus-eluting cobalt-chromium (Xience) stent', 'type': 'DEVICE', 'otherNames': ['XIENCE EES'], 'armGroupLabels': ['XIENCE EES']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not a publicly funded trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duk-Woo Park, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor of medicine', 'investigatorFullName': 'Duk-Woo Park, MD', 'investigatorAffiliation': 'Asan Medical Center'}}}}