Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02770651
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2016-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2016-05-01', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups', 'timeFrame': '12month', 'description': 'Incidence of malapposed and uncovered stent strut measured by OCT'}], 'secondaryOutcomes': [{'measure': 'Percent neointima cross-sectional area', 'timeFrame': '12month', 'description': 'By OCT, percentage neointima cross sectional area can be obtained by dividing the neointimal area by the stent area.(neointima cross-sectional area in mm²(Quadratmillimeter)/sec)'}, {'measure': 'Mean neointima thickness', 'timeFrame': '12month', 'description': 'By OCT, neointima thickness can be measured as distance from the endoluminal surface of the neointima to the stent strut.(mean neointima thickness in millimeter)'}, {'measure': 'Morphologic characteristics of neointima', 'timeFrame': '12month', 'description': 'Morphologic characteristics of neointima measured by OCT(morphologic characteristics of neointima is one of fibrous, fibrocalcific, lipid-laden)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['optical coherence tomography', 'everolimus-eluting stent', 'zotarolimus-eluting stent'], 'conditions': ['Coronary Artery Disease', 'Coronary Disease', 'Myocardial Ischemia', 'Arterial Occlusive Diseases', 'Arteriosclerosis', 'Cardiovascular Diseases', 'Heart Diseases', 'Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '25033105', 'type': 'BACKGROUND', 'citation': 'Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Mintz GS, Gao RL. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014 Nov;10(7):806-14. doi: 10.4244/EIJY14M07_17.'}, {'pmid': '22179532', 'type': 'BACKGROUND', 'citation': 'Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.'}, {'pmid': '23040589', 'type': 'BACKGROUND', 'citation': 'Kim S, Kim JS, Shin DH, Kim BK, Ko YG, Choi D, Cho YK, Nam CW, Hur SH, Jang Y, Hong MK. Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. Am J Cardiol. 2013 Jan 1;111(1):1-5. doi: 10.1016/j.amjcard.2012.08.037. Epub 2012 Oct 2.'}, {'pmid': '25502167', 'type': 'BACKGROUND', 'citation': 'Karjalainen PP, Varho V, Nammas W, Mikkelsson J, Pietila M, Ylitalo A, Airaksinen JK, Sia J, Nyman K, Biancari F, Kiviniemi T. Early neointimal coverage and vasodilator response following biodegradable polymer sirolimus-eluting vs. durable polymer zotarolimus-eluting stents in patients with acute coronary syndrome -HATTRICK-OCT trial. Circ J. 2015;79(2):360-7. doi: 10.1253/circj.CJ-14-1000. Epub 2014 Dec 15.'}, {'pmid': '40421609', 'type': 'DERIVED', 'citation': 'Lee CH, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Kim H, Nam CW, Hur SH. Late stent strut apposition and coverage after drug-eluting stent implantation by optical coherence tomography in patients with acute myocardial infarction. Coron Artery Dis. 2025 Nov 1;36(7):610-617. doi: 10.1097/MCA.0000000000001536. Epub 2025 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.', 'detailedDescription': 'It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release. Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes. However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis. Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI\n* Patient ≥ 18 years of age\n* Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure\n* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.\n* culprit lesion\n\nExclusion Criteria:\n\n* The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media\n* Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment\n* Cardiogenic shock\n* Patient with left ventricular ejection fraction \\<30%\n* Patient with left main disease\n* Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted)\n* Patient with impaired renal function (creatinine \\>2.0mg/dL)\n* Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts\n* bifucation lesion needs complex procedure with insert two or more Drug eluting stents.\n* lesion length \\>30mm'}, 'identificationModule': {'nctId': 'NCT02770651', 'briefTitle': 'Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'LAte Stent Strut APPosition and COverage After Drug-Eluting Stent ImplantaTIOn by Optical Coherence Tomography in PatieNts With Acute Myocardial Infarction II(APPOSITION-AMI II)', 'orgStudyIdInfo': {'id': '2016-01-030'}, 'secondaryIdInfos': [{'id': 'APPOSITION-AMI II', 'type': 'OTHER', 'domain': 'Keimyung University Dongsan Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Optical Coherence Tomography', 'description': 'To evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.', 'interventionNames': ['Device: Everolimus-Eluting stent', 'Device: Zotarolimus-Eluting stent']}], 'interventions': [{'name': 'Everolimus-Eluting stent', 'type': 'DEVICE', 'otherNames': ['Synergy™'], 'description': 'Everolimus-Eluting stent with bioabsorbable polymer', 'armGroupLabels': ['Optical Coherence Tomography']}, {'name': 'Zotarolimus-Eluting stent', 'type': 'DEVICE', 'otherNames': ['Resolute Onyx™'], 'description': 'Zotarolimus-Eluting stent with permanent polymer', 'armGroupLabels': ['Optical Coherence Tomography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Seung-Ho Hur, Postdoctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Seung-Ho Hur', 'investigatorAffiliation': 'Keimyung University Dongsan Medical Center'}}}}