Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 6:10 PM
Study NCT ID:
NCT01875835
Status:
TERMINATED
Last Update Posted:
2024-12-02
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Difficulty in enrolling the required number of participants has made it impractical to proceed with the trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).', 'timeFrame': '3-month', 'description': 'The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.', 'timeFrame': '12-month', 'description': 'The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.'}, {'measure': 'Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.', 'timeFrame': '3-month', 'description': 'Strut malapposition is defined as struts detached from the vessel wall \\> 108μm for EES and \\> 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.'}, {'measure': 'Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.', 'timeFrame': '12-month', 'description': 'Strut malapposition is defined as struts detached from the vessel wall \\> 108μm for EES and \\> 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.'}, {'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': '12-month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute myocardiac infarction', 'Bare-metal stent', 'Everolimus-eluting stent', 'Optical coherence tomography'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.\n\nHowever, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-75 years\n* Acute MI with ST-segment elevation, within 12 hours from symptoms onset.\n* Length of culprit lesion≤25mm.\n* Vessel size in between 2.5 and 4.0 mm.\n* Signed patient informed consent.\n\nExclusion Criteria:\n\n* Prior administration of thrombolytic therapy.\n* Cardiogenic shock.\n* Renal failure (Crea≥2.0mg/dL).\n* Recent major bleeding.\n* Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.\n* Left main disease\n* Multi-vessel lesion\n* Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)\n* Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.\n* No suitable anatomy for OCT scan.'}, 'identificationModule': {'nctId': 'NCT01875835', 'acronym': 'NeoCover', 'briefTitle': 'Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Harbin Medical University'}, 'officialTitle': 'Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'HMUOCT-STEMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DES', 'description': 'Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)', 'interventionNames': ['Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS', 'description': 'Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)', 'interventionNames': ['Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)']}], 'interventions': [{'name': 'Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)', 'type': 'DEVICE', 'armGroupLabels': ['DES']}, {'name': 'Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)', 'type': 'DEVICE', 'armGroupLabels': ['BMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'overallOfficials': [{'name': 'Bo Yu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Harbin Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The second affiliated hospitai of Harbin medical university', 'investigatorFullName': 'Yu Bo', 'investigatorAffiliation': 'Harbin Medical University'}}}}