Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT01080859
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2010-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D020163', 'term': 'Ornithine Carbamoyltransferase Deficiency Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D056806', 'term': 'Urea Cycle Disorders, Inborn'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2010-03-03', 'studyFirstSubmitQcDate': '2010-03-03', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncovered stent struts', 'timeFrame': '6-8 months', 'description': 'OCT number of uncovered stent struts for BAS versus EES.'}], 'secondaryOutcomes': [{'measure': 'Cardiac death,MI, stent thrombosis (ST) and TLR.', 'timeFrame': '1, 6, 12 and 18 months', 'description': 'Device oriented composite endpoint, defined as cardiac death,MI, stent thrombosis (ST) and TLR at at 1, 6, 12 and 18 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['titanium', 'everolimus', 'oct', 'acute coronary syndrome', 'stent', 'pci', 'stenting'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '23996244', 'type': 'DERIVED', 'citation': 'Karjalainen P, Kiviniemi TO, Lehtinen T, Nammas W, Ylitalo A, Saraste A, Mikkelsson J, Pietila M, Biancari F, Airaksinen JK. Neointimal coverage and vasodilator response to titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents in patients with acute coronary syndrome: insights from the BASE-ACS trial. Int J Cardiovasc Imaging. 2013 Dec;29(8):1693-703. doi: 10.1007/s10554-013-0285-8. Epub 2013 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute coronary syndrome.', 'detailedDescription': 'A prospective, randomized and controlled study comparing the coverage of the BAS and EES implanted in acute coronary syndrome.\n\nClinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with acute coronary syndrome and who were treated either BAS or EES during the index PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is ≥ 18 years old;\n* The patient is presenting with acute coronary syndrome, and according to hospital routine practice, eligible for percutaneous coronary intervention;\n* Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site.\n\nExclusion Criteria:\n\n* Lesions in coronary artery bypass grafts\n* Left main disease\n* Killip class III-IV\n* Allergy to aspirin / thienopyridine\n* Patient in anticoagulation therapy\n* No suitable anatomy for OCT scan\n* Ostial lesion\n* Tortuosity anatomy\n* Very distal lesion\n* Vessel size \\> 3.75 mm"}, 'identificationModule': {'nctId': 'NCT01080859', 'acronym': 'BASE-OCT', 'briefTitle': 'Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital District of Satakunta'}, 'officialTitle': 'Early Coverage and Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Implanted in Acute Coronary Syndrome Assessed By Optical Coherence Tomography (BASE-OCT)', 'orgStudyIdInfo': {'id': 'SA-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BAS', 'description': "Patient's receiving BAS", 'interventionNames': ['Device: OCT']}, {'label': 'EES', 'description': 'Patients receiving EES', 'interventionNames': ['Device: OCT']}], 'interventions': [{'name': 'OCT', 'type': 'DEVICE', 'otherNames': ['TITAN-2, Hexacath, France'], 'description': 'Optical coherence tomography', 'armGroupLabels': ['BAS']}, {'name': 'OCT', 'type': 'DEVICE', 'otherNames': ['Xience-V, Abbott vascular, USA'], 'description': 'Optical coherence tomography', 'armGroupLabels': ['EES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28500', 'city': 'Pori', 'country': 'Finland', 'facility': 'Satakunta Central Hospital', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}], 'overallOfficials': [{'name': 'Pasi P Karjalainen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satakunta Central Hospital, Pori, Finland'}, {'name': 'Antti Ylitalo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Satakunta Central Hospital, Pori, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital District of Satakunta', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Satakun Hospital District', 'oldOrganization': 'Satakunta Central Hospital'}}}}