Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT01879358
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2013-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2314}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2013-06-14', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac death, myocardial infarction or target lesion revascularization', 'timeFrame': '12 months', 'description': 'Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization)'}], 'secondaryOutcomes': [{'measure': 'Cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization, all cause mortality, stent thrombosis', 'timeFrame': '12 months', 'description': 'Cardiac mortality Myocardial infarction Target lesion revascularization Target vessel revascularization All cause mortality Stent thrombosis rate according to the Academic Research Consortium definition Secondary endpoints will be assessed after 1 year, 2 years, 3 years, 4 years and 5 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug-eluting stent', 'Safety', 'Efficacy'], 'conditions': ['Coronary Artery Disease', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '22308301', 'type': 'BACKGROUND', 'citation': 'Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012 Mar 13;125(10):1246-55. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3.'}, {'pmid': '39311502', 'type': 'DERIVED', 'citation': 'Troan J, Christiansen EH, Hansen KN, Eftekhari A, Jakobsen L, Maeng M, Freeman P, Jensen RV, Christensen MK, Noori M, Ellert-Gregersen J, Stottrup NB, Kahlert J, Veien KT, Jensen LO. Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial. Diab Vasc Dis Res. 2024 Sep-Oct;21(5):14791641241283939. doi: 10.1177/14791641241283939.'}, {'pmid': '36649389', 'type': 'DERIVED', 'citation': 'Hansen KN, Jensen LO, Maeng M, Christensen MK, Noori M, Kahlert J, Jakobsen L, Junker A, Freeman P, Ellert-Gregersen J, Raungaard B, Terkelsen CJ, Veien KT, Christiansen EH. Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial. Circ Cardiovasc Interv. 2023 Jan;16(1):e012332. doi: 10.1161/CIRCINTERVENTIONS.122.012332. Epub 2023 Jan 17.'}, {'pmid': '27412869', 'type': 'DERIVED', 'citation': 'Jensen LO, Thayssen P, Maeng M, Ravkilde J, Krusell LR, Raungaard B, Junker A, Terkelsen CJ, Veien KT, Villadsen AB, Kaltoft A, Tilsted HH, Hansen KN, Aaroe J, Kristensen SD, Hansen HS, Jensen SE, Madsen M, Botker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial. Circ Cardiovasc Interv. 2016 Jul;9(7):e003610. doi: 10.1161/CIRCINTERVENTIONS.115.003610.'}, {'pmid': '26299216', 'type': 'DERIVED', 'citation': 'Jensen LO, Thayssen P, Maeng M, Ravkilde J, Hansen HS, Jensen SE, Botker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome VII trial. Am Heart J. 2015 Aug;170(2):210-5. doi: 10.1016/j.ahj.2015.05.009. Epub 2015 May 22.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22308301', 'label': 'SORT OUT IV with same clinically event driven methodology'}]}, 'descriptionModule': {'briefSummary': 'The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the biolimus-eluting NOBORI stent in a population-based setting, using registry detection of clinically driven events', 'detailedDescription': 'SORT OUT VII is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the sirolimus eluting ORSIRO stent to the biolimus-eluting NOBORI stent in treating atherosclerotic coronary artery lesions.\n\nPrimary Endpoint:\n\nTarget lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).\n\nSecondary Endpoints:\n\nIndividual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).\n\nClinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death\n\nInclusion criteria:\n\nat least 18 years old chronic stable coronary artery disease or acute coronary syndromes at least one coronary artery lesion with more than 50% diameter stenosis requiring treatment with a drug-eluting stent\n\nExclusion criteria:\n\nlife expectancy of less than one year allergy to aspirin, clopidogrel, sirolimus, or biolimus participation in another randomized trial nability to provide written informed consent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. There are no restrictions on number of treated lesions, number of treated vessels, or lesion length.\n\nExclusion Criteria:\n\n* Exclusion criteria are life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, sirolimus, or biolimus; participation in another randomized trial; or inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01879358', 'acronym': 'SORT OUT VII', 'briefTitle': 'Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Randomized Comparison of a Sirolimus Eluting ORSIRO Stent With a Biolimus-eluting NOBORI Stent in Patients Treated With Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'SORT OUT VII'}, 'secondaryIdInfos': [{'id': 'OUH', 'type': 'OTHER', 'domain': 'Odense University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ORSIRO stent', 'description': 'ORSIRO stent group', 'interventionNames': ['Device: Drug-eluting stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NOBORI stent', 'description': 'NOBORI stent group', 'interventionNames': ['Device: Drug-eluting stent']}], 'interventions': [{'name': 'Drug-eluting stent', 'type': 'DEVICE', 'otherNames': ['ORSIRO sirolimus-eluting stent', 'NOBORI biolimus-eluting stent'], 'armGroupLabels': ['NOBORI stent', 'ORSIRO stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jens F Lassen, MD DMSci', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD DMSci PhD', 'investigatorFullName': 'Lisette Okkels Jensen', 'investigatorAffiliation': 'Odense University Hospital'}}}}