Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT00388934
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2006-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Cypher Select and Taxus Express Coronary Stents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], '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'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2095}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2006-10-16', 'studyFirstSubmitQcDate': '2006-10-16', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)', 'timeFrame': 'during 9 months'}], 'secondaryOutcomes': [{'measure': 'Total death', 'timeFrame': 'after 9 months, 2 and 3 years'}, {'measure': 'Cardiac death', 'timeFrame': 'after 9 months, 2 and 3 years'}, {'measure': 'Myocardial infarction', 'timeFrame': 'after 9 months, 2 and 3 years'}, {'measure': 'Target vessel revascularisation, target lesion revascularisation, TVF', 'timeFrame': 'after 9 months, 2 and 3 years'}, {'measure': 'Stent thrombosis', 'timeFrame': 'after 9 months, 2 and 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Angina pectoris', 'Stent'], 'conditions': ['Coronary Artery Disease', 'Angina Pectoris']}, 'referencesModule': {'references': [{'pmid': '28183505', 'type': 'DERIVED', 'citation': 'Galloe AM, Kelbaek H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, Christiansen EH, Abildgaard U, Stephansen G, Lassen JF, Engstrom T, Jensen JS, Jeppesen JL, Bligaard N; SORT OUT II Investigators. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. J Am Coll Cardiol. 2017 Feb 14;69(6):616-624. doi: 10.1016/j.jacc.2016.11.055.'}, {'pmid': '18230778', 'type': 'DERIVED', 'citation': 'Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.'}]}, 'descriptionModule': {'briefSummary': 'Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.', 'detailedDescription': 'Design:\n\n* Randomized open multicentre trial.\n\nPatients:\n\n* 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.\n\nInclusion criteria:\n\n* Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.\n* Signed informed consent.\n\nExclusion criteria:\n\n* Participation in other stent studies.\n\nRandomization:\n\n* Implantation of Taxus Express og Cypher Select stents.\n\nPrimary end-point:\n\n* Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months.\n\nSecondary end-points:\n\n* Total death after nine months\n* Cardiac death after nine months\n* Myocardial infarction after nine months\n* Index vessel myocardial infarction after nine months\n* Target lesion revascularization\n* Target vessel revascularization\n* Stent thrombosis after nine months\n\nEnd-point evaluation:\n\n* End-points will be adjudicated by an independent end-point committee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned implantation of drug eluting stent\n* Written informed consent\n\nExclusion Criteria:\n\n* Planned intervention with other stents than study stents'}, 'identificationModule': {'nctId': 'NCT00388934', 'acronym': 'SORT-OUTII', 'briefTitle': 'Comparison of Cypher Select and Taxus Express Coronary Stents', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.', 'orgStudyIdInfo': {'id': 'SORT-OUT II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug eluting stent (Cypher)', 'description': 'Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)', 'interventionNames': ['Device: Drug eluting stent']}, {'type': 'EXPERIMENTAL', 'label': 'Drug eluting stent (Taxus)', 'description': 'Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)', 'interventionNames': ['Device: Drug eluting stent']}], 'interventions': [{'name': 'Drug eluting stent', 'type': 'DEVICE', 'otherNames': ['DES', 'Cypher', 'Taxus'], 'description': 'percutaneous intervention with implantation of drug eluting coronary stent', 'armGroupLabels': ['Drug eluting stent (Cypher)', 'Drug eluting stent (Taxus)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anders Galloe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital Skejby', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Department of Cardiology B', 'oldOrganization': 'Aarhus University Hospital Skejby'}}}}