Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT00165035
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1701}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death', 'timeFrame': '8 months'}, {'measure': 'In-segment late lumen loss', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Device, lesion and procedure success', 'timeFrame': 'At procedure or hospital discharge'}, {'measure': 'Incidence of MACE', 'timeFrame': '30 days, 9 months and 12 months'}, {'measure': 'Coronary angiography in the angiographic cohort', 'timeFrame': '9 months'}, {'measure': 'Target lesion revascularization', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention (PCI)', 'Drug eluting stent (DES)'], 'conditions': ['Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '18599890', 'type': 'RESULT', 'citation': 'Kereiakes DJ, Petersen JL, Batchelor WB, Fitzgerald PJ, Mehran R, Lansky A, Tsujino I, Schofer J, Dubois C, Verheye S, Cristea E, Garg J, Wijns W, Krucoff MW. Clinical and angiographic outcomes in diabetic patients following single or multivessel stenting in the COSTAR II randomized trial. J Invasive Cardiol. 2008 Jul;20(7):335-41.'}, {'pmid': '18420096', 'type': 'RESULT', 'citation': "Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA 3rd, Verheye S, Dubois CL, Gammon R, Batchelor WB, O'Shaughnessy CD, Hermiller JB Jr, Schofer J, Buchbinder M, Wijns W; COSTAR II Investigators Group. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J Am Coll Cardiol. 2008 Apr 22;51(16):1543-52. doi: 10.1016/j.jacc.2008.01.020."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.', 'detailedDescription': 'Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria:\n\n* Eligible for percutaneous coronary intervention (PCI)\n* Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia\n* Documented LVEF ≥25% within the last 6 weeks.\n* Eligible for coronary artery bypass graft surgery (CABG)\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n* Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.\n* Planned treatment with any other PCI device in the target vessel(s).\n* MI within 72 hours prior to the index procedure\n* Patient is in cardiogenic shock\n* Cerebrovascular Accident (CVA) within the past 6 months\n* Acute or chronic renal dysfunction (creatinine \\>2.0 mg/dl or \\>150 µmol/L)\n* Contraindication to ASA or to clopidogrel\n* Thrombocytopenia\n* Active GI bleeding within past three months\n* Known allergy to stainless steel or cobalt chromium\n* Any prior true anaphylactic reaction to contrast agents\n* Patient is currently taking colchicine'}, 'identificationModule': {'nctId': 'NCT00165035', 'briefTitle': 'Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'Multi-Center, Single-Blind, Two-Arm, Randomized, Controlled, Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries', 'orgStudyIdInfo': {'id': 'COSTAR II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES', 'interventionNames': ['Device: CoStar Paclitaxel Drug Eluting Coronary Stent System']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent', 'interventionNames': ['Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent']}], 'interventions': [{'name': 'CoStar Paclitaxel Drug Eluting Coronary Stent System', 'type': 'DEVICE', 'description': 'Drug eluting stent', 'armGroupLabels': ['1']}, {'name': 'TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent', 'type': 'DEVICE', 'description': 'Drug eluting stent', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Christ Linder', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Dean J Kereiakes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Christ Hospital, Cincinnati, Ohio'}, {'name': 'Mitchell W Krucoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Medical Center, Durham, NC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Conor Medsystems', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mitch W Krucoff, MD, Principal Investigator', 'oldOrganization': 'Duke University Medical Center'}}}}