Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT00415961
Status:
TERMINATED
Last Update Posted:
2009-01-09
First Post:
2006-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-08', 'studyFirstSubmitDate': '2006-12-22', 'studyFirstSubmitQcDate': '2006-12-22', 'lastUpdatePostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-segment late lumen loss at 9 months, as measured by QCA.', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months', 'timeFrame': 'MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months'}]}, 'conditionsModule': {'keywords': ['Percutaneous Coronary Intervention (PCI)', 'Drug-eluting stent (DES)'], 'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': 'This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.', 'detailedDescription': 'This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '20 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.\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 ticlopidine\n* Thrombocytopenia\n* Active GI bleeding within past three months\n* Known allergy to cobalt chromium\n* Any prior true anaphylactic reaction to contrast agents'}, 'identificationModule': {'nctId': 'NCT00415961', 'briefTitle': 'Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Conor Medsystems'}, 'officialTitle': 'Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety', 'orgStudyIdInfo': {'id': 'CI-CMS-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CoStar Paclitaxel drug eluting stent', 'interventionNames': ['Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System']}], 'interventions': [{'name': 'CoStar Paclitaxel Drug-Eluting Coronary Stent System', 'type': 'DEVICE', 'description': 'CoStar Paclitaxel Drug-Eluting Coronary Stent System', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '247-8533', 'city': 'Kamakura', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}], 'overallOfficials': [{'name': 'Shigeru Saito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ShonanKamakura General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Conor Medsystems', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Getz Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Shigeru Saito, MD', 'oldOrganization': 'ShonanKamakura General Hospital'}}}}