Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT00233766
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2005-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-17', 'studyFirstSubmitDate': '2005-10-04', 'studyFirstSubmitQcDate': '2005-10-04', 'lastUpdatePostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.', 'timeFrame': 'four-months and twelve-months post-procedure'}, {'measure': 'NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.', 'timeFrame': 'four-months and twelve-months post-procedure'}, {'measure': 'Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.', 'timeFrame': 'four-months and twelve months post-procedure'}, {'measure': 'Four and twelve month target vessel failure (TVF).', 'timeFrame': 'Four and twelve month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '17621671', 'type': 'BACKGROUND', 'citation': 'Nakamura M, Abizaid A, Hirohata A, Honda Y, Sousa JE, Fitzgerald PJ. Efficacy of reduced-dose sirolimus-eluting stents in the human coronary artery: serial IVUS analysis of neointimal hyperplasia and luminal dimension. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):946-51. doi: 10.1002/ccd.21272.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or non-pregnant female patient minimum 18 years of age\n2. No significant (\\>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;\n3. Target lesion is 18mm in length (visual estimate);\n4. Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);\n5. Target lesion stenosis is \\>50% and \\<100% (visual estimate);\n\nExclusion Criteria:\n\n1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;\n2. Ejection fraction 30%;\n3. Stent placement of target lesion covers a side branch \\>2.0mm in diameter;'}, 'identificationModule': {'nctId': 'NCT00233766', 'briefTitle': 'Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX)', 'orgStudyIdInfo': {'id': 'P02-6314'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'J. E. Sousa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Dante Pazzanese de Cardiologia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'J. E. Sousa, MD', 'oldOrganization': 'Instituto Dante Pazzanese de Cardiologia'}}}}