Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00225693
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
V-Flex Plus PTX Drug Eluting Coronary Stent
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2005-07'}, 'lastUpdateSubmitDate': '2012-01-30', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-23', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation by IVUS of % diameter stenosis at follow up.'}], 'secondaryOutcomes': [{'measure': 'Major adverse events'}, {'measure': 'Target lesion revascularization'}]}, 'conditionsModule': {'keywords': ['coronary artery', 'restenosis', 'patency', 'drug eluting', 'stent'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.\n* Patient must be an acceptable candidate for coronary artery bypass surgery\n* Patient or legal guardian must have given informed consent\n* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.\n\nExclusion Criteria:\n\n* Patient must be less than 18 years old\n* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.\n* Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.\n* Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.\n* Women of child bearing potential.\n* Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.'}, 'identificationModule': {'nctId': 'NCT00225693', 'acronym': 'ELUTES III', 'briefTitle': 'V-Flex Plus PTX Drug Eluting Coronary Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent', 'orgStudyIdInfo': {'id': '578'}}, 'armsInterventionsModule': {'interventions': [{'name': 'drug eluting coronary stent', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Contact Sponsor', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Joseph Dens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Gasthuisberg Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}}}}