Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-04-12 @ 8:03 PM
Study NCT ID:
NCT00552994
Status:
COMPLETED
Last Update Posted:
2010-07-12
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2007-10-31', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In stent neointimal hyperplasia', 'timeFrame': 'Within 10 months'}], 'secondaryOutcomes': [{'measure': 'Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss', 'timeFrame': 'Within 10 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug eluting stent', 'Diabetics', 'Intravascular ultrasound', 'Pathophysiologic (neointimal hyperplasia and peri-stent remodeling)'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23996918', 'type': 'DERIVED', 'citation': 'Antonsen L, Maeng M, Thayssen P, Christiansen EH, Hansen KN, Kaltoft A, Hansen HS, Thuesen L, Lassen JF, Jensen LO. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial. Catheter Cardiovasc Interv. 2014 May 1;83(6):864-72. doi: 10.1002/ccd.25180. Epub 2013 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.\n\nExclusion Criteria:\n\n* The patient will not participate\n* The patient participates in other randomised stent studies\n* Expected survival \\< 1 year\n* Allergy to Aspirin, Clopidogrel or Ticlopidine\n* Allergy to Sirolimus or ABT-578'}, 'identificationModule': {'nctId': 'NCT00552994', 'acronym': 'DIABEDES IV', 'briefTitle': 'Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'A Danish Prospective Randomized Multicenter Comparison of the Xience V and the Cypher Select+ Stents in Unselective Patients With Diabetes Mellitus. An Intravascular Ultrasound Study.', 'orgStudyIdInfo': {'id': 'IVUS-20070043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Cypher Select plus stent', 'interventionNames': ['Device: Cypher Select plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Xience V stent', 'interventionNames': ['Device: Xience V stent']}], 'interventions': [{'name': 'Cypher Select plus', 'type': 'DEVICE', 'description': 'Drug eluting stent', 'armGroupLabels': ['1']}, {'name': 'Xience V stent', 'type': 'DEVICE', 'description': 'Drug eluting stent', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Per Thayssen, MD DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lisette Okkels Jensen', 'oldOrganization': 'Odense University Hospital, Denmark'}}}}