Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-29 @ 4:23 AM
Study NCT ID:
NCT00818792
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2009-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2009-01-07', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemia-driven target vessel revascularization', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of death and myocardial infarction', 'timeFrame': 'in-hospital, 30 days, 9 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Drug-eluting stent', 'Chronic kidney disease', 'Restenosis'], 'conditions': ['Chronic Kidney Disease', 'Multivessel Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '17606856', 'type': 'BACKGROUND', 'citation': 'Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. doi: 10.1161/CIRCULATIONAHA.106.678342.'}, {'pmid': '17909090', 'type': 'BACKGROUND', 'citation': 'Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffre G, Prati F, Tamburino C, Ribichini F. Head-to-head comparison of sirolimus- and paclitaxel-eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study. Diabetes Care. 2008 Jan;31(1):15-9. doi: 10.2337/dc07-1377. Epub 2007 Oct 1.'}, {'pmid': '24357403', 'type': 'DERIVED', 'citation': 'Tomai F, Ribichini F, De Luca L, Petrolini A, Ghini AS, Weltert L, Spaccarotella C, Proietti I, Trani C, Nudi F, Pighi M, Vassanelli C. Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study. Circulation. 2014 Mar 11;129(10):1104-12. doi: 10.1161/CIRCULATIONAHA.113.005186. Epub 2013 Dec 19.'}, {'pmid': '19924001', 'type': 'DERIVED', 'citation': 'Tomai F, Petrolini A, De Luca L, Nudi F, Lanza G, Vassanelli C, Ribichini F. Rationale and design of the Randomized comparison of XiEnce V and Multilink VisioN coronary stents in the sAme muLtivessel patient with chronic kiDnEy disease (RENAL-DES) study. J Cardiovasc Med (Hagerstown). 2010 Apr;11(4):310-7. doi: 10.2459/JCM.0b013e3283347e24.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might reduce the incidence of restenosis and therefore of target lesion revascularization procedures in these patients.\n\nWe therefore designed a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively), both implanted in the same patient with multivessel disease and renal insufficiency in order to obviate for the multiple and unpredictable characteristics of this high-risk population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic renal insufficiency (creatinine clearance \\<60 ml/min, in dialysis patients included) with at least two significant (\\>70%) coronary lesions in two major coronary vessels.\n\nExclusion Criteria:\n\n* Age \\>85 years\n* left main coronary artery disease\n* saphenous vein graft disease\n* ST-elevation MI (\\<3 days)\n* coronary vessel diameter \\<2.5 or \\> 4 mm\n* contraindication to long-term double antiplatelet therapy\n* CABG indication by consensus (cardiovascular team)\n* severe valvular heart disease\n* informed consent not obtained'}, 'identificationModule': {'nctId': 'NCT00818792', 'acronym': 'RENAL-DES', 'briefTitle': 'Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease', 'organization': {'class': 'OTHER', 'fullName': 'European Hospital'}, 'officialTitle': 'A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'RENAL-DES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug-eluting stent Xience V', 'interventionNames': ['Device: Coronary stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bare-metal stent Vision', 'interventionNames': ['Device: Coronary stent']}], 'interventions': [{'name': 'Coronary stent', 'type': 'DEVICE', 'otherNames': ['Bare metal stent Vision', 'Drug-eluting stent Xience V'], 'description': 'Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)', 'armGroupLabels': ['Bare-metal stent Vision', 'Drug-eluting stent Xience V']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00149', 'city': 'Rome', 'country': 'Italy', 'facility': 'European Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Istituti Ospitalieri di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Fabrizio Tomai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Sciences, European Hospital, Rome'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FACC, FESC', 'investigatorFullName': 'Fabrizio Tomai', 'investigatorAffiliation': 'European Hospital'}}}}