Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-02 @ 8:51 AM
Study NCT ID:
NCT00989066
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-26', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Rates of procedural success', 'timeFrame': '24 months'}, {'measure': 'MACE at in-hospital', 'timeFrame': '30 days, 6 months, and 24 months'}, {'measure': 'Toll-like receptor (TLR)', 'timeFrame': 'at 6 and 12 months'}, {'measure': 'Stent thrombosis up to 24 mo', 'timeFrame': 'up to 24 months'}, {'measure': 'Dual anti-platelet therapy compliance', 'timeFrame': 'at 1, 6 and 12 months'}, {'measure': 'Major bleeding events', 'timeFrame': 'at 1, 6 and 12 mo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Xience V', 'stent', 'coronary disease'], 'conditions': ['Arterial Coronary Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the performance and long-term clinical outcomes of the Xience V everolimus-eluting coronary stent system (EECSS) in the treatment of minimally selective, high risk patients in the real-world clinical practice.', 'detailedDescription': 'Prospective, multicenter, non-randomized, post-marketing web-based registry.Patients all comers assigned for percutaneous coronary intervention (PCI) who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Xience V EECSS only can be included on this Registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients all comers assigned for percutaneous coronary intervention who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Xience V', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years of age; clinical indication for elective or emergency PCI with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups\n* Diseased coronary vessel(s) with the presence of at least one obstruction \\>50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with anatomy suitable for percutaneous treatment with implantation of the Xience V EECSS\n\nExclusion Criteria:\n\n* Known illness with life expectancy \\<24 months; impossibility to comply with all protocol follow-ups\n* Coronary anatomy unsuitable for percutaneous treatment with implantation of the Xience V EECSS'}, 'identificationModule': {'nctId': 'NCT00989066', 'acronym': 'BRAVO', 'briefTitle': 'Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular Research Center, Brazil'}, 'officialTitle': 'Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry', 'orgStudyIdInfo': {'id': 'BRA01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'CIAS Unimed Vitória', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Encore', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Lifecenter', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Mater Dei', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Nova Lima', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Madre Tereza', 'geoPoint': {'lat': -19.98556, 'lon': -43.84667}}, {'city': 'Uberlândia', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Instituto do Coração do Triângulo Mineiro', 'geoPoint': {'lat': -18.91861, 'lon': -48.27722}}, {'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Cardiológico Costantini', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Instituto de Neurologia de Curitiba', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Belém', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Centro Interado de Medicina Intervencionista', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}, {'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Maximagem', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Jacarepaguá', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hemocor', 'geoPoint': {'lat': -22.96675, 'lon': -43.38532}}, {'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Barra DOr', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Copa DOr', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Quinta DOr', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital São Vicente de Paulo', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Fundação Universitária de Cardiologia', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital São Lucas da PUC', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Santa Casa de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Bandeirantes', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Beneficência Portuguesa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coração', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Alexandre Abizaid, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Research Center, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}