Arterial Coronary Disease Clinical Trial
— BRAVOOfficial title:
Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
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.
| Status | Completed |
| Enrollment | 535 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 - 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 Exclusion Criteria: - Known illness with life expectancy <24 months; impossibility to comply with all protocol follow-ups - Coronary anatomy unsuitable for percutaneous treatment with implantation of the Xience V EECSS |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Centro Interado de Medicina Intervencionista | Belém | Pará |
| Brazil | Hospital Lifecenter | Belo Horizonte | MG |
| Brazil | Hospital Mater Dei | Belo Horizonte | MG |
| Brazil | Hospital Cardiológico Costantini | Curitiba | PR |
| Brazil | Instituto de Neurologia de Curitiba | Curitiba | PR |
| Brazil | Encore | Goiânia | GO |
| Brazil | Hemocor | Jacarepagua | RJ |
| Brazil | Hospital Madre Tereza | Nova Lima | MG |
| Brazil | Hospital São Vicente de Paulo | Passo Fundo | RS |
| Brazil | Fundação Universitária de Cardiologia | Porto Alegre | RS |
| Brazil | Hospital Moinhos de Vento | Porto Alegre | RS |
| Brazil | Hospital São Lucas da PUC | Porto Alegre | RS |
| Brazil | Santa Casa de Porto Alegre | Porto Alegre | RS |
| Brazil | Maximagem | Recife | PE |
| Brazil | Barra DOr | Rio de Janeiro | RJ |
| Brazil | Hospital Copa DOr | Rio de Janeiro | RJ |
| Brazil | Hospital Quinta DOr | Rio de Janeiro | RJ |
| Brazil | Hospital Albert Einstein | São Paulo | SP |
| Brazil | Hospital Bandeirantes | São Paulo | SP |
| Brazil | Hospital Beneficência Portuguesa | São Paulo | SP |
| Brazil | Hospital do Coração | São Paulo | SP |
| Brazil | Instituto Dante Pazzanese de Cardiologia | São Paulo | SP |
| Brazil | Instituto do Coração do Triângulo Mineiro | Uberlândia | MG |
| Brazil | CIAS Unimed Vitória | Vitória | ES |
| Lead Sponsor | Collaborator |
|---|---|
| Cardiovascular Research Center, Brazil |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up | 12 months | Yes | |
| Secondary | Rates of procedural success | 24 months | Yes | |
| Secondary | MACE at in-hospital | 30 days, 6 months, and 24 months | Yes | |
| Secondary | Toll-like receptor (TLR) | at 6 and 12 months | Yes | |
| Secondary | Stent thrombosis up to 24 mo | up to 24 months | Yes | |
| Secondary | Dual anti-platelet therapy compliance | at 1, 6 and 12 months | Yes | |
| Secondary | Major bleeding events | at 1, 6 and 12 mo | Yes |