Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
- Conditions
- Arterial Coronary Disease
- Registration Number
- NCT00989066
- Lead Sponsor
- Cardiovascular Research Center, Brazil
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up 12 months
- Secondary Outcome Measures
Name Time Method Rates of procedural success 24 months MACE at in-hospital 30 days, 6 months, and 24 months Toll-like receptor (TLR) at 6 and 12 months Stent thrombosis up to 24 mo up to 24 months Dual anti-platelet therapy compliance at 1, 6 and 12 months Major bleeding events at 1, 6 and 12 mo
Trial Locations
- Locations (24)
Hemocor
🇧🇷Jacarepagua, RJ, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, RS, Brazil
CIAS Unimed Vitória
🇧🇷Vitória, ES, Brazil
Encore
🇧🇷Goiânia, GO, Brazil
Hospital Lifecenter
🇧🇷Belo Horizonte, MG, Brazil
Instituto do Coração do Triângulo Mineiro
🇧🇷Uberlândia, MG, Brazil
Hospital Madre Tereza
🇧🇷Nova Lima, MG, Brazil
Hospital Mater Dei
🇧🇷Belo Horizonte, MG, Brazil
Hospital Cardiológico Costantini
🇧🇷Curitiba, PR, Brazil
Maximagem
🇧🇷Recife, PE, Brazil
Instituto de Neurologia de Curitiba
🇧🇷Curitiba, PR, Brazil
Hospital Copa DOr
🇧🇷Rio de Janeiro, RJ, Brazil
Barra DOr
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Quinta DOr
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Bandeirantes
🇧🇷São Paulo, SP, Brazil
Santa Casa de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital Albert Einstein
🇧🇷São Paulo, SP, Brazil
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, RS, Brazil
Fundação Universitária de Cardiologia
🇧🇷Porto Alegre, RS, Brazil
Hospital São Lucas da PUC
🇧🇷Porto Alegre, RS, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷São Paulo, SP, Brazil
Hospital Beneficência Portuguesa
🇧🇷São Paulo, SP, Brazil
Hospital do Coração
🇧🇷São Paulo, SP, Brazil
Centro Interado de Medicina Intervencionista
🇧🇷Belém, Pará, Brazil