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Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry

NCT ID: NCT00989066

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Arterial Coronary Disease

Keywords

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Xience V stent coronary disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovascular Research Center, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Abizaid, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Research Center

Locations

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CIAS Unimed Vitória

Vitória, Espírito Santo, Brazil

Site Status

Encore

Goiânia, Goiás, Brazil

Site Status

Hospital Lifecenter

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital Mater Dei

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital Madre Tereza

Nova Lima, Minas Gerais, Brazil

Site Status

Instituto do Coração do Triângulo Mineiro

Uberlândia, Minas Gerais, Brazil

Site Status

Hospital Cardiológico Costantini

Curitiba, Paraná, Brazil

Site Status

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Site Status

Centro Interado de Medicina Intervencionista

Belém, Pará, Brazil

Site Status

Maximagem

Recife, Pernambuco, Brazil

Site Status

Hemocor

Jacarepaguá, Rio de Janeiro, Brazil

Site Status

Barra DOr

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital Copa DOr

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital Quinta DOr

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Site Status

Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital São Lucas da PUC

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Albert Einstein

São Paulo, São Paulo, Brazil

Site Status

Hospital Bandeirantes

São Paulo, São Paulo, Brazil

Site Status

Hospital Beneficência Portuguesa

São Paulo, São Paulo, Brazil

Site Status

Hospital do Coração

São Paulo, São Paulo, Brazil

Site Status

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BRA01

Identifier Type: -

Identifier Source: org_study_id