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

November 26, 2012 updated by: Cardiovascular Research Center, Brazil
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • ES
      • Vitória, ES, Brazil
        • CIAS Unimed Vitória
    • GO
      • Goiânia, GO, Brazil
        • ENCORE
    • MG
      • Belo Horizonte, MG, Brazil
        • Hospital Lifecenter
      • Belo Horizonte, MG, Brazil
        • Hospital Mater Dei
      • Nova Lima, MG, Brazil
        • Hospital Madre Tereza
      • Uberlândia, MG, Brazil
        • Instituto do Coração do Triângulo Mineiro
    • PE
      • Recife, PE, Brazil
        • Maximagem
    • PR
      • Curitiba, PR, Brazil
        • Hospital Cardiologico Costantini
      • Curitiba, PR, Brazil
        • Instituto de Neurologia de Curitiba
    • Pará
      • Belém, Pará, Brazil
        • Centro Interado de Medicina Intervencionista
    • RJ
      • Jacarepagua, RJ, Brazil
        • Hemocor
      • Rio de Janeiro, RJ, Brazil
        • Barra DOr
      • Rio de Janeiro, RJ, Brazil
        • Hospital Copa DOr
      • Rio de Janeiro, RJ, Brazil
        • Hospital Quinta DOr
    • RS
      • Passo Fundo, RS, Brazil
        • Hospital Sao Vicente de Paulo
      • Porto Alegre, RS, Brazil
        • Fundacao Universitaria 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
    • SP
      • São Paulo, SP, Brazil
        • Hospital Albert Einstein
      • São Paulo, SP, Brazil
        • Hospital Bandeirantes
      • São Paulo, SP, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, SP, Brazil
        • Hospital Beneficencia Portuguesa
      • São Paulo, SP, Brazil
        • Hospital do Coração

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of procedural success
Time Frame: 24 months
24 months
MACE at in-hospital
Time Frame: 30 days, 6 months, and 24 months
30 days, 6 months, and 24 months
Toll-like receptor (TLR)
Time Frame: at 6 and 12 months
at 6 and 12 months
Stent thrombosis up to 24 mo
Time Frame: up to 24 months
up to 24 months
Dual anti-platelet therapy compliance
Time Frame: at 1, 6 and 12 months
at 1, 6 and 12 months
Major bleeding events
Time Frame: at 1, 6 and 12 mo
at 1, 6 and 12 mo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Research Center, Brazil

Investigators

  • Principal Investigator: Alexandre Abizaid, MD, PhD, Cardiovascular Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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