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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier:
NCT00989066
First received: October 1, 2009
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition
Arterial Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Center, Brazil:

Primary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rates of procedural success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • MACE at in-hospital [ Time Frame: 30 days, 6 months, and 24 months ] [ Designated as safety issue: Yes ]
  • Toll-like receptor (TLR) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis up to 24 mo [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Dual anti-platelet therapy compliance [ Time Frame: at 1, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Major bleeding events [ Time Frame: at 1, 6 and 12 mo ] [ Designated as safety issue: Yes ]

Enrollment: 535
Study Start Date: September 2008
Study Completion Date: November 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989066

Locations
Brazil
CIAS Unimed Vitória
Vitória, ES, Brazil
Encore
Goiânia, GO, Brazil
Hospital Lifecenter
Belo Horizonte, MG, Brazil
Hospital Mater Dei
Belo Horizonte, MG, Brazil
Hospital Madre Tereza
Nova Lima, MG, Brazil
Instituto do Coração do Triângulo Mineiro
Uberlândia, MG, Brazil
Centro Interado de Medicina Intervencionista
Belém, Pará, Brazil
Maximagem
Recife, PE, Brazil
Hospital Cardiológico Costantini
Curitiba, PR, Brazil
Instituto de Neurologia de Curitiba
Curitiba, PR, Brazil
Hemocor
Jacarepagua, RJ, Brazil
Barra DOr
Rio de Janeiro, RJ, Brazil
Hospital Quinta DOr
Rio de Janeiro, RJ, Brazil
Hospital Copa DOr
Rio de Janeiro, RJ, Brazil
Hospital São Vicente de Paulo
Passo Fundo, RS, Brazil
Hospital Moinhos de Vento
Porto Alegre, RS, Brazil
Hospital São Lucas da PUC
Porto Alegre, RS, Brazil
Fundação Universitária de Cardiologia
Porto Alegre, RS, Brazil
Santa Casa de Porto Alegre
Porto Alegre, RS, Brazil
Hospital Beneficência Portuguesa
São Paulo, SP, Brazil
Hospital do Coração
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
Sponsors and Collaborators
Cardiovascular Research Center, Brazil
Investigators
Principal Investigator: Alexandre Abizaid, MD, PhD Cardiovascular Research Center
  More Information

No publications provided

Responsible Party: Cardiovascular Research Center, Brazil
ClinicalTrials.gov Identifier: NCT00989066     History of Changes
Other Study ID Numbers: BRA01
Study First Received: October 1, 2009
Last Updated: November 26, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Cardiovascular Research Center, Brazil:
Xience V
stent
coronary disease

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014