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Completed

NCT Number: NCT00989066

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.

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Key information

Conditions

Arterial Coronary Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIAS Unimed Vitória, Vitória, Espírito Santo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up

    Time frame: 12 months

Secondary outcomes

  1. Rates of procedural success

    Time frame: 24 months

  2. MACE at in-hospital

    Time frame: 30 days, 6 months, and 24 months

  3. Toll-like receptor (TLR)

    Time frame: at 6 and 12 months

  4. Stent thrombosis up to 24 mo

    Time frame: up to 24 months

  5. Dual anti-platelet therapy compliance

    Time frame: at 1, 6 and 12 months

  6. Major bleeding events

    Time frame: at 1, 6 and 12 mo

Sponsors and collaborators

Lead sponsor

Cardiovascular Research Center, Brazil

Other

Registry information

Acronym: BRAVO

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Oct 2, 2009
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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