Arterial Coronary DiseaseBRAVONCT00989066
Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
An observational study of Arterial Coronary Disease, run by Cardiovascular Research Center, Brazil at 24 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Coronary Disease
- How many people
- 535 participants
- Where
- 24 sitesBrazil
- Study dates
- Sep 2008to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Brazil24 sites
Centro Interado de Medicina Intervencionista
Belém, Pará
Hospital Lifecenter
Belo Horizonte, Minas Gerais
Hospital Mater Dei
Belo Horizonte, Minas Gerais
Hospital Cardiológico Costantini
Curitiba, Paraná
Instituto de Neurologia de Curitiba
Curitiba, Paraná
Encore
Goiânia, Goiás
Hemocor
Jacarepaguá, Rio de Janeiro
Hospital Madre Tereza
Nova Lima, Minas Gerais
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul
Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul
Hospital São Lucas da PUC
Porto Alegre, Rio Grande do Sul
Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul
Maximagem
Recife, Pernambuco
Barra DOr
Rio de Janeiro, Rio de Janeiro
Hospital Copa DOr
Rio de Janeiro, Rio de Janeiro
Hospital Quinta DOr
Rio de Janeiro, Rio de Janeiro
Hospital Albert Einstein
São Paulo, São Paulo
Hospital Bandeirantes
São Paulo, São Paulo
Hospital Beneficência Portuguesa
São Paulo, São Paulo
Hospital do Coração
São Paulo, São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo
Instituto do Coração do Triângulo Mineiro
Uberlândia, Minas Gerais
CIAS Unimed Vitória
Vitória, Espírito Santo
About this study
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.
Read the 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.
- Conditions
- Arterial Coronary Disease
- Keywords
- Xience V, stent, coronary disease
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
Measured: 12 months
Secondary outcomes (6)
Rates of procedural success
Measured: 24 months
MACE at in-hospital
Measured: 30 days, 6 months, and 24 months
Toll-like receptor (TLR)
Measured: at 6 and 12 months
Stent thrombosis up to 24 mo
Measured: up to 24 months
Dual anti-platelet therapy compliance
Measured: at 1, 6 and 12 months
Major bleeding events
Measured: at 1, 6 and 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Center, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Abizaid, MD, PhD, Principal investigator, Cardiovascular Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989066
- Sponsor's protocol ID
- BRA01
- Acronym
- BRAVO
- Status last verified
- Nov 2012
- First submitted
- 1 Oct 2009
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
- ClinicalTrials.gov ID
- NCT00989066
- Acronym / sponsor ID
- BRAVO / BRA01
- Conditions
- Arterial Coronary Disease
- Keywords
- Xience V, stent, coronary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Cardiovascular Research Center, BrazilUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
Time frame: 12 months
6 secondary outcomes
Rates of procedural success
Time frame: 24 months
MACE at in-hospital
Time frame: 30 days, 6 months, and 24 months
Toll-like receptor (TLR)
Time frame: at 6 and 12 months
Stent thrombosis up to 24 mo
Time frame: up to 24 months
Dual anti-platelet therapy compliance
Time frame: at 1, 6 and 12 months
Major bleeding events
Time frame: at 1, 6 and 12 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Abizaid, MD, PhD principal investigator
Cardiovascular Research Center
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Coronary Disease, run by Cardiovascular Research Center, Brazil at 24 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.