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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00989066

Acronym

BRAVO

Enrollment

535

Registered

2009-10-02

Start date

2008-09-30

Completion date

2012-11-30

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Coronary Disease

Keywords

Xience V, stent, coronary disease

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results