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

October 1, 2009
November 26, 2012
September 2008
November 2011   (final data collection date for primary outcome measure)
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00989066 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Arterial Coronary Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
November 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00989066
BRA01
Yes
Cardiovascular Research Center, Brazil
Cardiovascular Research Center, Brazil
Not Provided
Principal Investigator: Alexandre Abizaid, MD, PhD Cardiovascular Research Center
Cardiovascular Research Center, Brazil
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP