NCT00989066
Completed
Not Applicable
Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
Cardiovascular Research Center, Brazil24 sites in 1 country535 target enrollmentSeptember 2008
ConditionsArterial Coronary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arterial Coronary Disease
- Sponsor
- Cardiovascular Research Center, Brazil
- Enrollment
- 535
- Locations
- 24
- Primary Endpoint
- Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
Time Frame: 12 months
Secondary Outcomes
- Rates of procedural success(24 months)
- MACE at in-hospital(30 days, 6 months, and 24 months)
- Toll-like receptor (TLR)(at 6 and 12 months)
- Stent thrombosis up to 24 mo(up to 24 months)
- Dual anti-platelet therapy compliance(at 1, 6 and 12 months)
- Major bleeding events(at 1, 6 and 12 mo)
Study Sites (24)
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