Clinical trial NCT00989066: Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
Official title: Brazil Xience V Everolimus-Eluting Coronary Stent System "Real-World" Outcomes Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Coronary Disease
Keywords: Xience V
stent
coronary disease
Lead sponsor: Cardiovascular Research Center, Brazil
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Rates of procedural success
timeFrame: 24 months
measure: MACE at in-hospital
timeFrame: 30 days, 6 months, and 24 months
measure: Toll-like receptor (TLR)
timeFrame: at 6 and 12 months
measure: Stent thrombosis up to 24 mo
timeFrame: up to 24 months
measure: Dual anti-platelet therapy compliance
timeFrame: at 1, 6 and 12 months
measure: Major bleeding events
timeFrame: at 1, 6 and 12 mo
Other outcomes:
Locations:
city: Vitória
country: Brazil
facility: CIAS Unimed Vitória
state: ES
city: Goiânia
country: Brazil
facility: Encore
state: GO
city: Belo Horizonte
country: Brazil
facility: Hospital Lifecenter
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Mater Dei
state: MG
city: Nova Lima
country: Brazil
facility: Hospital Madre Tereza
state: MG
city: Uberlândia
country: Brazil
facility: Instituto do Coração do Triângulo Mineiro
state: MG
city: Belém
country: Brazil
facility: Centro Interado de Medicina Intervencionista
state: Pará
city: Recife
country: Brazil
facility: Maximagem
state: PE
city: Curitiba
country: Brazil
facility: Hospital Cardiológico Costantini
state: PR
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: PR
city: Jacarepagua
country: Brazil
facility: Hemocor
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Barra DOr
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Copa DOr
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Quinta DOr
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: RS
city: Porto Alegre
country: Brazil
facility: Fundação Universitária de Cardiologia
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUC
state: RS
city: Porto Alegre
country: Brazil
facility: Santa Casa de Porto Alegre
state: RS
city: São Paulo
country: Brazil
facility: Hospital Albert Einstein
state: SP
city: São Paulo
country: Brazil
facility: Hospital Bandeirantes
state: SP
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
Study officials:
affiliation: Cardiovascular Research Center
name: Alexandre Abizaid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: