NCT00989066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

3.2 years

First QC Date

October 1, 2009

Last Update Submit

November 26, 2012

Conditions

Arterial Coronary Disease

Keywords

Xience Vstentcoronary disease

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up

    12 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

CIAS Unimed Vitória

Vitória, Espírito Santo, Brazil

Location

Encore

Goiânia, Goiás, Brazil

Location

Hospital Lifecenter

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Mater Dei

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Madre Tereza

Nova Lima, Minas Gerais, Brazil

Location

Instituto do Coração do Triângulo Mineiro

Uberlândia, Minas Gerais, Brazil

Location

Hospital Cardiológico Costantini

Curitiba, Paraná, Brazil

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Location

Centro Interado de Medicina Intervencionista

Belém, Pará, Brazil

Location

Maximagem

Recife, Pernambuco, Brazil

Location

Hemocor

Jacarepaguá, Rio de Janeiro, Brazil

Location

Barra DOr

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Copa DOr

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Quinta DOr

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital São Lucas da PUC

Porto Alegre, Rio Grande do Sul, Brazil

Location

Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Albert Einstein

São Paulo, São Paulo, Brazil

Location

Hospital Bandeirantes

São Paulo, São Paulo, Brazil

Location

Hospital Beneficência Portuguesa

São Paulo, São Paulo, Brazil

Location

Hospital do Coração

São Paulo, São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Alexandre Abizaid, MD, PhD

    Cardiovascular Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

September 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

BR(24)