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Recruiting NCT01788592

Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)

Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice

Overview

The objective of this study is to evaluate effectiveness and safety of drug-eluting stent implantation in the "real world" daily practice.

Primary outcome measures

  • Major Adverse Cardiac Event [Time frame: 1year]
Secondary outcome measures (8)
  • all cause Death [Time frame: 1year]
  • Myocardial Infarction [Time frame: 1year]
  • The composite of Death or myocardial infarction [Time frame: 1year]
  • Any repeat revascularization [Time frame: 1year]
  • Target vessel revascularization [Time frame: 1year]
  • Target lesion revascularization [Time frame: 1year]
  • New lesion revascularization [Time frame: 1year]
  • Stent thrombosis by Academic Research Consortium criteria [Time frame: 1year]

Eligibility criteria

Inclusion criteria

  • coronary disease amenable to percutaneous coronary intervention (PCI)
  • no clinical and lesion limitations

Exclusion criteria

  • patients with a mixture of several drug eluting stents
  • terminal illness with life expectancy less than 1 year
  • patients with cardiogenic shock

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Publications

  • Park SJ, Ahn JM, Park GM, Cho YR, Lee JY, Kim WJ, Han S, Kang SJ, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW. Trends in the outcomes of percutaneous coronary intervention with the routine incorporation of fractional flow reserve in real practice. Eur Heart J. 2013 Nov;34(43):3353-61. doi: 10.1093/eurheartj/eht404. Epub 2013 Oct 2. PMID 24092248

Identifiers

NCT: NCT01788592 · AMCCV2013-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗