NCT01788592

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress84%
Jan 2003Oct 2030

Study Start

First participant enrolled

January 1, 2003

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
17.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

27.8 years

First QC Date

February 8, 2013

Last Update Submit

December 28, 2025

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasedrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Event

    Death from any causes, myocardial infarction or any repeat revascularization

    1year

Secondary Outcomes (8)

  • all cause Death

    1year

  • Myocardial Infarction

    1year

  • The composite of Death or myocardial infarction

    1year

  • Any repeat revascularization

    1year

  • Target vessel revascularization

    1year

  • +3 more secondary outcomes

Study Arms (1)

Drug eluting stent

Patients who receiving drug eluting stents

Eligibility Criteria

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

consecutive patients amenable to percutaneous coronary intervention with drug eluting stents

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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: 24092248DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Seung-Jung Park, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 11, 2013

Study Start

January 1, 2003

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

KR(1)