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

Sponsor
Seung-Jung Park (Other)
Overall Status
Recruiting
CT.gov ID
NCT01788592
Collaborator
(none)
50,000
Enrollment
1
Location
333
Anticipated Duration (Months)
150.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice
    Actual Study Start Date :
    Jan 1, 2003
    Anticipated Primary Completion Date :
    Oct 1, 2030
    Anticipated Study Completion Date :
    Oct 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Drug eluting stent

    Patients who receiving drug eluting stents

    Outcome Measures

    Primary Outcome Measures

    1. Major Adverse Cardiac Event [1year]

      Death from any causes, myocardial infarction or any repeat revascularization

    Secondary Outcome Measures

    1. all cause Death [1year]

    2. Myocardial Infarction [1year]

    3. The composite of Death or myocardial infarction [1year]

    4. Any repeat revascularization [1year]

    5. Target vessel revascularization [1year]

    6. Target lesion revascularization [1year]

    7. New lesion revascularization [1year]

    8. Stent thrombosis by Academic Research Consortium criteria [1year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seung-Jung Park

    Investigators

    • Principal Investigator: Seung-Jung Park, MD, PhD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT01788592
    Other Study ID Numbers:
    • AMCCV2013-02
    First Posted:
    Feb 11, 2013
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, Asan Medical Center
    coronary artery disease
    drug eluting stent
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease

    Study Results

    No Results Posted as of Feb 16, 2022