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NCT01788592 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official title:
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01788592
Other study ID # AMCCV2013-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2003
Est. completion date October 2030

Study information
Verified date June 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50000
Est. completion date October 2030
Est. primary completion date October 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seung-Jung Park

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiac Event Death from any causes, myocardial infarction or any repeat revascularization 1year
Secondary all cause Death 1year
Secondary Myocardial Infarction 1year
Secondary The composite of Death or myocardial infarction 1year
Secondary Any repeat revascularization 1year
Secondary Target vessel revascularization 1year
Secondary Target lesion revascularization 1year
Secondary New lesion revascularization 1year
Secondary Stent thrombosis by Academic Research Consortium criteria 1year
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