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

This study is currently recruiting participants.
Verified February 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01788592
First received: February 8, 2013
Last updated: February 26, 2013
Last verified: February 2013

February 8, 2013
February 26, 2013
January 2003
December 2014   (final data collection date for primary outcome measure)
Major Adverse Cardiac Event [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
Death from any causes, myocardial infarction or any repeat revascularization
Same as current
Complete list of historical versions of study NCT01788592 on ClinicalTrials.gov Archive Site
  • all cause Death [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
  • The composite of Death or myocardial infarction [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
  • Any repeat revascularization [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • New lesion revascularization [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Stent thrombosis by Academic Research Consortium criteria [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice

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

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample

consecutive patients amenable to percutaneous coronary intervention with drug eluting stents

Coronary Artery Disease
Not Provided
Drug eluting stent
Patients who receiving drug eluting stents
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Korea, Republic of
 
NCT01788592
AMCCV2013-02
No
Seung-Jung Park, Asan Medical Center
Seung-Jung Park
Not Provided
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
Asan Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP