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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01788592
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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
Coronary Artery Disease

Study Type : Observational [Patient Registry]
Actual Enrollment : 5097 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice
Study Start Date : January 2003
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Drug eluting stent
Patients who receiving drug eluting stents

Primary Outcome Measures :
  1. Major Adverse Cardiac Event [ Time Frame: 1year ]
    Death from any causes, myocardial infarction or any repeat revascularization

Secondary Outcome Measures :
  1. all cause Death [ Time Frame: 1year ]
  2. Myocardial Infarction [ Time Frame: 1year ]
  3. The composite of Death or myocardial infarction [ Time Frame: 1year ]
  4. Any repeat revascularization [ Time Frame: 1year ]
  5. Target vessel revascularization [ Time Frame: 1year ]
  6. Target lesion revascularization [ Time Frame: 1year ]
  7. New lesion revascularization [ Time Frame: 1year ]
  8. Stent thrombosis by Academic Research Consortium criteria [ Time Frame: 1year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients amenable to percutaneous coronary intervention with drug eluting stents

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01788592

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, Asan Medical Center Identifier: NCT01788592     History of Changes
Other Study ID Numbers: AMCCV2013-02
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Seung-Jung Park, Asan Medical Center:
coronary artery disease
drug eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases