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
  Purpose

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


Condition
Coronary Artery Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Major Adverse Cardiac Event [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
    Death from any causes, myocardial infarction or any repeat revascularization


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20000
Study Start Date: January 2003
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Drug eluting stent
Patients who receiving drug eluting stents

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

consecutive patients amenable to percutaneous coronary intervention with drug eluting stents

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788592

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park, MD,PhD    82-2-3010-4812    sjpark@amc.seoul.kr   
Contact: Jung-Min Ahn, MD    82-2-3010-5904    drjmahn@gmail.com   
Principal Investigator: Seung-Jung Park, MD,PhD         
Sub-Investigator: Jung-Min Ahn, MD         
Sponsors and Collaborators
Seung-Jung Park
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT01788592     History of Changes
Other Study ID Numbers: AMCCV2013-02
Study First Received: February 8, 2013
Last Updated: February 26, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
coronary artery disease
drug eluting stent

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

ClinicalTrials.gov processed this record on April 16, 2014