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

This study is currently recruiting participants. (see Contacts and Locations)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014