Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice (IRIS-DES)

This study is currently recruiting participants.
Verified November 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01186133
First received: August 19, 2010
Last updated: November 22, 2012
Last verified: November 2012

August 19, 2010
November 22, 2012
January 2009
December 2015   (final data collection date for primary outcome measure)
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01186133 on ClinicalTrials.gov Archive Site
  • death (all-cause and cardiac) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • target-lesion and target-vessel revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • procedural success [ Time Frame: at 1 day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first- and second-generation DES, in the "real world" daily practice.

evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first- and second-generation DES, in the "real world" daily practice.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

consecutive patients amenable to PCI

Coronary Artery Disease
Not Provided
  • Cypher stent group (DESSIAN registry)
    consecutive patients receiving cypher stent
  • Xience stent group (K-Xience registry)
    consecutive patients receiving Xience stent
  • Nobori stent group
    consecutive patients receiving Nobori stent
  • PROMUS ELEMENT group
    consecutive patients receiving Promus element stent
  • Biomatrix stent group
    consecutive patients receiving Biomatrix stent
  • Genous stent group
    STEMI patients receiving Genous stent
  • IRIS-PRIME group
    consecutive patients receiving XIENCE-PRIME stent
  • IRIS-RESOLUTE group
    consecutive patients receiving Resolute-Integrity stent
  • IRIS-CILOTAX group
    consecutive patients receiving cilotax stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18600
December 2018
December 2015   (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 DES
  • terminal illness with life expectancy less than 1 year
  • patients with cardiogenic shock
Both
18 Years and older
No
Contact: Seung-Jung Park, MD, PhD 2-3010-4812 ext 82 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 2-3010-3995 ext 82 dwpark@amc.seoul.kr
Korea, Republic of
 
NCT01186133
2010-035
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park Asan Medical Center
CardioVascular Research Foundation, Korea
November 2012

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