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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 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: June 16, 2016
Last verified: June 2016

August 19, 2010
June 16, 2016
January 2009
December 2025   (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 and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • target-lesion and target-vessel revascularization [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • procedural success [ Time Frame: at 1 day ] [ Designated as safety issue: Yes ]
  • 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 ]
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-,second-,third-, and fourth-generation DES, in the "real world" daily practice.
Consecutive patients receiving New DES without a mixture of other DES
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
consecutive patients amenable to PCI
  • Coronary Artery Disease
  • Percutaneous Transluminal Coronary Angioplasty
Not Provided
  • DESSIAN
    consecutive patients receiving CYPHER stent
  • K-XIENCE
    consecutive patients receiving Xience stent
  • GENOUS
    consecutive patients receiving GENOUS stent
  • ELEMENT
    consecutive patients receiving PROMUS-ELEMENT stent
  • PRIME
    consecutive patients receiving XIENCE-PRIME stent
  • NOBORI
    consecutive patients receiving NOBORI stent
  • INTEGRITY
    consecutive patients receiving RESOLUTE-INTEGRITY stent
  • XPEDITION
    consecutive patients receiving XIENCE-XPEDITION stent
  • BIOMATRIX
    consecutive patients receiving BIOMATRIX stent
  • CILOTAX
    consecutive patients receiving CILOTAX stent
  • DEB
    consecutive patients receiving Drug eluting balloon
  • DESYNE
    consecutive patients receiving DESYNE stent
  • PREMIER
    consecutive patients receiving PROMUS-PREMIER stent
  • ORSIRO
    consecutive patients receiving ORSIRO stent
  • ONYX
    consecutive patients receiving ONYX stent
  • BVS
    consecutive patients receiving Bioresorbable Vascular Scaffold
  • BVS AMI
    consecutive acute myocardial infarction patients receiving Bioresorbable Vascular Scaffold
  • Ultimaster
    consecutive patients receiving Ultimaster stent
  • Synergy
    consecutive patients receiving Synergy stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25000
December 2025
December 2025   (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   (Adult, Senior)
No
Contact: Seung-Jung Park, MD sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD dwpark@amc.seoul.kr
Korea, Republic of
 
NCT01186133
2010-035
Yes
No
This is not a publicly funded trial.
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Study Chair: Seung-Jung Park, MD Asan Medical Center
CardioVascular Research Foundation, Korea
June 2016

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