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

This study is currently recruiting participants.
Verified December 2016 by Seung-Jung Park, CardioVascular Research Foundation, Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186133
First Posted: August 23, 2010
Last Update Posted: December 22, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
August 19, 2010
August 23, 2010
December 22, 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 ]
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 ]
  • myocardial infarction [ Time Frame: at 12 months and annually up to 5 years ]
  • stent thrombosis [ Time Frame: at 12 months and annually up to 5 years ]
  • target-lesion and target-vessel revascularization [ Time Frame: at 12 months and annually up to 5 years ]
  • procedural success [ Time Frame: at 1 day ]
  • death (all-cause and cardiac) [ Time Frame: at 12 months ]
  • myocardial infarction [ Time Frame: at 12 months ]
  • stent thrombosis [ Time Frame: at 12 months ]
  • target-lesion and target-vessel revascularization [ Time Frame: at 12 months ]
  • procedural success [ Time Frame: at 1 day ]
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
Sexes Eligible for Study: All
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
Not Provided
Plan to Share IPD: No
Plan Description: 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
December 2016