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

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. Identifier: NCT01186133
Recruitment Status : Recruiting
First Posted : August 23, 2010
Last Update Posted : January 4, 2019
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:
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.

Condition or disease
Coronary Artery Disease Percutaneous Transluminal Coronary Angioplasty

Detailed Description:
Consecutive patients receiving New DES without a mixture of other DES

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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
Study Start Date : January 2009
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

consecutive patients receiving CYPHER stent
consecutive patients receiving Xience stent
consecutive patients receiving GENOUS stent
consecutive patients receiving PROMUS-ELEMENT stent
consecutive patients receiving XIENCE-PRIME stent
consecutive patients receiving NOBORI stent
consecutive patients receiving RESOLUTE-INTEGRITY stent
consecutive patients receiving XIENCE-XPEDITION stent
consecutive patients receiving BIOMATRIX stent
consecutive patients receiving CILOTAX stent
consecutive patients receiving Drug eluting balloon
consecutive patients receiving DESYNE stent
consecutive patients receiving PROMUS-PREMIER stent
consecutive patients receiving ORSIRO stent
consecutive patients receiving ONYX stent
consecutive patients receiving Bioresorbable Vascular Scaffold
consecutive acute myocardial infarction patients receiving Bioresorbable Vascular Scaffold
consecutive patients receiving Ultimaster stent
consecutive patients receiving Synergy stent
consecutive patients receiving Biofreedom stent
consecutive patients receiving Firehawk stent
DESyne X2
consecutive patients receiving DESyne X2 stent

Primary Outcome Measures :
  1. composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ]

Secondary Outcome Measures :
  1. death (all-cause and cardiac) [ Time Frame: at 12 months and annually up to 5 years ]
  2. myocardial infarction [ Time Frame: at 12 months and annually up to 5 years ]
  3. stent thrombosis [ Time Frame: at 12 months and annually up to 5 years ]
  4. target-lesion and target-vessel revascularization [ Time Frame: at 12 months and annually up to 5 years ]
  5. procedural success [ Time Frame: at 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutive patients amenable to PCI

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186133

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Contact: Seung-Jung Park, MD
Contact: Duk-Woo Park, MD

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Korea, Republic of
Korean centres Recruiting
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
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Study Chair: Seung-Jung Park, MD Asan Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea Identifier: NCT01186133     History of Changes
Other Study ID Numbers: 2010-035
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
coronary disease
drug eluting stent

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