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 October 2015 by CardioVascular Research Foundation, Korea
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
First received: August 19, 2010
Last updated: October 14, 2015
Last verified: October 2015
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.

Coronary Artery Disease
Percutaneous Transluminal Coronary Angioplasty

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25000
Study Start Date: January 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01186133

Contact: Seung-Jung Park, MD sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD dwpark@amc.seoul.kr

Korea, Republic of
Korean centres Recruiting
Various, Korea, Republic of
Contact: Mi-Sun Choi, Project Leader       cvcrc9@amc.seoul.kr   
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Study Chair: Seung-Jung Park, MD Asan Medical Center
  More Information

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01186133     History of Changes
Other Study ID Numbers: 2010-035 
Study First Received: August 19, 2010
Last Updated: October 14, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
drug eluting stent

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

ClinicalTrials.gov processed this record on May 24, 2016