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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 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
History of Changes
  Purpose

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.


Condition
Coronary Artery Disease

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:

U.S. FDA Resources

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 ] [ 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 ]

Estimated Enrollment: 18600
Study Start Date: January 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186133

Contacts
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

  Show 53 Study Locations
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park Asan Medical Center
  More Information

No publications provided

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: November 22, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
stents

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

ClinicalTrials.gov processed this record on May 22, 2013