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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
  Purpose
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
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

Further study details as provided by Seung-Jung Park, 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25000
Study Start Date: January 2009
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01186133


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

Locations
Korea, Republic of
Korean centres Recruiting
Various, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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
First Submitted: August 19, 2010
First Posted: August 23, 2010
Last Update Posted: December 22, 2016
Last Verified: December 2016
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases