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The IRIS-Resolute Integrity (IRIS-Integrity)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01392846
First Posted: July 13, 2011
Last Update Posted: December 13, 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. Read our disclaimer for details.
Collaborators:
CardioVascular Research Foundation, Korea
Medtronic
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
July 11, 2011
July 13, 2011
December 13, 2016
July 2011
July 2018   (Final data collection date for primary outcome measure)
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) [ Time Frame: 12 months post procedure ]
Same as current
Complete list of historical versions of study NCT01392846 on ClinicalTrials.gov Archive Site
  • Death (all cause and cardiac) [ Time Frame: one month ]
  • Death (all cause and cardiac) [ Time Frame: 6 months ]
  • Death (all cause and cardiac) [ Time Frame: 12 months and yearly up to 5 years ]
  • Myocardial Infarction [ Time Frame: one month ]
  • Myocardial Infarction [ Time Frame: 6 months ]
  • Myocardial Infarction [ Time Frame: 12 months and yearly upto 5 years ]
  • Composite of death or MI [ Time Frame: one month ]
  • Composite of death or MI [ Time Frame: 6 months ]
  • Composite of death or MI [ Time Frame: 12 months and yearly upto 5 years ]
  • Composite of cardiac death or MI [ Time Frame: one month ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ]
  • Composite of cardiac death or MI [ Time Frame: 12 months and yearly up to 5 years ]
  • Target Vessel Revascularization [ Time Frame: one month ]
  • Target Vessel Revascularization [ Time Frame: 6 months ]
  • Target Vessel Revascularization [ Time Frame: 12 months and yearly up to 5 years ]
  • Target-lesion revascularization [ Time Frame: one month ]
  • Target-lesion revascularization [ Time Frame: 6 months ]
  • Target-lesion revascularization [ Time Frame: 12 months and yearly up to 5 years ]
  • Stent thrombosis [ Time Frame: one month ]
  • Stent thrombosis [ Time Frame: 6 months ]
  • Stent thrombosis [ Time Frame: 12 months and yearly up to 5 years ]
  • Procedural success [ Time Frame: at day 1 ]
    It is defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
Same as current
Not Provided
Not Provided
 
The IRIS-Resolute Integrity (IRIS-Integrity)
Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.
Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patients with coronary artery disease requiring drug eluting stents
Coronary Artery Disease
Not Provided
Resolute Integrity
Patients receiving Resolute-Integrity stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2018
July 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with significant coronary artery disease and receiving Resolute Integrity stent.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy <1 year
  • Patients presented with cardiogenic shock
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01392846
CVRF2011-07
Yes
Not Provided
Not Provided
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
  • CardioVascular Research Foundation, Korea
  • Medtronic
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
CardioVascular Research Foundation, Korea
December 2016