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The IRIS-Resolute Integrity (IRIS-Integrity)

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.
ClinicalTrials.gov Identifier: NCT01392846
Recruitment Status : Active, not recruiting
First Posted : July 13, 2011
Last Update Posted : December 13, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Coronary Artery Disease

Detailed Description:
Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

Study Design

Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Resolute Integrity
Patients receiving Resolute-Integrity stent


Outcome Measures

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

Secondary Outcome Measures :
  1. Death (all cause and cardiac) [ Time Frame: one month ]
  2. Death (all cause and cardiac) [ Time Frame: 6 months ]
  3. Death (all cause and cardiac) [ Time Frame: 12 months and yearly up to 5 years ]
  4. Myocardial Infarction [ Time Frame: one month ]
  5. Myocardial Infarction [ Time Frame: 6 months ]
  6. Myocardial Infarction [ Time Frame: 12 months and yearly upto 5 years ]
  7. Composite of death or MI [ Time Frame: one month ]
  8. Composite of death or MI [ Time Frame: 6 months ]
  9. Composite of death or MI [ Time Frame: 12 months and yearly upto 5 years ]
  10. Composite of cardiac death or MI [ Time Frame: one month ]
  11. Composite of cardiac death or MI [ Time Frame: 6 months ]
  12. Composite of cardiac death or MI [ Time Frame: 12 months and yearly up to 5 years ]
  13. Target Vessel Revascularization [ Time Frame: one month ]
  14. Target Vessel Revascularization [ Time Frame: 6 months ]
  15. Target Vessel Revascularization [ Time Frame: 12 months and yearly up to 5 years ]
  16. Target-lesion revascularization [ Time Frame: one month ]
  17. Target-lesion revascularization [ Time Frame: 6 months ]
  18. Target-lesion revascularization [ Time Frame: 12 months and yearly up to 5 years ]
  19. Stent thrombosis [ Time Frame: one month ]
  20. Stent thrombosis [ Time Frame: 6 months ]
  21. Stent thrombosis [ Time Frame: 12 months and yearly up to 5 years ]
  22. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with coronary artery disease requiring drug eluting stents
Criteria

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
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): NCT01392846


Locations
Korea, Republic of
Inje University Ilsan Paik Hospital
Ilsan, Gyeong-gi, Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
Bucheon, Korea, Republic of
The Catholic University of Korea, Bucheon ST.Mary's Hospital
Bucheon, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
Cheonan, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon, Korea, Republic of
Gang Neung Asan Hospital
Gangneung, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Ilsan, Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Presbyterian Medical Center
Jeonju, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
St.carollo Hospital
Suncheon, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Medtronic
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD 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: NCT01392846     History of Changes
Other Study ID Numbers: CVRF2011-07
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
Coronary artery disease requiring drug eluting stents

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