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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Bucheon, Korea, Republic of
    • The catholic university of Korea, Bucheon St.Mary's Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon ST.Mary's Hospital
  • Gangneung, Korea, Republic of
    • Gang Neung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Jeonju, Korea, Republic of
    • Presbyterian Medical Center
  • Kwangju, Korea, Republic of
    • Kwangju Christian Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seoul, 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
  • Suncheon, Korea, Republic of
    • St.Carollo Hospital
  • Uijeongbu, Korea, Republic of
    • The Catholic University of Korea Uijeongbu St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Gyeong-gi
    • Ilsan, Gyeong-gi, Korea, Republic of
      • Inje University Ilsan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with coronary artery disease requiring drug eluting stents

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Resolute Integrity; Patients receiving Resolute-Integrity stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death (all cause and cardiac)		6 months
Composite of death or MI		6 months
Composite of cardiac death or MI		6 months
Target Vessel Revascularization		6 months
Stent thrombosis		6 months
Composite of death or MI		one month
Composite of cardiac death or MI		one month
Myocardial Infarction		6 months
Death (all cause and cardiac)		one month
Death (all cause and cardiac)		12 months and yearly up to 5 years
Myocardial Infarction		one month
Composite of death or MI		12 months and yearly upto 5 years
Composite of cardiac death or MI		12 months and yearly up to 5 years
Target Vessel Revascularization		12 months and yearly up to 5 years
Target Vessel Revascularization		one month
Target-lesion revascularization		one month
Target-lesion revascularization		6 months
Target-lesion revascularization		12 months and yearly up to 5 years
Stent thrombosis		12 months and yearly up to 5 years
Stent thrombosis		one month
Procedural success	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.	at day 1
Myocardial Infarction		12 months and yearly upto 5 years
Stroke		12 months and yearly up to 5 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Medtronic; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 20, 2016
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease requiring drug eluting stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CVRF2011-07