The IRIS-Resolute Integrity (IRIS-Integrity)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Medtronic
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01392846
First received: July 11, 2011
Last updated: September 9, 2015
Last verified: September 2015
  Purpose
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
Coronary Artery Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) [ Time Frame: 12 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death (all cause and cardiac) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Death (all cause and cardiac) [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 12 months and yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 12 months and yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target-lesion revascularization [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target-lesion revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Procedural success [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 3000
Study Start Date: July 2011
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Resolute Integrity
Patients receiving Resolute-Integrity stent

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 11, 2011
Last Updated: September 9, 2015
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 02, 2016