The IRIS-Resolute Integrity (IRIS-Integrity)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by CardioVascular Research Foundation, Korea
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 11, 2013
Last verified: September 2013
  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.


Estimated Enrollment: 3000
Study Start Date: July 2011
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: December 2014 (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

Contacts
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 82-2-3010-3995 dwpark@amc.seoul.kr

Locations
Korea, Republic of
26 Centers Recruiting
Seoul, 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

No publications provided

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 11, 2013
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 October 30, 2014