The IRIS-Resolute Integrity (IRIS-Integrity)

This study is currently recruiting participants.
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
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014