The IRIS-Resolute Integrity (IRIS-Integrity)
This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Seung-Jung Park
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: August 7, 2012
Last verified: August 2012
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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: | 1000 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2013 (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: | August 7, 2012 |
| 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 May 22, 2013