Coronary Artery DiseaseNCT01392846
The IRIS-Resolute Integrity (IRIS-Integrity)
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 23 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 23 sitesSouth Korea
- Study dates
- Jul 2011to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with coronary artery disease requiring drug eluting stents
Who may be able to join
- 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.
Who cannot join
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients presented with cardiogenic shock
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
South Korea23 sites
Hallym University Sacred Heart Hospital
Anyang
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
The Catholic University of Korea, Bucheon ST.Mary's Hospital
Bucheon-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
Daegu Catholic University Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Yeungnam University Medical Center
Daegu
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Daejeon
Gang Neung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Inje University Ilsan Paik Hospital
Ilsan, Gyeonggi-do
National Health Insurance Corporation Ilsan Hospital
Ilsan
Gachon University Gil Hospital
Incheon
Presbyterian Medical Center
Jeonju
Kwangju Christian Hospital
Kwangju
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Kangdong Sacred Heart Hospital
Seoul
Korea University Guro Hospital
Seoul
St.carollo Hospital
Suncheon
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si
Ulsan University Hospital
Ulsan
About this study
Official title: 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.
Read the detailed description
Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease requiring drug eluting stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resolute Integrity | Patients receiving Resolute-Integrity stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Measured: 12 months post procedure
Secondary outcomes (23)
Death (all cause and cardiac)
Measured: one month
Death (all cause and cardiac)
Measured: 6 months
Death (all cause and cardiac)
Measured: 12 months and yearly up to 5 years
Myocardial Infarction
Measured: one month
Myocardial Infarction
Measured: 6 months
Myocardial Infarction
Measured: 12 months and yearly upto 5 years
Composite of death or MI
Measured: one month
Composite of death or MI
Measured: 6 months
Composite of death or MI
Measured: 12 months and yearly upto 5 years
Composite of cardiac death or MI
Measured: one month
Composite of cardiac death or MI
Measured: 6 months
Composite of cardiac death or MI
Measured: 12 months and yearly up to 5 years
Target Vessel Revascularization
Measured: one month
Target Vessel Revascularization
Measured: 6 months
Target Vessel Revascularization
Measured: 12 months and yearly up to 5 years
Target-lesion revascularization
Measured: one month
Target-lesion revascularization
Measured: 6 months
Target-lesion revascularization
Measured: 12 months and yearly up to 5 years
Stent thrombosis
Measured: one month
Stent thrombosis
Measured: 6 months
Stent thrombosis
Measured: 12 months and yearly up to 5 years
Stroke
Measured: 12 months and yearly up to 5 years
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.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJul 2011
- Primary completion20 Jan 2016
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Medtronic
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392846
- Sponsor's protocol ID
- CVRF2011-07
- Status last verified
- Sep 2021
- First submitted
- 11 Jul 2011
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
- ClinicalTrials.gov ID
- NCT01392846
- Acronym / sponsor ID
- CVRF2011-07
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease requiring drug eluting stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Medtronic
- Study start
- Jul 2011
- Primary completion
- 20 Jan 2016 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resolute Integrity | – | –Patients receiving Resolute-Integrity stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with coronary artery disease requiring drug eluting stents
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients presented with cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Time frame: 12 months post procedure
23 secondary outcomes
Death (all cause and cardiac)
Time frame: one month
Death (all cause and cardiac)
Time frame: 6 months
Death (all cause and cardiac)
Time frame: 12 months and yearly up to 5 years
Myocardial Infarction
Time frame: one month
Myocardial Infarction
Time frame: 6 months
Myocardial Infarction
Time frame: 12 months and yearly upto 5 years
Composite of death or MI
Time frame: one month
Composite of death or MI
Time frame: 6 months
Composite of death or MI
Time frame: 12 months and yearly upto 5 years
Composite of cardiac death or MI
Time frame: one month
Composite of cardiac death or MI
Time frame: 6 months
Composite of cardiac death or MI
Time frame: 12 months and yearly up to 5 years
Target Vessel Revascularization
Time frame: one month
Target Vessel Revascularization
Time frame: 6 months
Target Vessel Revascularization
Time frame: 12 months and yearly up to 5 years
Target-lesion revascularization
Time frame: one month
Target-lesion revascularization
Time frame: 6 months
Target-lesion revascularization
Time frame: 12 months and yearly up to 5 years
Stent thrombosis
Time frame: one month
Stent thrombosis
Time frame: 6 months
Stent thrombosis
Time frame: 12 months and yearly up to 5 years
Stroke
Time frame: 12 months and yearly up to 5 years
Procedural success
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD, PhD principal investigator
Asan Medical Center
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 23 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.