The IRIS-Resolute Integrity (IRIS-Integrity)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01392846
- Lead Sponsor
- Seung-Jung Park
- Brief 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.
- Detailed Description
Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
- 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.
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients presented with cardiogenic shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) 12 months post procedure
- Secondary Outcome Measures
Name Time Method Target-lesion revascularization 12 months and yearly up to 5 years Stent thrombosis 12 months and yearly up to 5 years Stroke 12 months and yearly up to 5 years Procedural success at day 1 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.
Death (all cause and cardiac) 12 months and yearly up to 5 years Myocardial Infarction 12 months and yearly upto 5 years Composite of death or MI 12 months and yearly upto 5 years Composite of cardiac death or MI 12 months and yearly up to 5 years Target Vessel Revascularization 12 months and yearly up to 5 years
Trial Locations
- Locations (23)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Bucheon ST.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Kwangju, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
The Catholic University of Korea, Daejeon ST.Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Pusan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Gyeong-gi, Korea, Republic of
St.carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Gang Neung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of