Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01348373
- Lead Sponsor
- Seung-Jung Park
- Brief Summary
The objective of this study is to evaluate effectiveness and safety of GENOUS EPC-coated stent in patients with STEMI with other drug-eluting stents (DESs).
- Detailed Description
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of GENOUS stent in STEMI patients with other-type DESs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 464
- STEMI Patients requiring primary PCI.
- 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 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 ischemic-driven Target- Vessel Revascularization (TVR) 12 months post procedure
- Secondary Outcome Measures
Name Time Method TVR yearly up to 5 years Death (all cause and cardiac) yearly up to 5 years MI yearly up to 5 years Composite of death or MI yearly up to 5 years Composite of cardiac death or MI yearly up to 5 years Target-lesion revascularization (TLR) 6 months Stent thrombosis (ARC criteria) yearly up to 5 years Procedural success (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) in-hospital
Trial Locations
- Locations (16)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Pusan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
SMA-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of