Evaluation of Effectiveness and Safety of the GENOUS STENT (IRIS-GENOUS STEMI)
1 other identifier
observational
464
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 11, 2015
November 1, 2015
4.1 years
May 4, 2011
November 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
12 months post procedure
Secondary Outcomes (22)
Death (all cause and cardiac)
one month
Death (all cause and cardiac)
6 months
Death (all cause and cardiac)
yearly up to 5 years
MI
one month
MI
6 months
- +17 more secondary outcomes
Study Arms (1)
GENOUS EPC-coated stent
Patients treated with GENOUS EPC-coated stent
Eligibility Criteria
STEMI Patients requiring primary PCI.
You may qualify if:
- 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
You may not qualify if:
- Patients with a mixture of other DESs
- Terminal illness with life expectancy \<1 year
- Patients with cardiogenic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
- OrbusNeich Medical Korea Co., Ltd.collaborator
Study Sites (16)
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Konyang University Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Pusan National University Yangsan Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
SMA-SNU Boramae Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Wonju Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Ki Bae Seung, MD, PhD
Seoul St. Mary's Hospital, Catholic University of Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 5, 2011
Study Start
May 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 11, 2015
Record last verified: 2015-11