Evaluation of Effectiveness and Safety of NOBORI Stent
IRIS-NOBORI
1 other identifier
observational
2,000
1 country
26
Brief Summary
The objective of this study is to evaluate effectiveness and safety of Nobori stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).
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
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 30, 2020
January 1, 2020
6 years
May 4, 2011
January 28, 2020
Conditions
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)
NOBORI stent
Eligibility Criteria
Patients with coronary artery disease requiring drug eluting stents
You may qualify if:
- Patients receiving NOBORI stents.
- 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
- Terumo Corporationcollaborator
Study Sites (26)
Asan Medical Center
Seoul, Republic of Korea, 138-736, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
The Catholic University of Korea, Bucheon ST.Mary's Hospital
Bucheon-si, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
DongGuk University Gyongju Hospital
Gyeongju, South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
KangBuk Samsung Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Korea University Hospital
Seoul, South Korea
Kyung Hee University Medical Hospital
Seoul, South Korea
St. Mary's Catholic Medical Center
Seoul, South Korea
The Catholic University of Korea St.Paul's Hospital
Seoul, South Korea
The Catholic University of Korea Yeouido St.Mary's Hospital
Seoul, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, 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
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 5, 2011
Study Start
May 1, 2010
Primary Completion
May 1, 2016
Study Completion
December 31, 2019
Last Updated
January 30, 2020
Record last verified: 2020-01