Evaluation of Effectiveness and Safety of NOBORI Stent
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01348360
- Lead Sponsor
- Seung-Jung Park
- 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).
- Detailed Description
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of NOBORI stents versus first-generation DES in patients with coronary artery disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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.
- 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 Death (all cause and cardiac) yearly up to 5 years MI yearly up to 5 years TVR yearly up to 5 years Target-lesion revascularization (TLR) yearly up to 5 years Stent thrombosis (ARC criteria) yearly up to 5 years Composite of death or MI 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) At discharge from the index hospitalization Composite of cardiac death or MI yearly and up to 5 years
Trial Locations
- Locations (25)
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Asan Medical Center
🇰🇷GangNeung, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, 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
Keimyung University Dongsan Medical Center
🇰🇷Daegu, 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
DongGuk University Gyongju Hospital
🇰🇷Gyeongju, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Kwangju, Korea, Republic of
KangBuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
St. Mary's Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Medical Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St.Paul's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
The Catholic University of Korea Yeouido St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of