Evaluation of Effectiveness and Safety of BIOMATRIX Stent (IRIS-BIOMATRIX)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01350778
- Lead Sponsor
- Seung-Jung Park
- Brief Summary
The objective of this study is to evaluate effectiveness and safety of BioMatrix 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 BioMatrix stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 837
- Patients receiving BioMatrix 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 Target-lesion revascularization (TLR) yearly upto 5 years Cardiac death yearly upto 5 years TVR yearly upto 5 years All Death yearly upto 5 years MI yearly upto 5 years Composite of death or MI yearly upto 5 years Composite of cardiac death or MI yearly upto 5 years Stent thrombosis (ARC criteria) yearly upto 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 3 days in average At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
Trial Locations
- Locations (20)
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Eulji general hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, 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
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Kwangju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Dong-A Medical Center
🇰🇷Pusan, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St. Paul's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of