Coronary Artery Disease
Conditions
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.
Interventions
None listed
Sponsors
CardioVascular Research Foundation, Korea
Terumo Corporation
Seung-Jung Park
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with a mixture of other DESs. * Terminal illness with life expectancy \<1 year. * Patients with cardiogenic shock.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) | 12 months post procedure |
Secondary
| Measure | Time frame |
|---|---|
| MI | one month |
| Composite of death or MI | one month |
| Composite of cardiac death or MI | one month |
| Death (all cause and cardiac) | one month |
| Target-lesion revascularization (TLR) | one month |
| Stent thrombosis (ARC criteria) | one month |
| 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 |
| TVR | one month |
Countries
South Korea
Outcome results
None listed