Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date May 2010
End date May 2016
Trial size 2000 participants
Trial identifier NCT01348360, CVRF2010-02

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
time frame: 12 months post procedure

Secondary Outcomes

Measure
Death (all cause and cardiac)
time frame: one month
Death (all cause and cardiac)
time frame: 6 months
Death (all cause and cardiac)
time frame: yearly up to 5 years
MI
time frame: one month
MI
time frame: 6 months
MI
time frame: yearly up to 5 years
Composite of death or MI
time frame: one month
Composite of cardiac death or MI
time frame: one month
Composite of cardiac death or MI
time frame: 6 months
Composite of cardiac death or MI
time frame: yearly and up to 5 years
Composite of death or MI
time frame: 6 months
Composite of death or MI
time frame: yearly up to 5 years
TVR
time frame: one month
TVR
time frame: 6 months
TVR
time frame: yearly up to 5 years
Target-lesion revascularization (TLR)
time frame: one month
Target-lesion revascularization (TLR)
time frame: 6 months
Target-lesion revascularization (TLR)
time frame: yearly up to 5 years
Stent thrombosis (ARC criteria)
time frame: one month
Stent thrombosis (ARC criteria)
time frame: 6 months
Stent thrombosis (ARC criteria)
time frame: 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)
time frame: At discharge from the index hospitalization

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study
Principal investigator Seung-Jung Park, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by CardioVascular Research Foundation, Korea.