NCT01348360CompletedNot Applicable
Evaluation of Effectiveness and Safety of NOBORI Stent in Routine Clinical Practice; A Multicenter, Prospective, Observational Study
Seung-Jung Park25 sites in 1 country2,000 target enrollmentStarted: May 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,000
- Locations
- 25
- Primary Endpoint
- composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time Frame: 12 months post procedure
Secondary Outcomes
- 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)
Investigators
Seung-Jung Park
MD, PhD
CardioVascular Research Foundation, Korea
Study Sites (25)
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