Evaluation of Effectiveness and Safety of NOBORI Stent

Completed

• 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2016-05
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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.

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)

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

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University 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

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