CClinicalTrials.gg
Sign In
CompletedNCT01348360IRIS-NOBORIUpdated Jan 30, 2020

Evaluation of Effectiveness and Safety of NOBORI Stent

An observational study in Coronary Artery Disease, sponsored by Seung-Jung Park. Completed at 26 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Seung-Jung Park · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 2,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with coronary artery disease requiring drug eluting stents

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

Exclusion Criteria:

  • Patients with a mixture of other DESs.
  • Terminal illness with life expectancy \<1 year.
  • Patients with cardiogenic shock.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (actual)

Groups and cohorts

  • NOBORI stent
06

What researchers measure

Primary outcomes

  1. composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

    Time frame: 12 months post procedure

Secondary outcomes

  1. Death (all cause and cardiac)

    Time frame: one month

  2. Death (all cause and cardiac)

    Time frame: 6 months

  3. Death (all cause and cardiac)

    Time frame: yearly up to 5 years

  4. MI

    Time frame: one month

  5. MI

    Time frame: 6 months

  6. MI

    Time frame: yearly up to 5 years

  7. Composite of death or MI

    Time frame: one month

  8. Composite of cardiac death or MI

    Time frame: one month

  9. Composite of cardiac death or MI

    Time frame: 6 months

  10. Composite of cardiac death or MI

    Time frame: yearly and up to 5 years

  11. Composite of death or MI

    Time frame: 6 months

  12. Composite of death or MI

    Time frame: yearly up to 5 years

  13. TVR

    Time frame: one month

  14. TVR

    Time frame: 6 months

  15. TVR

    Time frame: yearly up to 5 years

  16. Target-lesion revascularization (TLR)

    Time frame: one month

  17. Target-lesion revascularization (TLR)

    Time frame: 6 months

  18. Target-lesion revascularization (TLR)

    Time frame: yearly up to 5 years

  19. Stent thrombosis (ARC criteria)

    Time frame: one month

  20. Stent thrombosis (ARC criteria)

    Time frame: 6 months

  21. Stent thrombosis (ARC criteria)

    Time frame: yearly up to 5 years

  22. 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

07

Study locations

26 sites
  • Asan Medical Center
    Seoul, Republic Of Korea 138-736, 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
  • Asan Medical Center
    GangNeung, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, Korea, Republic of
  • DongGuk University Gyongju Hospital
    Gyeongju, Korea, Republic of
  • National Health Insurance Corporation Ilsan Hospital
    Ilsan, Korea, Republic of
  • Gachon University Gil Hospital
    Incheon, Korea, Republic of
  • Inha University Hospital
    Incheon, Korea, Republic of
  • Chonbuk National University Hospital
    Jeonju, Korea, Republic of
  • Kwangju Christian Hospital
    Kwangju, Korea, Republic of
  • KangBuk Samsung Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • Korea University Hospital
    Seoul, Korea, Republic of
  • Kyung Hee University Medical Hospital
    Seoul, Korea, Republic of
  • St. Mary's Catholic Medical Center
    Seoul, Korea, Republic of
  • The Catholic University of Korea St.Paul's Hospital
    Seoul, Korea, Republic of
  • The Catholic University of Korea Yeouido St.Mary's Hospital
    Seoul, Korea, Republic of
  • The Catholic University of Korea St. Vincent's Hospital
    Suwon, Korea, Republic of
  • The Catholic University of Korea Uijeongbu St. Mary's Hospital
    Uijeongbu, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01348360
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea, Terumo Corporation
Responsible party
Seung-Jung Park (MD, PhD, CardioVascular Research Foundation, Korea) — Sponsor-investigator
First posted
May 5, 2011
Start date
May 2010
Primary completion
May 2016
Completion
Dec 31, 2019
Last update
Jan 30, 2020

Study contacts

Seung-Jung Park, MD, PhD
principal investigator · Asan Medical Center
Ki Bae Seung, MD, PhD
principal investigator · Seoul St. Mary's Hospital, Catholic University of Korea

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease→

Other studies from this sponsor

Seung-Jung Park

Start the discussion